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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency coblation micro-tenotomy

    Radiation

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: radiofrequency coblation micro-tenotomy + endoscopic Achilles debridementExperimental treatment 1 intervention
Group B: endoscopic Achilles debridement onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Victorian Institute of Sports Assessment

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.

Time frame
2weeks, 4 weeks, 2 months, 3 months, 6 months, 1 yesr after sugery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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