Achilles Tendinopathy
Conditions
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.
Interventions
RADIATIONRadiofrequency coblation micro-tenotomy
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a multicentre 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). Investigators will obtain written consent from all participants before the commencement of this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactSamuel Ling
Outcome results
None listed