Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With Hip OA Compared to Intra-articular Steroid Injections

Brigham and Women's Hospital60 enrolled

Overview

This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections

This prospective, single-blinded randomized clinical trial investigates the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function compared with standard of care intra-articular steroid injections. This study also aims to determine if CRFA is more effective at decreasing hip pain from OA after treatment and improving hip function in terms of range of motion and walking mobility when compared to corticosteroid hip injections. The primary outcome of interest is a decrease in visual analog scale (VAS) pain as reported following treatment with either a hip injection or following RFA treatment for patients who are not candidates for total hip arthroplasty (THA). Secondary objectives include physical performance at each follow-up time point including range of motion and 50 ft walk test, Hip disability and Osteoarthritis Outcome Score (HOOS) and PROMIS questionnaires at each follow-up time point, patient satisfaction at 24 weeks after treatment, and the number of subjects requesting additional treatment for hip pain during the follow-up period. The assessments will be conducted by comparing patients with pain from hip OA who get CRFA treatment versus patients who get a hip corticosteroid injection. The research hypothesis is that CRFA will lead to a greater reduction in pain up to 24 weeks +/- 2 weeks following treatment compared to a hip corticosteroid injection. This may result in patients having greater relief of their hip pain which may improve joint function and quality of life with the availability of a new alternative to treat hip OA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Hip

Interventions

Cooled RFA treatment with COOLIEF* devicePROCEDURE

Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.

intra-articular corticosteroid injectionDRUG

Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4) 2. Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves Exclusion Criteria: 1. Patients who have received any steroid injection in hip within the last 90 days 2. Individuals who cannot consent for themselves such as children and subjects with impaired decision making 3. Local infection at injection site or active systemic infection 4. Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection) 5. Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist 6. Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment 7. Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol 8. Negative diagnostic nerve block tests

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Change in visual analog scale (VAS) pain by 1.5 points

VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

Time frame: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.

Secondary Outcomes

visual analog scale (VAS) pain scores at each follow-up time point

Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure

Physical performance (hip range of motion)

Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment

Physical performance (50 ft walk test)

Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment

Hip disability and Osteoarthritis Outcome Score (HOOS)

Central Contacts

Antonia F Chen, MD/ MBA

CONTACT

617-535-5935 afchen@bwh.harvard.edu

Data from ClinicalTrials.gov

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