MEDOR: Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

• Sponsor: Institut Bergonié (Other)
• Overall Status: Completed
• CT.gov ID: NCT00712712
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arm: 1
• Actual Duration (Months): 98.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.

PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific	Drug: Acetaminophen; Drug: Morphine Sulfate; Other: Questionnaire administration; Procedure: Quality-of-life assessment; Procedure: Radiofrequency ablation	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases.

Secondary

• Assess minimum and average pain and analyze use of morphine sulfate before and after RFA.

• Determine disease progression by CT scan of bone.

• Evaluate the percentage of relief associated with RFA, specifically patient satisfaction, quality of life, anxiety, depression, and physical performance during RFA.

• Assess complications and side effects related to RFA and the evolution of possible side effects associated with morphine sulfate therapy.

OUTLINE: This is a multicenter study.

Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation (RFA). Patients also complete questionnaires about pain, physical performance, quality of life (QOL), and anxiety at baseline.

Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum pain less than or equal to that at inclusion receive standard morphine sulfate therapy instead.

Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain intensity; side effects and complications of RFA; and total dose of morphine sulfate (or equivalent) is collected daily.

Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at 12 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
• Actual Study Start Date: Dec 24, 2007
• Actual Primary Completion Date: Feb 11, 2016
• Actual Study Completion Date: Mar 16, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Patient who has undergone radiofrequency ablation of bone metastases Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.

Drug: Acetaminophen; Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).; Other Names: Paracetamol ; Drug: Morphine Sulfate; Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.; Other Names: Oral morphine equivalent ; Other: Questionnaire administration; Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on : The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital, the background morphine analgesic treatment during the last 24 hours, the morphine analgesic treatment taken during painful attacks, the possible undesirable effects of morphine treatment. the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent; Procedure: Quality-of-life assessment; Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.; Procedure: Radiofrequency ablation; Recent technique of thermal destruction of tumors. This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser). Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA) [2 months after radiofrequency ablation (RFA)]

   Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.

Secondary Outcome Measures

1. Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation [Inclusion and 2 months after radiofrequency ablation (RFA)]

   Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale. Increased/decreased pain is considered as a variation of at least one point on the numerical scale. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.

2. Intensity of Pain (Minimum, Average, Maximum) [First algology assessment at pre-selection visit]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected at the pre-selection visit.

3. Intensity of Pain (Minimum, Average, Maximum) [Second algology assessment at inclusion visit]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected at the inclusion visit.

4. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment one day before radiofrequency (J-1)]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected one day before radiofrequency (J-1).

5. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment one day after radiofrequency: J+1]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected one day after radiofrequency (J+1).

6. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment at the discharge from hospital visit]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected at the discharge from hospital visit.

7. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment 7 days after discharge from hospital]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 7 days after discharge from hospital.

8. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment 1 month after radiofrequency]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 1 month after radiofrequency.

9. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment 2 months after radiofrequency]

   According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 2 months after radiofrequency.

10. Intensity of Pain (Minimum, Average, Maximum) [Algology assessment 3 months after radiofrequency]

    According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 3 months after radiofrequency.

11. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

12. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [Inclusion: Second algology visit (One week after the first algology visit)]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

13. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [J-1 (One day before radiofrequency)]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

14. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [Discharge from hospital]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

15. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [7 days after discharge]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

16. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [1 month after radiofrequency]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

17. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [2 months after radiofrequency]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

18. Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day [3 months after radiofrequency]

    Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.

19. Total Intravenous Morphine Dose (mg) [24 hours after radiofrequency]

    Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay. As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

20. Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA) [24 hours after radiofrequency]

    As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

21. Standardised Quality of Life Scores (EORTC - QLQ-C30) [Inclusion]

    Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.

