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Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

Primary Purpose

Achilles Tendon Rupture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional rehabilitation protocol
Acupuncture-assisted Rehabilitation Protocol
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Rehabilitation, Acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Traditional Rehabilitation Protocol

    Acupuncture-assisted Rehabilitation Protocol

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Range of motion (ROM) recovery time
    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)
    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.

    Full Information

    First Posted
    July 15, 2023
    Last Updated
    July 15, 2023
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05957614
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Achilles Tendon Rupture
    Keywords
    Rehabilitation, Acupuncture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Traditional Rehabilitation Protocol
    Arm Type
    Experimental
    Arm Title
    Acupuncture-assisted Rehabilitation Protocol
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Traditional rehabilitation protocol
    Intervention Description
    Rehabilitation protocol after open surgery for Achilles tendon rupture, including immobilization, early weightbearing ankle motion exercise and isolated early ankle motion exercises.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture-assisted Rehabilitation Protocol
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    The time of return to light sports activity
    Description
    When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.
    Time Frame
    From operation to 1-year follow-up after the surgery
    Secondary Outcome Measure Information:
    Title
    Range of motion (ROM) recovery time
    Description
    The recovery time will be recorded when the ROM is similar to that of the uninjured side.
    Time Frame
    From operation to 1-year follow-up after the surgery
    Title
    Recovery time of the single-legged heel rise height (SHRH)
    Description
    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.
    Time Frame
    From operation to 1-year follow-up after the surgery
    Other Pre-specified Outcome Measures:
    Title
    Visual analogue scale (VAS)
    Description
    VAS pain score is from 0 to 10, the higher score demonstrate the more severe.
    Time Frame
    2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
    Title
    American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
    Description
    The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
    Time Frame
    2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
    Title
    The Achilles tendon Total Rupture Score (ATRS)
    Description
    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.
    Time Frame
    2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

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