Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body
Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT03204942
Collaborator
(none)
69
1
3
17.4
4
Study Details
Study Description
Brief Summary
AIM OF THE WORK To evaluate the effectiveness and safety of Pulsed and Thermal Radiofrequency lesion of the dorsal root ganglion (RF-DRG) on a consecutive group of patients presenting with chronic thoracic pain due to vertebral bone metastasis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
STUDY DESIGN This is a Prospective Randomized Controlled trial that will be conducted at the National Cancer Institute. All patients who are eligible for the study will be included and randomized into 3 equal groups.
PATIENTS AND METHODS After approval from the Ethics Committee at the National Cancer Institute, Cairo University, and obtaining written informed consent, eighty-one patients with thoracic segmental pain due to metastasis, unresponsive to conventional therapy and meeting the inclusion criteria will be randomly assigned to either one of the two types of treatment, PRF or TRF lesioning of the DRG or the control group. Patients will be carefully evaluated for neurologic deficits and side effects. Assessment of pain will be done at baseline then at 1, 3, 6 months after the procedure. Randomization will be done using randomized permuted block design. Randomization list will be generated through random.org online site.
Patients will be randomly assigned and divided into 3 equal comparable groups. Before the procedure, laboratory investigations, Dorsal X-ray, CT and MRI will be done. All Patients will be interviewed and examined by physicians trained in interventional pain management. Patients will be carefully assessed on physical exam for sensory, motor, or reflex deficit and carefully documented. Patients will be informed about the technique of the blocks, and written informed consents will be obtained.
The types of measures used to assess pain relief will include single rating scales; VAS, and multiple-dimension composite measures; Oswestry Low Back Pain Disability Questionnaire (ODI), The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BM22.
Study Design
Study Type:
Interventional
Actual Enrollment
:
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison Between Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for the Management of Intractable Metastatic Pain in Thoracic Vertebral Body
Actual Study Start Date
:
Feb 14, 2017
Actual Primary Completion Date
:
Jul 30, 2018
Actual Study Completion Date
:
Jul 30, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: PRF on DRG Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). |
Device: PRF on DRG
RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the stimulation; injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine should be injected through the needle.
|
| Active Comparator: TRF on DRG Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . |
Device: TRF on DRG
Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
| Active Comparator: Control group The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). |
Drug: Corticosteroid injection
Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
Outcome Measures
Primary Outcome Measures
- The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 [Assessment done at 3 months after the procedure.]
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems e.g. a higher score in " Financial difficulties" represents a greater difficulty
- EORTC QLQ-BM22 [Assessment done at 3 months after the procedure.]
The scoring procedure for the QLQ-BM22 module is identical in principle to that for the function and symptom scales/items of the QLQ-C30. Each sub scale is then linearly converted to a score from 0 to 100. For the QLQ-BM22, a higher score indicates worse symptom burden for painful sites and pain characteristics, and better functioning for functional interference and psychosocial aspects. With regards to the positive phrasing of questions 21 and 22, the scoring must be reversed prior to statistical analysis. The item range for each scale/item is 3.
- Visual Analog Scale (VAS), to Evaluate Pain [Assessment of pain done at 3 months after the procedure.]
The VAS is a horizontal line,from 0 to 100 mm in length, anchored by word descriptors at each end such as "no pain" on the left and "severe pain" on the right. The patient marks on the line three pain ratings, corresponding to current, best and worst intensity of pain experienced over the past 24 hours.High VAS means worsening of pain. The average of the 3 ratings will be used to represent the patient's level of pain over the previous 24 hours. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The VAS has consistently demonstrated sensitivity to changes in cancer pain associated with treatment or time ) and usually shows strong associations with other pain intensity ratings, it appears adequately valid and reliable as measures of pain intensity among the many different samples of persons with cancer
- Oswestry Low Back Pain Disability Questionnaire (ODI), [Assessment of pain done at 3 months after the procedure.]
