Achilles Tendon RuptureNCT05957614
Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture
A study testing Traditional rehabilitation protocol and Acupuncture-assisted Rehabilitation Protocol in people with Achilles Tendon Rupture, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Traditional rehabilitation protocol and Acupuncture-assisted Rehabilitation Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute closed single-legged complete Achilles tendon rupture
- age of 18 to 60 years.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Traditional rehabilitation protocol, Acupuncture-assisted Rehabilitation Protocol
- Keywords
- Rehabilitation, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional rehabilitation protocolProcedure or surgery
Rehabilitation protocol after open surgery for Achilles tendon rupture, including immobilization, early weightbearing ankle motion exercise and isolated early ankle motion exercises.
Acupuncture-assisted Rehabilitation ProtocolProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Traditional Rehabilitation Protocol | Experimental | Not described Receives: Procedure: Traditional rehabilitation protocol |
| Acupuncture-assisted Rehabilitation Protocol | Active comparator | Not described Receives: Procedure: Acupuncture-assisted Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From operation to 1-year follow-up after the surgery
Secondary outcomes (2)
Range of motion (ROM) recovery time
The recovery time will be recorded when the ROM is similar to that of the uninjured side.
Measured: 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.
Measured: From operation to 1-year follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957614
- Sponsor's protocol ID
- PekingUTHLYBLY
- Status last verified
- Jun 2023
- First submitted
- 15 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Si G, Zhang C, Li X, Cao Y, Cui Z, Li J, Wang L, Lv Y, Li D. Acupuncture-Integrated Chinese-Western Medicine Accelerated Rehabilitation Protocol Following Acute Achilles Tendon Repair: A Prospective Cohort Study. Orthop Surg. 2026 May;18(5):1054-1064. doi: 10.1111/os.70309. Epub 2026 Apr 12.
PubMed 41968054
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT05957614
- Acronym / sponsor ID
- PekingUTHLYBLY
- Conditions
- Achilles Tendon Rupture
- Keywords
- Rehabilitation, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Rehabilitation Protocol | Experimental | Procedure: Traditional rehabilitation protocol |
| Acupuncture-assisted Rehabilitation Protocol | Active comparator | Procedure: Acupuncture-assisted Rehabilitation Protocol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- acute closed single-legged complete Achilles tendon rupture
- age of 18 to 60 years.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional rehabilitation protocolRehabilitation protocol after open surgery for Achilles tendon rupture, including immobilization, early weightbearing ankle motion exercise and isolated early ankle motion exercises. | Procedure or surgery | Traditional Rehabilitation Protocol |
| Acupuncture-assisted Rehabilitation ProtocolAdd 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). | Procedure or surgery | Acupuncture-assisted Rehabilitation Protocol |
Primary outcome
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.
2 secondary outcomes
Range of motion (ROM) recovery time
Time frame: From operation to 1-year follow-up after the surgery
Recovery time of the single-legged heel rise height (SHRH)
Time frame: From operation to 1-year follow-up after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 41968054Si G, Zhang C, Li X, Cao Y, Cui Z, Li J, Wang L, Lv Y, Li D. Acupuncture-Integrated Chinese-Western Medicine Accelerated Rehabilitation Protocol Following Acute Achilles Tendon Repair: A Prospective Cohort Study. Orthop Surg. 2026 May;18(5):1054-1064. doi: 10.1111/os.70309. Epub 2026 Apr 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional rehabilitation protocol and Acupuncture-assisted Rehabilitation Protocol in people with Achilles Tendon Rupture, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of return to light sports activity (time frame: From operation to 1-year follow-up after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.