22. Standardised Quality of Life Scores (EORTC - QLQ-C30) [2 months after radiofrequency]

    Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer

• Primary or unknown origin

• Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy

• Bone metastases may have been treated with bisphosphonates

• Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria:

• Lesion size ≤ 5 cm

• No more than 2 painful bone metastases

• If 2 lesions are to be treated, distinct anatomical locations can be treated at the same time

• Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed

• Pain located at the tumor or in the area

• Maximum pain in the last 24 hours > 4 points (numerical scale to 11 points)

PATIENT CHARACTERISTICS:

• Life expectancy > 3 months

• Platelet count > 50,000/μL

• Prothrombin < 50%

• Activated cephalin time ≤ 1.5 times normal

• Not pregnant

• Fertile patients must use effective contraception

• No geographical, social, or psychiatric reason that would preclude follow up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• At least 3 weeks since prior chemotherapy or bisphosphonates

• At least 1 week since beginning new painkiller therapy or anticoagulation treatment

• More than 30 days since participation in another drug study

• More than 30 days since prior surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute Bergonié	Bordeaux		France	33076

Sponsors and Collaborators

• Institut Bergonié

Investigators

• Study Chair: Florence Dixmerias, MD, Institut Bergonié

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• National Cancer Institute
• KUSAJILI

Publications

None provided.

• Responsible Party: Institut Bergonié
• ClinicalTrials.gov Identifier: NCT00712712
• Other Study ID Numbers: CDR0000589594; IB-MEDOR; IB-2007-16; INCA-RECF0498; 2007-002686-13
• First Posted: Jul 10, 2008
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut Bergonié: bone metastases; unspecified adult solid tumor, protocol specific; pain
• Additional relevant MeSH terms: Neoplasm Metastasis; Acetaminophen; Morphine

Study Results

Participant Flow

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases Localized Causing Pain
Arm/Group Description	Bone metastases refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Period Title: Overall Study
STARTED	78
COMPLETED	55
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Overall Participants	78
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	66 (11.7)
Sex: Female, Male (Count of Participants)
Female	48 61.5%
Male	30 38.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
France	78 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
Description	Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.
Time Frame	2 months after radiofrequency ablation (RFA)

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Number (95% Confidence Interval) [percentage of participants]	83.6 107.2%

2. Secondary Outcome

Title	Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
Description	Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale. Increased/decreased pain is considered as a variation of at least one point on the numerical scale. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.
Time Frame	Inclusion and 2 months after radiofrequency ablation (RFA)

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Increased pain	4 5.1%
Unchanged pain	2 2.6%
Decreased pain	49 62.8%

3. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected at the pre-selection visit.
Time Frame	First algology assessment at pre-selection visit

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.5 (1.9)
Average pain	5.0 (1.9)
Maximum pain	8.0 (1.4)

4. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected at the inclusion visit.
Time Frame	Second algology assessment at inclusion visit

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	2.0 (2.0)
Average pain	5.0 (1.8)
Maximum pain	8.0 (1.4)

5. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected one day before radiofrequency (J-1).
Time Frame	Algology assessment one day before radiofrequency (J-1)

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	2.0 (1.7)
Average pain	5.0 (1.7)
Maximum pain	7.0 (1.6)

6. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected one day after radiofrequency (J+1).
Time Frame	Algology assessment one day after radiofrequency: J+1

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.0 (1.6)
Average pain	2.0 (2.0)
Maximum pain	4.0 (2.7)

7. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected at the discharge from hospital visit.
Time Frame	Algology assessment at the discharge from hospital visit

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.0 (1.4)
Average pain	2.0 (1.8)
Maximum pain	3.0 (2.6)

8. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 7 days after discharge from hospital.
Time Frame	Algology assessment 7 days after discharge from hospital

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.0 (2.0)
Average pain	2.0 (2.7)
Maximum pain	6.0 (3.1)

9. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 1 month after radiofrequency.
Time Frame	Algology assessment 1 month after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.0 (1.1)
Average pain	2.0 (2.0)
Maximum pain	3.0 (2.6)

10. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 2 months after radiofrequency.
Time Frame	Algology assessment 2 months after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.0 (1.1)
Average pain	2.0 (2.1)
Maximum pain	3.0 (2.7)