ODI is a self-administered questionnaire divided into ten sections, each with six items designed to assess limitations of various activities of daily living. Each section is scored on a 0 to 5 scale, with 5 representing the greatest disability.If a patient marked more than one statement for a question, the highest scoring statement is recorded as the true indication of disability. The scores are assessed from 0% to 20% to indicate minimal disability, 20% to 40%, to indicate moderate disability, 40% to 60% to indicate severe disability, 60% to 80% to indicate crippled, and 80% to 100% to indicate bed bound or exaggerating their symptoms
Secondary Outcome Measures
- Number of Participants With Any Complications [Assessment done at 3 months after the procedure]
from either the technique as pneumothorax, Neurological defects, Dysthesia and hypoesthesia, anesthesia dolorosa and burning pain or local anesthetic complications.
- To Measure Change in Analgesic Usage [Assessment was done before intervention and at at 3 months after the procedure.]
The change in the pre procedure use of different analgesics in comparison to 3 months later, using Analgesic Quantification Algorithm (AQA).0 No analgesic, 1 Non-opioid analgesics, 2 Weak opioids, 3 Strong opioids ≤75 mg OME per day, 4 Strong opioids >75-150 mg OME per day, 5 Strong opioids >150-300 mg OME per day, 6 Strong opioids >300-600 mg OME per day, 7 Strong opioids >600 mg OME per day.
- Patients' Satisfaction, Descriptive Scale [a week after procedure]
Patients' satisfaction with analgesia through a phone call on 5-level likert scale, (not satisfied at all, only slightly satisfied, somewhat or partly satisfied, very satisfied, perfectly satisfied )
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
-
Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS
5 .
-
Absence of a chronic or progressive motor deficit.
-
Absence of significant sensory deficit.
-
No indication for percutaneous or open surgical intervention.
-
Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.
-
ASA status of II to III .
-
Age > 18 .
-
Body mass index (BMI) :less than forty and more than twenty .
-
Informed consent
Exclusion Criteria:
-
Known sensitivity or contraindication to injected materials: local anesthetics.
-
History of psychological disorders.
-
Evidence of significant neurological deficit.
-
Inability to lie prone.
-
Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
-
Patient refusal.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sherry Nabil Elia Fanous | Cairo | Egypt | 11627 |
Sponsors and Collaborators
- National Cancer Institute, Egypt
Investigators
- Principal Investigator: Sherry Na Fanous, M.Sc., National Cancer Institute, Egypt
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sherry N. Fanous,
Principal Investigator,
National Cancer Institute, Egypt
ClinicalTrials.gov Identifier:
NCT03204942
Other Study ID Numbers:
- CdGrPfMiPnB
First Posted:
Jul 2, 2017
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Sherry N. Fanous,
Principal Investigator,
National Cancer Institute, Egypt
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 140 patients were assessed for primary eligibility using Visual Analogue Scale(VAS).Of which81 only met the inclusion and exclusion criteria. Those 81 were assessed for final eligibility using MRI, CT and bone scan. 69 were included and12 were excluded before randomization due to4 died,4 declined to participate and4 had severe health deterioration |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG). PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st | Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described | The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Period Title: Overall Study | |||
| STARTED | 23 | 23 | 23 |
