Clinical Efficacy of Acupuncture and Paraffin Wax Therapy in the Treatment of Carpal Tunnel Syndrome

November 6, 2026 updated by: letieunhat, The University of Health Sciences, VNU-HCM

The goal of this clinical trial is to learn if Paraffin wax therapy combined Electroacupuncture works to treat capal tunnel syndrome patients. It will also learn about the safety of Paraffin wax therapy combined Electroacupuncture. The main questions it aims to answer are:

  • To compare the improvement in symptoms and functional status among three treatment groups: electroacupuncture alone, paraffin wax therapy alone, and combined electroacupuncture-paraffin wax therapy in patients with carpal tunnel syndrome.
  • To identify adverse events associated with each treatment modality (electroacupuncture, paraffin wax therapy, and combined electroacupuncture-paraffin wax therapy) in patients with carpal tunnel syndrome.

Participants will:

  • Following the treatment sessions: 5 days per week, total 3 sessions.
  • To be examined by an investigator and answer some questions when admitted and after 3 treatment sesions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

177

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 90001
        • Traditional Medicine Hospital Ho Chi Minh City and Institute of Traditional Medicine Ho Chi Minh City
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of carpal tunnel syndrome symptoms within the median nerve distribution, lasting for at least 3 months, with a CTS-6 score more or equal to 12.
  • Confirmed primary carpal tunnel syndrome of mild-to-moderate severity via electrodiagnostic testing (electrodiagnostic neuromuscular study), corresponding to Bland grades 2-3.
  • No history of carpal tunnel release surgery and no indication for emergency/urgent surgical intervention.
  • Willingness to participate in the study and ability to fully comply with the treatment protocol.

Exclusion Criteria:

  • Secondary carpal tunnel syndrome or confounding neurological/rheumatological conditions: Polyneuropathy; cervical radiculopathy; brachial plexus injury; thoracic outlet syndrome; active rheumatoid arthritis or gout; uncontrolled hypothyroidism; prior wrist trauma or anatomical deformity.
  • Severe carpal tunnel syndrome (Bland grade more than or equal to 4): Thenar muscle atrophy; abductor pollicis brevis or opponens pollicis muscle strength < 4/5; or electrodiagnostic evidence of axonal damage.
  • Prior interventions: History of carpal tunnel release surgery; local corticosteroid injection or systemic corticosteroid use within the past 3 months; or treatment with electroacupuncture, paraffin wax therapy, or specialized physical therapy within 4 weeks prior to enrollment.
  • Local and dermatological contraindications: Open wounds, dermatitis, or active infection at the intervention site; paraffin allergy; loss of protective sensation or thermal (hot-cold) discrimination; severe peripheral vascular disease.
  • Implanted electronic devices and bleeding disorders: Implanted cardiac pacemaker, defibrillator, or other electronic medical devices; clinically significant coagulopathy or conditions compromising safety during electroacupuncture.
  • Uncontrolled cardiovascular conditions: Uncontrolled hypertension, defined as blood pressure more or equal to 180/110 mmHg upon re-measurement; unstable cardiovascular disease, uncontrolled arrhythmia, or decompensated heart failure.
  • Severe systemic comorbidities: Decompensated liver disease or hepatic disease with coagulopathy; chronic kidney disease (CKD) stage 4-5; uncontrolled diabetes mellitus or diabetic polyneuropathy; active malignancy or ongoing chemotherapy.
  • Other exclusion factors: Pregnant women; patients with acute illnesses, cognitive impairment, or inability to comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture and Paraffin Wax Group

Participants in this group will receive both paraffin wax therapy and electroacupuncture following this order: Paraffin wax therapy - 10 minutes break - Electroacupuncture.
Other: Electroapuncture and paraffin wax therapy

Electroacupuncture. Electroacupuncture: Acupuncture will be performed at the Dailang (PC7), Neiguan (PC6), Hegu (LI4), and Yangxi (LI5) acupoints until the deqi sensation is achieved. Following needle insertion, electrical stimulation will be delivered using an electroacupuncture device.

Paraffin wax therapy: Protocol according to Decision No. 3553/QD-BYT dated November 14, 2025, of the Ministry of Health, issuing "Technical Guidelines for Rehabilitation Procedure - Volume 1, Procedure 18 - Paraffin Wax Therapy".
Active Comparator: Paraffin Wax Group

Paraffin wax therapy group will do paraffin wax therapy only in 3 sessions
Device: Paraffin wax therapy

Paraffin wax therapy: Protocol according to Decision No. 3553/QD-BYT dated November 14, 2025, of the Ministry of Health, issuing "Technical Guidelines for Rehabilitation Procedure - Volume 1, Procedure 18 - Paraffin Wax Therapy".
Active Comparator: Electroacupuncture group

Electroacupuncture group will receive electroacupuncture only in 3 sesions
Other: Electropuncture

Electroacupuncture. Electroacupuncture: Acupuncture will be performed at the Dailang (PC7), Neiguan (PC6), Hegu (LI4), and Yangxi (LI5) acupoints until the deqi sensation is achieved. Following needle insertion, electrical stimulation will be delivered using an electroacupuncture device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Questionnaire's symptom severity scale
Time Frame: Baseline (pre-intervention) and after 3 weeks

This questionnaire includes 11 items assessing symptom severity, each scored on a 5-point scale from 1 (mildest) to 5 (most severe).

Total raw score from 11 to 55, final score 1 to 5 (Final score = Raw score / 11). Higher score means greater symptom severity and worse impairment. A score of 1 indicates no symptoms, while a score of 5 indicates severe, constant symptoms.
Baseline (pre-intervention) and after 3 weeks
Functional Status Scale - BCTQ-FSS
Time Frame: Baseline (pre-intervention) and after 3 weeks

This questionnaire includes 8 items assessing function. Each question score from 1 to 5 (1 = No difficulty, 5 = Cannot perform at all due to symptoms) Total raw score is from 8 to 40. Final score is 1 to 5 (Final score = raw score / 8). Higher score means greater functional disability and impairment. A score of 1.0 represents normal hand function, while 5.0 represents complete inability to perform basic tasks.
Baseline (pre-intervention) and after 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phalen, Tinel test
Time Frame: Baseline (pre-intervention) and after 3 weeks

Phalen's Test: Positive if tingling, numbness, or pain in the median nerve distribution is reproduced or worsened within 60 seconds of maximal wrist flexion.

Tinel's Sign: Positive if tapping directly over the median nerve at the flexor retinaculum of the wrist elicits a sensation of tingling or an electric shock-like feeling radiating into the fingers.
Baseline (pre-intervention) and after 3 weeks
Muscle strength assessment
Time Frame: Baseline (pre-intervention) and after 3 weeks

Arm Muscle strength assessment, scale from 0 to 5.

High Score (Grade 5): Normal muscle strength. The muscle can move the joint through its full range of motion against strong manual resistance applied by the examiner.

Low Score (Grade 0): Complete paralysis. No visible muscle contraction or movement occurs.
Baseline (pre-intervention) and after 3 weeks
Side effects
Time Frame: periprocedurally

Unwanted side effects (or adverse events) of electroacupuncture, paraffin wax bath, and the combination of electroacupuncture and paraffin wax bath during the study period.
periprocedurally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Health Sciences, VNU-HCM

Collaborators

Traditional Medicine Hospital of Ho Chi Minh City
Institute of Traditional Medicine, Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2026-44-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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