Treatment of Chronic Hip Pain by Application of Conventional Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturatory Nerve

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05022381
Collaborator
(none)
55
2
1
14
27.5
2

Study Details

Study Description

Brief Summary

The estimated prevalence of hip joint pain is 7% in men and 10% in women over the age of 45 years.Although physical therapy and weight loss, use of walking aids (such as walking sticks) and analgesic agents are used as conservative treatment methods, these methods usually provide short-term and partial benefits.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain. In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency thermal coagulation of articular branches of femoral and obturator nerves
N/A

Detailed Description

Hip pain is a common medical condition with increasing age.The effectiveness of conservative methods used in hip pain is limited.Since the lifespan of prostheses used in hip surgery is limited, new methods are needed in the treatment of pain.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain.In previous studies with small groups, it was shown that radiofrequency thermocoagulation procedure caused 50% reduction in hip pain between 1-11 months.Hip joint radiofrequency thermocoagulation is a procedure applied in our clinic. In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturatory Nerve in Chronic Hip Pain
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Preoperative and Postoperative Pain Level

The preoperative pain level, hip function and quality of life of patients who underwent radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerve in chronic hip pain will be compared with the postoperative pain level, hip function and quality of life of these patients.

Procedure: Radiofrequency thermal coagulation of articular branches of femoral and obturator nerves
Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury, the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points. Patients who do not have any complications after the procedure and who are mobilized are discharged in the 2nd hour.

Outcome Measures

Primary Outcome Measures

  1. Chronic pain level [1 month,3 month, 6 month]

    For this, the patients' preoperative, 1st month, 3rd month and 6th month VPS (Verbal Pain Score) scores will be checked. A 50% reduction in the verbal pain score will be considered significant.

Secondary Outcome Measures

  1. Hip functional capacity [1month,3 month,6month]

    For this purpose, the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale will be checked at the 1st, 3rd, 6th, 6th months in order to evaluate the functional capacity before the procedure.

Other Outcome Measures

  1. Life Quality [1month, 3 month,6 month]

    For this purpose, patients will be subjected to the Short Form-12- test, which is a short scale of quality of life at 1st month, 3rd month and 6th month.

  2. Acute pain [1 week]

    Week 1 Verbal Pain Score will be checked to observe the improvement in acute pain in patients. A 50% decrease in verbal pain score will be considered significant.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. be over 18 years old

  2. Written consent has been obtained

  3. Those with chronic hip pain for more than 3 weeks

Exclusion Criteria:
  1. Major psychiatric illness

  2. The patient has lumbar compression pain or referred pain

  3. Patients using anticoagulant agents

  4. Patients with infection in the area to be treated

  5. Those who are allergic to local anesthetics

  6. Those who are allergic to betamethasone

  7. Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adnan Menderes University Faculty of Medicine Aydın Province Turkey 09000
2 Adnan Menderes University Faculty of Medicine Aydın Province Turkey 09000

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
sevilay şimşek, Resident doctor, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT05022381
Other Study ID Numbers:
  • 2021/04
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by sevilay şimşek, Resident doctor, Aydin Adnan Menderes University

Study Results

No Results Posted as of Aug 26, 2021