| COMPLETED | 23 | 23 | 23 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF)on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.2 active cycles per second of 20 milliseconds each , with a voltage output 40-60-V ,impedance between 150-400 Ohms at all levels using Fluroscopic guidance. RF was performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an AP direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. The location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V . injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described | Total of all reporting groups |
| Overall Participants | 23 | 23 | 23 | 69 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
53.87
(10.55)
|
55.78
(7.34)
|
59.39
(13.72)
|
55.8
(10.94)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
13
56.5%
|
15
65.2%
|
13
56.5%
|
41
59.4%
|
| Male |
10
43.5%
|
8
34.8%
|
10
43.5%
|
28
40.6%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
23
100%
|
23
100%
|
23
100%
|
69
100%
|
| Region of Enrollment (participants) [Number] | ||||
| Egypt |
23
100%
|
23
100%
|
23
100%
|
69
100%
|
| Interventional Level (participants) [Number] | ||||
| Dorsal vertebrae 3 |
1
4.3%
|
1
4.3%
|
2
8.7%
|
4
5.8%
|
| Dorsal vertebrae 4 |
1
4.3%
|
4
17.4%
|
2
8.7%
|
7
10.1%
|
| Dorsal vertebrae 5 |
4
17.4%
|
6
26.1%
|
4
17.4%
|
14
20.3%
|
| Dorsal vertebrae 6 |
5
21.7%
|
9
39.1%
|
3
13%
|
17
24.6%
|
| Dorsal vertebrae 7 |
4
17.4%
|
7
30.4%
|
3
13%
|
14
20.3%
|
| Dorsal vertebrae 8 |
2
8.7%
|
8
34.8%
|
4
17.4%
|
14
20.3%
|
| Dorsal vertebrae 9 |
4
17.4%
|
4
17.4%
|
6
26.1%
|
14
20.3%
|
| Dorsal vertebrae 10 |
7
30.4%
|
1
4.3%
|
4
17.4%
|
12
17.4%
|
| Dorsal vertebrae 11 |
3
13%
|
0
0%
|
1
4.3%
|
4
5.8%
|
| Dorsal vertebrae 12 |
6
26.1%
|
0
0%
|
4
17.4%
|
10
14.5%
|
| Cancer Origin (Count of Participants) | ||||
| Bladder |
1
4.3%
|
0
0%
|
1
4.3%
|
2
2.9%
|
| Breast |
10
43.5%
|
12
52.2%
|
12
52.2%
|
34
49.3%
|
| Chest Wall |
1
4.3%
|
0
0%
|
0
0%
|
1
1.4%
|
| Colon |
0
0%
|
1
4.3%
|
0
0%
|
1
1.4%
|
| Endometrial |
0
0%
|
1
4.3%
|
0
0%
|
1
1.4%
|
| Liver |
1
4.3%
|
0
0%
|
0
0%
|
1
1.4%
|
| Lung |
2
8.7%
|
2
8.7%
|
1
4.3%
|
5
7.2%
|
| Lymphoma non-Hodgikin |
0
0%
|
1
4.3%
|
1
4.3%
|
2
2.9%
|
| Lymphoma Hodgikin |
2
8.7%
|
0
0%
|
0
0%
|
2
2.9%
|
| Multiple Myeloma |
0
0%
|
1
4.3%
|
1
4.3%
|
2
2.9%
|
| Ovaries |
2
8.7%
|
1
4.3%
|
1
4.3%
|
4
5.8%
|
| Prostate |
3
13%
|
3
13%
|
4
17.4%
|
10
14.5%
|
| Stomach |
1
4.3%
|
0
0%
|
0
0%
|
1
1.4%
|
| Unknown |
0
0%
|
1
4.3%
|
2
8.7%
|
3
4.3%
|
| Body Mass Index (weight in kg divided by length in m2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [weight in kg divided by length in m2] |
27.54
(5.19)
|
29.55
(6.08)
|
28.50
(6.41)
|
28.829
(5.78117)
|
Outcome Measures
| Title | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 |
|---|---|
| Description | The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems e.g. a higher score in " Financial difficulties" represents a greater difficulty |
| Time Frame | Assessment done at 3 months after the procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| At 3 months post intervention, there are changes in all groups in the Global health of the QLQ-C30 questionnaire. |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG). PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st | Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described | The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Global health status/QoL |
41.30
(9.56)
|
51.08
(9.51)
|
38.76
(12.47)
|
| Physical functioning |
42.48
(20.77)
|
46.53
(19.10)
|
54.96
(15.92)
|
| Role functioning |
59.16
(25.99)
|
62.06
(21.89)
|
65.67
(23.57)
|
| Emotional functioning |
33.42
(24.53)
|
29.43
(22.83)
|
50.09
(22.93)
|
| Cognitive functioning |
26.54
(25.44)
|
30.16
(20.29)
|
38.84
(18.62)
|
| Social functioning |
65.67
(22.47)
|
62.05
(24.60)
|
67.85
(25.28)
|
| Fatigue |
52.67
(16.51)
|
49.27
(14.94)
|
62.33
(13.72)
|
| Nausea and vomiting |
24.64
(23.49)
|
28.26
(16.22)
|
37.68
(23.69)
|
| Pain |
57.25
(18.01)
|
45.64
(17.58)
|
62.32
(14.40)
|
| Dyspnea |
31.87
(23.53)
|
28.97
(23.15)
|
43.47
(23.45)
|
| Insomnia |
52.17
(19.69)
|
49.28
(24.37)
|
55.07
