Carpal Tunnel Syndrome (CTS)NCT07789418
Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome
A study testing Thread-Embedding Acupuncture and Electroacupuncture in people with Carpal Tunnel Syndrome (CTS), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study compared thread-embedding acupuncture with electroacupuncture for adults with mild-to-moderate carpal tunnel syndrome confirmed by electrodiagnosis. Eighty participants were randomly assigned in a 1:1 ratio to receive either thread-embedding acupuncture or electroacupuncture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Thread-Embedding Acupuncture and Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 21 Oct 2024to 26 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Primary diagnosis of carpal tunnel syndrome with pain and paresthesia, confirmed by electrodiagnosis and classified as mild or moderate severity.
- Unilateral carpal tunnel syndrome involving either the right or left hand.
- Voluntary written informed consent to participate in the study.
Who cannot join
- Structural wrist damage due to previous surgery or trauma.
- History of carpal tunnel syndrome surgery.
- Carpal tunnel syndrome with an indication for surgical treatment.
- Concomitant cervical radiculopathy, brachial plexopathy, proximal median neuropathy, other upper-limb neuropathies, or polyneuropathy confirmed by electrodiagnosis.
- Systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
- Hypothyroidism.
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- Unstable or untreated severe health conditions, including end-stage renal failure, severe hepatic failure, or NYHA class IV heart failure.
- Use of anti-inflammatory medications within two weeks before enrollment.
- Alcohol or substance abuse.
- Pregnancy or lactation.
- History of allergy, anaphylaxis, or contraindications to thread-embedding acupuncture or electroacupuncture, including emergency conditions, cachexia, local skin infections or dermatological diseases at acupoint sites, or allergy to absorbable sutures.
- Current treatment with anticoagulant drugs or diagnosed coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center Ho Chi Minh City - Campus 3
Ho Chi Minh City, 70000
About this study
Official title: Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome: An Assessor-Blinded Randomized Controlled Trial
This study compared thread-embedding acupuncture with electroacupuncture for adults with mild-to-moderate carpal tunnel syndrome confirmed by electrodiagnosis. Eighty participants were randomly assigned in a 1:1 ratio to receive either thread-embedding acupuncture or electroacupuncture. Both groups also received standard care, including lifestyle modification, nocturnal wrist splinting, nerve and tendon gliding exercises, and paracetamol as needed. Thread-embedding acupuncture was administered twice over two weeks, whereas electroacupuncture was administered 10 times over the same period. Participants were assessed at baseline, week 2, and week 4. The primary outcome was the change in paresthesia intensity from baseline to week 4, measured using a 100-mm visual analog scale. Secondary outcomes included pain intensity, symptom severity, functional status, paracetamol use, and adverse events.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Thread-Embedding Acupuncture, Electroacupuncture, Standard Care
- Keywords
- Thread-Embedding Acupuncture, Electroacupuncture, Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-Embedding AcupunctureProcedure or surgery
Thread-embedding acupuncture was administered twice over two weeks, at baseline and week 1. Sterile polydioxanone thread-embedding needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. The device consisted of a sterile 31-G stainless-steel cannula with a 30-mm needle shaft and a 30-mm polydioxanone thread folded in half, corresponding to an embedded thread length of approximately 15 mm. The thread was placed within the muscle layer and left in situ after withdrawal of the needle.
ElectroacupunctureProcedure or surgery
Electroacupuncture was administered once daily, five times per week for two weeks, for a total of 10 sessions. Sterile disposable needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. Continuous biphasic rectangular pulses with alternating frequencies of 2/100 Hz every 3 seconds and a pulse width of 0.2 ms were delivered for 20 minutes. Stimulation intensity was adjusted within 2-5 mA according to participant tolerance.
Standard CareOther
Both treatment groups received standard care throughout the four-week study period, including lifestyle modification to avoid wrist flexion and strain, nocturnal wrist splinting, daily nerve and tendon gliding exercises, and paracetamol 500 mg as needed for intolerable pain with a minimum four-hour interval between doses.
| Study group | Role | What they receive |
|---|---|---|
| Thread-Embedding Acupuncture | Experimental | Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care. Receives: Procedure: Thread-Embedding Acupuncture; Other: Standard Care |
| Electroacupuncture | Active comparator | Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care. Receives: Procedure: Electroacupuncture; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4
Paresthesia intensity was measured using a self-reported 100-mm visual analog scale ranging from 0 mm, representing no symptom, to 100 mm, representing the worst imaginable symptom. The outcome was the change in paresthesia-VAS score from baseline to week 4.
Measured: Baseline to Week 4
Secondary outcomes (5)
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2
Paresthesia intensity was measured using a self-reported 100-mm visual analog scale ranging from 0 mm, representing no symptom, to 100 mm, representing the worst imaginable symptom. The outcome was the change in paresthesia-VAS score from baseline to week 2.
Measured: Baseline to Week 2
Change From Baseline in Pain Visual Analog Scale Score
Pain intensity was measured using a 100-mm visual analog scale ranging from 0 mm, representing no pain, to 100 mm, representing the worst imaginable pain. The outcome was the change in pain-VAS score from baseline.
