Conventional Radiofrequency of Anterior Sensory Branches in Chronic Hip Pain Due to Hip Osteoarthritis: A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hip Osteoarthritis
- Sponsor
- University of Brasilia
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Quality of Life (WOMAC)
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.
Detailed Description
This prospective, double-blinded (participant and outcome assessor) clinical trial was designed to investigate the results of the intervention Continuous Radiofrequency (CRF) in the treatment of participants with chronic hip pain secondary to hip osteoarthritis. Participants will be randomized in a 2-arm, parallel groups. The intervention group will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. The sham group will be submitted to the same anesthetic block, followed by a simulation of CRF use. The surgeon performing the procedures will only be informed of the randomization after completing the anesthetic block on the participants to avoid bias at its accuracy. Participants will be evaluated at four follow-up: before intervention and after 1, 12, and 24 weeks, to access the Western Ontario and McMaster Universities score (WOMAC) as the primary outcome.
Investigators
João Luiz Q. Durigan
Professor
University of Brasilia
Eligibility Criteria
Inclusion Criteria
- •Participants 18 years or older
- •Symptomatic unilateral hip osteoarthritis (OA)
- •Pain for more than 6 months in the groin, anterior, anterolateral ou lateral region
- •OA radiologically classified as Kellgren and Lawrence Tipo II-IV,
- •Considered non-responder to conservative treatment for the participant for 6 months.
- •In case of difficulty in selecting participants with symptomatic unilateral OA, symptomatic bilateral hip OA will be admitted and submitted to the same treatment on both sides, after notification and approval from the Ethic Board of each institution involved.
Exclusion Criteria
- •Participants with radiculopathy ipsolateral
- •Knee OA ipsolateral,
- •Previous hip arthroplasty
- •Pain exclusively in the posterior region of the hip
- •Infiltration of the hip for less than 3 months
- •Neurological disease compromising gait
- •Peripheral neuropathy
- •Psychiatric disease that compromise collaboration with the protocol
- •Implanted pacemaker
- •Prothrombin Activity Time (PT/INR) \> 3 and
Outcomes
Primary Outcomes
Quality of Life (WOMAC)
Time Frame: Baseline to 24 weeks ± 1 week.
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
Secondary Outcomes
- Pain Medication Intake(Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)
- Change in Hip muscles Isometric Peak Force(Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)
- Change in Global Satisfaction(1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)
- Change in Pain Visual Analogue Scale(Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)
- Change in Harris Hip Score (HHS)(Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)
- Change in Hip muscles Time to Reach Peak Force(Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)
- Evaluation of intra and inter-rater reliability of Lafayette Manual Muscle Testing System Model-01165 in subjects with hip Osteoarthritis.(Baseline)
- Change in Hip muscles Average Force(Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.)