(23.82)
|
| Appetite loss |
43.47
(27.42)
|
37.67
(20.87)
|
57.97
(25.08)
|
| Constipation |
30.43
(31.65)
|
23.17
(21.16)
|
34.77
(30.95)
|
| Diarrhea |
11.59
(19.09)
|
11.58
(16.22)
|
11.58
(16.22)
|
| Financial difficulties |
85.51
(24.26)
|
82.61
(28.20)
|
85.51
(26.26)
|
| Title | EORTC QLQ-BM22 |
|---|---|
| Description | The scoring procedure for the QLQ-BM22 module is identical in principle to that for the function and symptom scales/items of the QLQ-C30. Each sub scale is then linearly converted to a score from 0 to 100. For the QLQ-BM22, a higher score indicates worse symptom burden for painful sites and pain characteristics, and better functioning for functional interference and psychosocial aspects. With regards to the positive phrasing of questions 21 and 22, the scoring must be reversed prior to statistical analysis. The item range for each scale/item is 3. |
| Time Frame | Assessment done at 3 months after the procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The QLQ-BM22 at 3 months post intervention there were changes in terms of Painful sites and Pain characteristics. |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Painful Sites |
50.43
(16.80)
|
35.07
(12.10)
|
44.36
(16.65)
|
| Pain Characteristics |
41.54
(15.09)
|
30.41
(13.90)
|
34.75
(10.75)
|
| Functional Interference |
54.43
(22.62)
|
52.08
(16.33)
|
59.88
(14.64)
|
| Psychosocial Aspects |
51.90
(26.31)
|
56.49
(20.42)
|
51.41
(24.03)
|
| Title | Visual Analog Scale (VAS), to Evaluate Pain |
|---|---|
| Description | The VAS is a horizontal line,from 0 to 100 mm in length, anchored by word descriptors at each end such as "no pain" on the left and "severe pain" on the right. The patient marks on the line three pain ratings, corresponding to current, best and worst intensity of pain experienced over the past 24 hours.High VAS means worsening of pain. The average of the 3 ratings will be used to represent the patient's level of pain over the previous 24 hours. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The VAS has consistently demonstrated sensitivity to changes in cancer pain associated with treatment or time ) and usually shows strong associations with other pain intensity ratings, it appears adequately valid and reliable as measures of pain intensity among the many different samples of persons with cancer |
| Time Frame | Assessment of pain done at 3 months after the procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients receiving PRF treatment changes in VAS% at 3 months. |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Mean (Standard Deviation) [units on a scale] |
68.57
(9.06)
|
48.78
(9.55)
|
66.17
(6.67)
|
| Title | Oswestry Low Back Pain Disability Questionnaire (ODI), |
|---|---|
| Description | ODI is a self-administered questionnaire divided into ten sections, each with six items designed to assess limitations of various activities of daily living. Each section is scored on a 0 to 5 scale, with 5 representing the greatest disability.If a patient marked more than one statement for a question, the highest scoring statement is recorded as the true indication of disability. The scores are assessed from 0% to 20% to indicate minimal disability, 20% to 40%, to indicate moderate disability, 40% to 60% to indicate severe disability, 60% to 80% to indicate crippled, and 80% to 100% to indicate bed bound or exaggerating their symptoms |
| Time Frame | Assessment of pain done at 3 months after the procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TRF group showed changes in pain and ODI% at 3 months. |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waveswas be different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Mean (Standard Deviation) [score on a scale] |
62.52
(12.89)
|
52.87
(11.86)
|
61.61
(8.45)
|
| Title | Number of Participants With Any Complications |
|---|---|
| Description | from either the technique as pneumothorax, Neurological defects, Dysthesia and hypoesthesia, anesthesia dolorosa and burning pain or local anesthetic complications. |
