Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis

University of Brasilia

Status and phase: Suspended; Phase 3

Conditions: Hip Osteoarthritis; Chronic Pain

Treatments: Procedure: CRF of anterior sensitive branches to the hip; Procedure: Anesthetic block with steroid injection of anterior sensitive branches to the hip

Study type: Interventional

Funder types: Other

Identifiers

NCT04876859

CAAE: 40347320.1.1001.0025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Conventional Radiofrequency Group

Active Comparator group

Description:

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.

Treatment:

Procedure: CRF of anterior sensitive branches to the hip

Anesthetic plus steroid group

Sham Comparator group

Description:

The sham group will be submitted to the same anesthetic block as described in the intervention group, followed by a simulation of CRF use.

Treatment:

Procedure: Anesthetic block with steroid injection of anterior sensitive branches to the hip