Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Procedure: Traditional rehabilitation protocol; Procedure: Acupuncture-assisted Rehabilitation Protocol

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Rehabilitation Protocol	Procedure: Traditional rehabilitation protocol; Rehabilitation protocol after open surgery for Achilles tendon rupture, including immobilization, early weightbearing ankle motion exercise and isolated early ankle motion exercises.
Active Comparator: Acupuncture-assisted Rehabilitation Protocol	Procedure: Acupuncture-assisted Rehabilitation Protocol; Add acupuncture treatment on the basis of traditional rehabilitation protocol.The acupuncture procedure is as follows, acupuncture treatment is carried out for half an hour every day in two weeks after surgery. The acupoints on the affected side are ST36(ZuSanLi), GB34(YangLingQuan) and SP9(YinLingQuan), and the acupoints on the healthy side are Ki3(TaiXi), bl60(KunLun) and PC7(DaLing).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of return to light sports activity	When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.	From operation to 1-year follow-up after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM) recovery time	The recovery time will be recorded when the ROM is similar to that of the uninjured side.	From operation to 1-year follow-up after the surgery
Recovery time of the single-legged heel rise height (SHRH)	The heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.	From operation to 1-year follow-up after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score	The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Visual analogue scale (VAS)	VAS pain score is from 0 to 10, the higher score demonstrate the more severe.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
The Achilles tendon Total Rupture Score (ATRS)	The ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 15, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Acupuncture
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: PekingUTHLYBLY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No