| Time Frame | Assessment done at 3 months after the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| In the TRF group there were some changes |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Number [participants] |
0
0%
|
7
30.4%
|
1
4.3%
|
| Title | To Measure Change in Analgesic Usage |
|---|---|
| Description | The change in the pre procedure use of different analgesics in comparison to 3 months later, using Analgesic Quantification Algorithm (AQA).0 No analgesic, 1 Non-opioid analgesics, 2 Weak opioids, 3 Strong opioids ≤75 mg OME per day, 4 Strong opioids >75-150 mg OME per day, 5 Strong opioids >150-300 mg OME per day, 6 Strong opioids >300-600 mg OME per day, 7 Strong opioids >600 mg OME per day. |
| Time Frame | Assessment was done before intervention and at at 3 months after the procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Opioid consumption varied in the 3 groups |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waveswas different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Before intervention |
4.30
(1.11)
|
4.57
(1.12)
|
3.87
(0.87)
|
| After 3 months |
3.43
(1.12)
|
2.70
(1.26)
|
3.52
(0.95)
|
| Title | Patients' Satisfaction, Descriptive Scale |
|---|---|
| Description | Patients' satisfaction with analgesia through a phone call on 5-level likert scale, (not satisfied at all, only slightly satisfied, somewhat or partly satisfied, very satisfied, perfectly satisfied ) |
| Time Frame | a week after procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| improvement at 5-level Likert Scale was measured in all groups. |
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group |
|---|---|---|---|
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described |
| Measure Participants | 23 | 23 | 23 |
| Very satisfied, perfectly satisfied |
1
4.3%
|
16
69.6%
|
0
0%
|
| Somewhat or partly satisfied |
5
21.7%
|
2
8.7%
|
6
26.1%
|
| Neutral |
9
39.1%
|
4
17.4%
|
4
17.4%
|
| Only slightly satisfied |
7
30.4%
|
1
4.3%
|
13
56.5%
|
| Not satisfied at all |
1
4.3%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse event data were collected over the study course ( 3 months) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse event were collected just post procedure by clinical examination then at 3 months post procedure. | |||||
| Arm/Group Title | PRF on DRG | TRF on DRG | Control Group | |||
| Arm/Group Description | Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG). A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle. | Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) . TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described | The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG). Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described | |||
All Cause Mortality |
||||||
| PRF on DRG | TRF on DRG | Control Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) | |||
Serious Adverse Events |
||||||
| PRF on DRG | TRF on DRG | Control Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| PRF on DRG | TRF on DRG | Control Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 7/23 (30.4%) | 1/23 (4.3%) | |||
| Nervous system disorders | ||||||
| Neuritis | 0/23 (0%) | 4/23 (17.4%) | 0/23 (0%) | |||
| Numbness | 0/23 (0%) | 2/23 (8.7%) | 0/23 (0%) | |||
| Dysethsia | 0/23 (0%) | 1/23 (4.3%) | 0/23 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumothorax | 0/23 (0%) | 0/23 (0%) | 1/23 (4.3%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
| Name/Title | Director of Ethical Committee |
|---|---|
| Organization | National Cancer Institute |
| Phone | +201224276580 |
| drsherryfanous@yahoo.com |
Responsible Party:
Sherry N. Fanous,
Principal Investigator,
National Cancer Institute, Egypt
ClinicalTrials.gov Identifier:
NCT03204942
Other Study ID Numbers:
- CdGrPfMiPnB
First Posted:
Jul 2, 2017
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020