11. Secondary Outcome

Title	Intensity of Pain (Minimum, Average, Maximum)
Description	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, Inclusion visit: Second algology assessment (One week after the first algology assessment) J-1: one day before radiofrequency J+1: One day after radiofrequency Discharge from hospital 7 days after discharge from hospital 1 month after radiofrequency 2 months after radiofrequency 3 months after radiofrequency Here, are presented only data collected 3 months after radiofrequency.
Time Frame	Algology assessment 3 months after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Minimal pain	0.0 (1.2)
Average pain	1.0 (2.3)
Maximum pain	2.5 (2.9)

12. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (182.9)

13. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	Inclusion: Second algology visit (One week after the first algology visit)

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (182.9)

14. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	J-1 (One day before radiofrequency)

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (132.8)

15. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	Discharge from hospital

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (115.3)

16. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	7 days after discharge

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (103.1)

17. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	1 month after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (148.0)

18. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	2 months after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	60.0 (148.0)

19. Secondary Outcome

Title	Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Description	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Time Frame	3 months after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg morphine equivalents/day]	50.0 (169.5)

20. Secondary Outcome

Title	Total Intravenous Morphine Dose (mg)
Description	Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay. As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Time Frame	24 hours after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg]	3.0 (72.4)

21. Secondary Outcome

Title	Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
Description	As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Time Frame	24 hours after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Median (Standard Deviation) [mg]	1.0 (6.1)

22. Secondary Outcome

Title	Standardised Quality of Life Scores (EORTC - QLQ-C30)
Description	Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Time Frame	Inclusion

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Physical functioning	46.7 (23.7)
Role functioning	33.3 (32.9)
Emotional functioning	58.3 (24.2)
Cognitive functioning	66.7 (25.6)
Social functioning	33.3 (25.6)
Global health status/QoL	41.7 (17.1)
Fatigue	66.7 (23.1)
Nausea and vomiting	16.7 (26.5)
Pain	83.3 (24.4)
Dyspnoea	33.3 (30.6)
Insomnia	33.3 (31.5)
Appetite loss	0.0 (36.0)
Constipation	33.3 (33.1)
Diarrhoea	0.0 (16.3)
Financial difficulties	0.0 (26.3)

23. Secondary Outcome

Title	Standardised Quality of Life Scores (EORTC - QLQ-C30)
Description	Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Time Frame	2 months after radiofrequency

Outcome Measure Data

Analysis Population Description

Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.

Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Measure Participants	55
Physical functioning	60.0 (23.9)
Role functioning	50.0 (29.9)
Emotional functioning	62.5 (20.8)
Cognitive functioning	50.0 (25.5)
Social functioning	50.0 (33.7)
Global health status/QoL	50.0 (19.0)
Fatigue	55.6 (25.7)
Nausea and vomiting	0.0 (21.3)
Pain	50.0 (28.2)
Dyspnoea	33.3 (33.2)
Insomnia	33.3 (35.0)
Appetite loss	33.3 (35.0)
Constipation	33.3 (37.4)
Diarrhoea	0.0 (23.8)
Financial difficulties	0.0 (16.9)

Adverse Events

Time Frame	All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event Reporting Description	Adverse Event (AE) not including serious has not been collected for this study.
Arm/Group Title	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Arm/Group Description	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
All Cause Mortality
	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
	Affected / at Risk (%)	# Events
Total	10/71 (14.1%)
Serious Adverse Events
	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
	Affected / at Risk (%)	# Events
Total	33/71 (46.5%)
Blood and lymphatic system disorders
Febrile aplasia	1/71 (1.4%)	1
Anemia	5/71 (7%)	9
General disorders
Alteration of the general condition	10/71 (14.1%)	10
Disease-related death	3/71 (4.2%)	3
Fever	1/71 (1.4%)	1
Hepatobiliary disorders
Jaundice	1/71 (1.4%)	1
Injury, poisoning and procedural complications
Fracture	6/71 (8.5%)	6
Immediate post-operative pain increase	1/71 (1.4%)	1
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)	1/71 (1.4%)	1
Musculoskeletal and connective tissue disorders
Bone pain	11/71 (15.5%)	11
Nervous system disorders
Sciatalgy	2/71 (2.8%)	3
Renal and urinary disorders
Dysuric syndrome	1/71 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	1/71 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.