Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy

Not Applicable

Not yet recruiting

• Conditions: Achilles Tendinopathy
• Interventions: Radiation: Radiofrequency coblation micro-tenotomy

• Registration Number: NCT06342245
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-06-11
• Primary Completion: 2027-06-10
• Study Completion: 2027-06-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• The inclusion is ultrasound-confirmed Achilles tendinopathy. Adults (age >18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. Ultrasonography diagnostic criteria include a thickened Achilles tendon and a Colour Doppler of at least 1 out of 3 in the Öhberg score 2-6 cm proximal to the Achilles tendon insertion. Victorian Institute of Sports Assessment -Achilles (VISA-A) scores below 60 points.

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Exclusion Criteria

• Patients will be excluded if they had a history of major injury or surgery on the affected lower limb in the past year and have mental/physical limitations hindering the participant's ability to complete assessments (ankle arthritis, neuromuscular disorders, etc.), including severe cognitive impairment and psychiatric disorders.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement	Radiofrequency coblation micro-tenotomy	The patient will lie prone on the surgical table, and the area of tendinopathy will be visualized with endoscopy. Endoscopic-assisted creation of a percutaneous mesh (quincunx) pattern of 1mm skin incisions will be made over the area of tendinopathy with a 5mm distance between each incision. Radiofrequency micro-tenotomy with low-temperature controlled ablation will be performed with the TOPAZ (Smith and Nephew) wand, which has a 1mm tip, and full thickness 1mm RF tendon debridement at 5mm intervals will be performed. Incisions will be fixed with sterile strips

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sports Assessment	2weeks, 4 weeks, 2 months, 3 months, 6 months, 1 yesr after sugery	The primary outcome measure will be the Victorian Institute of Sports Assessment - Achilles (VISA-A) questionnaire, either the original English version or the validated Chinese version, depending on the participant's native tongue.