Clinical trial NCT05957614: Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture
Official title: A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Rehabilitation
Acupuncture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study is to compare the rehabilitation effect between the patients with achilles tendon rupture using traditional rehabilitation protocol and acupuncture-assisted rehabilitation protocol. The main question it aims to answer is whether acupuncture is an effective rehabilitation treatment. The patients are divided into the traditional rehabilitation group and acupuncture assisted rehabilitation group. The time of return to light sports activity and other indicators of the two groups will be compared.

Detailed description: This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and acupuncture-assisted rehabilitation protocol. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. All patients be treated surgically with the same suture technique. For acupuncture-assisted rehabilitation group, patients will receive additional acupuncture treatment. Investigators will collect indicators from multiple dimensions such as ankle function and pain level to compare the efficacy of the two groups.

The achilles tendon , despite being the largest and strongest tendon, is often prone to ruptures. The latest evidence48 has demonstrated that at centers using functional rehabilitation, nonoperative treatment results in similar rerupture rates but significantly lower complica- tion rates than surgical treatment. So we expect this trial to point out better rehabilitation.

In traditional Chinese acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. Acupuncture has also been widely studied for the treatment of motor system diseases. However, trials on rehabilitation of Achilles tendon rupture are still lacking.

Eligibility criteria: Inclusion Criteria:

* acute closed single-legged complete Achilles tendon rupture
* age of 18 to 60 years.

Exclusion Criteria:

* patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).
* an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) .
* those without rehabilitation or follow-up outcomes.

Primary outcomes:
measure: The time of return to light sports activity
timeFrame: From operation to 1-year follow-up after the surgery
Secondary outcomes:
measure: Range of motion (ROM) recovery time
timeFrame: From operation to 1-year follow-up after the surgery
measure: Recovery time of the single-legged heel rise height (SHRH)
timeFrame: From operation to 1-year follow-up after the surgery
Other outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
measure: American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
timeFrame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
measure: The Achilles tendon Total Rupture Score (ATRS)
timeFrame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Locations:
Study officials:
References: