Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

• ClinicalTrials.gov Identifier: NCT05957614
• Recruitment Status: Not yet recruiting
• First Posted: July 24, 2023
• Last Update Posted: July 24, 2023
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Peking University Third Hospital

Tracking Information

• First Submitted Date: July 15, 2023
• First Posted Date: July 24, 2023
• Last Update Posted Date: July 24, 2023
• Estimated Study Start Date: July 15, 2023
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 15, 2023)

The time of return to light sports activity [ Time Frame: From operation to 1-year follow-up after the surgery ]

When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 15, 2023)

• Range of motion (ROM) recovery time [ Time Frame: From operation to 1-year follow-up after the surgery ]
  The recovery time will be recorded when the ROM is similar to that of the uninjured side.
• Recovery time of the single-legged heel rise height (SHRH) [ Time Frame: From operation to 1-year follow-up after the surgery ]
  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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 15, 2023)

• Visual analogue scale (VAS) [ Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery ]
  VAS pain score is from 0 to 10, the higher score demonstrate the more severe.
• American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score [ Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery ]
  The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
• The Achilles tendon Total Rupture Score (ATRS) [ Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Achilles Tendon Rupture

Intervention

• 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.
• 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).

Study Arms

• Experimental: Traditional Rehabilitation Protocol
  Intervention: Procedure: Traditional rehabilitation protocol
• Active Comparator: Acupuncture-assisted Rehabilitation Protocol
  Intervention: Procedure: Acupuncture-assisted Rehabilitation Protocol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 15, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2025
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05957614
• Other Study ID Numbers: PekingUTHLYBLY
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Peking University Third Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking University Third Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Peking University Third Hospital
• Verification Date: June 2023