Clinical trial NCT04876859: Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis
Official title: Conventional Radiofrequency of Anterior Sensory Branches in Chronic Hip Pain Due to Hip Osteoarthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Hip Osteoarthritis
Chronic Pain
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,
* VAS ≥ 4
* 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
* Litigation process related to the disease.

Primary outcomes:
measure: Quality of Life (WOMAC)
timeFrame: Baseline to 24 weeks ± 1 week.
Secondary outcomes:
measure: Change in Pain Visual Analogue Scale
timeFrame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
measure: Change in Harris Hip Score (HHS)
timeFrame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
measure: Pain Medication Intake
timeFrame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
measure: Change in Hip muscles Isometric Peak Force
timeFrame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
measure: Change in Hip muscles Time to Reach Peak Force
timeFrame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
measure: Change in Hip muscles Average Force
timeFrame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
measure: Evaluation of intra and inter-rater reliability of Lafayette Manual Muscle Testing System Model-01165 in subjects with hip Osteoarthritis.
timeFrame: Baseline
measure: Change in Global Satisfaction
timeFrame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Other outcomes:
measure: Incidence of Adverse Effects
timeFrame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Locations:
city: Brasília
country: Brazil
facility: Hospital das Forças Armadas
state: Distrito Federal
Study officials:
affiliation: Universidade de Brasilia
name: João Durigan, PhD
role: STUDY_DIRECTOR
References: