Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

NCT05957614 | Unknown

• 1 other identifier: PekingUTHLYBLY
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Achilles Tendon Rupture

Keywords

Rehabilitation; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Range of motion (ROM) recovery time

  From operation to 1-year follow-up after the surgery

• Recovery time of the single-legged heel rise height (SHRH)

  From operation to 1-year follow-up after the surgery

Other Outcomes (3)

• Visual analogue scale (VAS)

  2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

• American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score

  2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

• The Achilles tendon Total Rupture Score (ATRS)

  2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

Study Arms (2)

Traditional Rehabilitation Protocol

EXPERIMENTAL

Procedure: Traditional rehabilitation protocol

Acupuncture-assisted Rehabilitation Protocol

ACTIVE COMPARATOR

Procedure: Acupuncture-assisted Rehabilitation Protocol

Interventions

Traditional rehabilitation protocol PROCEDURE

Rehabilitation protocol after open surgery for Achilles tendon rupture, including immobilization, early weightbearing ankle motion exercise and isolated early ankle motion exercises.

Traditional Rehabilitation Protocol

Acupuncture-assisted Rehabilitation Protocol PROCEDURE

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).

Acupuncture-assisted Rehabilitation Protocol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: July 24, 2023
• Study Start: July 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-06