Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome

NCT07789418 | Completed

• 1 other identifier: 2583/DHYD-HDDD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Thread-Embedding Acupuncture; Electroacupuncture; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4

Secondary Outcomes (5)

• Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2

  Baseline to Week 2

• Change From Baseline in Pain Visual Analog Scale Score

  Baseline to Week 2 and Week 4

• Change From Baseline in Boston Carpal Tunnel Questionnaire Scores

  Baseline to Week 2 and Week 4

• Weekly Paracetamol Consumption

  Weekly during the 4-week study period

• Adverse Events

  From baseline through Week 4

Study Arms (2)

Thread-Embedding Acupuncture

EXPERIMENTAL

Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care.

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.

Procedure: Electroacupuncture; Other: Standard Care

Interventions

Thread-Embedding Acupuncture PROCEDURE

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.

Thread-Embedding Acupuncture

Electroacupuncture PROCEDURE

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.

Electroacupuncture

Standard Care OTHER

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.

Electroacupuncture; Thread-Embedding Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• Hoang Binh Trading Services Co., Ltd: collaborator

Study Sites (1)

University Medical Center Ho Chi Minh City - Campus 3

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Electroacupuncture; Standard of Care

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Minh-Man P Bui, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and care providers were not masked because of the evident differences in treatment procedures and visit frequency. Outcome assessors and data analysts remained blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Two-arm parallel-group randomized controlled trial with a 1:1 allocation ratio comparing thread-embedding acupuncture with electroacupuncture.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: October 21, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning after publication of the study results, with no predetermined end date.
• Access Criteria: De-identified individual participant data will be available to qualified researchers upon reasonable request to the corresponding author. Requests should include the purpose of the proposed analysis and will be considered by the study investigators, subject to applicable ethical and institutional requirements.

Locations

VN (1)