Measured: Baseline to Week 2 and Week 4
Change From Baseline in Boston Carpal Tunnel Questionnaire Scores
The Boston Carpal Tunnel Questionnaire consists of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS). The SSS includes 11 items scored from 1 to 5, with a total score ranging from 11 to 55. The FSS includes 8 items scored from 1 to 5, with a total score ranging from 8 to 40. The overall BCTQ score was calculated as the sum of the SSS and FSS scores, ranging from 19 to 95. Higher scores indicate greater symptom severity and functional impairment.
Measured: Baseline to Week 2 and Week 4
Weekly Paracetamol Consumption
Rescue paracetamol use was recorded as the number of 500-mg tablets consumed per week.
Measured: Weekly during the 4-week study period
Adverse Events
Adverse events occurring during the study were monitored and recorded, including events such as ecchymosis and localized pain associated with the acupuncture procedures.
Measured: From baseline through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start21 Oct 2024
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- 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
- Model description
- Two-arm parallel-group randomized controlled trial with a 1:1 allocation ratio comparing thread-embedding acupuncture with electroacupuncture.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Collaborators
- Hoang Binh Trading Services Co., Ltd
- Responsible party
- Principal investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Minh-Man P Bui, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789418
- Sponsor's protocol ID
- 2583/DHYD-HDDD
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome: An Assessor-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07789418
- Acronym / sponsor ID
- 2583/DHYD-HDDD
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Thread-Embedding Acupuncture, Electroacupuncture, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Hoang Binh Trading Services Co., Ltd
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 27 Aug 2026 (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 study compared thread-embedding acupuncture with electroacupuncture for adults with mild-to-moderate carpal tunnel syndrome confirmed by electrodiagnosis. Eighty participants were randomly assigned in a 1:1 ratio to receive either thread-embedding acupuncture or electroacupuncture. Both groups also received standard care, including lifestyle modification, nocturnal wrist splinting, nerve and tendon gliding exercises, and paracetamol as needed. Thread-embedding acupuncture was administered twice over two weeks, whereas electroacupuncture was administered 10 times over the same period. Participants were assessed at baseline, week 2, and week 4. The primary outcome was the change in paresthesia intensity from baseline to week 4, measured using a 100-mm visual analog scale. Secondary outcomes included pain intensity, symptom severity, functional status, paracetamol use, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-group randomized controlled trial with a 1:1 allocation ratio comparing thread-embedding acupuncture with electroacupuncture.
| Arm | Type | Receives |
|---|---|---|
| Thread-Embedding Acupuncture | Experimental | Procedure: Thread-Embedding Acupuncture, Other: Standard CareParticipants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care. |
| Electroacupuncture | Active comparator | Procedure: Electroacupuncture, Other: Standard CareParticipants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Primary diagnosis of carpal tunnel syndrome with pain and paresthesia, confirmed by electrodiagnosis and classified as mild or moderate severity.
- Unilateral carpal tunnel syndrome involving either the right or left hand.
- Voluntary written informed consent to participate in the study.
Key exclusion criteria (12 listed)
- Structural wrist damage due to previous surgery or trauma.
- History of carpal tunnel syndrome surgery.
- Carpal tunnel syndrome with an indication for surgical treatment.
- Concomitant cervical radiculopathy, brachial plexopathy, proximal median neuropathy, other upper-limb neuropathies, or polyneuropathy confirmed by electrodiagnosis.
- Systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
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 |
|---|---|---|
| Thread-Embedding AcupunctureThread-embedding acupuncture was administered twice over two weeks, at baseline and week 1. Sterile polydioxanone thread-embedding needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. The device consisted of a sterile 31-G stainless-steel cannula with a 30-mm needle shaft and a 30-mm polydioxanone thread folded in half, corresponding to an embedded thread length of approximately 15 mm. The thread was placed within the muscle layer and left in situ after withdrawal of the needle. | Procedure or surgery | Thread-Embedding Acupuncture |
| ElectroacupunctureElectroacupuncture was administered once daily, five times per week for two weeks, for a total of 10 sessions. Sterile disposable needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. Continuous biphasic rectangular pulses with alternating frequencies of 2/100 Hz every 3 seconds and a pulse width of 0.2 ms were delivered for 20 minutes. Stimulation intensity was adjusted within 2-5 mA according to participant tolerance. | Procedure or surgery | Electroacupuncture |
| Standard CareBoth treatment groups received standard care throughout the four-week study period, including lifestyle modification to avoid wrist flexion and strain, nocturnal wrist splinting, daily nerve and tendon gliding exercises, and paracetamol 500 mg as needed for intolerable pain with a minimum four-hour interval between doses. | Other | Electroacupuncture, Thread-Embedding Acupuncture |
Primary outcome
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4
Time frame: Baseline to Week 4
Paresthesia intensity was measured using a self-reported 100-mm visual analog scale ranging from 0 mm, representing no symptom, to 100 mm, representing the worst imaginable symptom. The outcome was the change in paresthesia-VAS score from baseline to week 4.
5 secondary outcomes
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2
Time frame: Baseline to Week 2
Change From Baseline in Pain Visual Analog Scale Score
Time frame: Baseline to Week 2 and Week 4
Change From Baseline in Boston Carpal Tunnel Questionnaire Scores
Time frame: Baseline to Week 2 and Week 4
Weekly Paracetamol Consumption
Time frame: Weekly during the 4-week study period
Adverse Events
Time frame: From baseline through Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
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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.
Minh-Man P Bui, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread-Embedding Acupuncture and Electroacupuncture in people with Carpal Tunnel Syndrome (CTS), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4 (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.