Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Thread-Embedding Acupuncture, Electroacupuncture, Carpal Tunnel Syndrome
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.
Interventions
PROCEDUREThread-Embedding Acupuncture
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.
PROCEDUREElectroacupuncture
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.
OTHERStandard Care
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Hoang Binh Trading Services Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Two-arm parallel-group randomized controlled trial with a 1:1 allocation ratio comparing thread-embedding acupuncture with electroacupuncture.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2 | Baseline to 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. |
| Change From Baseline in Pain Visual Analog Scale Score | Baseline to Week 2 and Week 4 | 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. |
| Change From Baseline in Boston Carpal Tunnel Questionnaire Scores | Baseline to Week 2 and Week 4 | 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. |
| Weekly Paracetamol Consumption | Weekly during the 4-week study period | Rescue paracetamol use was recorded as the number of 500-mg tablets consumed per week. |
| Adverse Events | From baseline through Week 4 | Adverse events occurring during the study were monitored and recorded, including events such as ecchymosis and localized pain associated with the acupuncture procedures. |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORMinh-Man P Bui, PhD
University of Medicine and Pharmacy at Ho Chi Minh City
Outcome results
None listed