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Not yet recruitingNCT07932548Updated Nov 12, 2026

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

A Phase 2/3 interventional study of Electroapuncture and paraffin wax therapy and Electropuncture in Carpal Tunnel Syndrome (CTS), sponsored by The University of Health Sciences, VNU-HCM. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by The University of Health Sciences, VNU-HCM · Phase 2/3, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
177
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Carpal Tunnel Syndrome (CTS)

Keywords

  • carpal tunnel syndrome
  • Electroacupuncture
  • Paraffin wax therapy
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's planned enrollment of 177 is above the median of 60 across 444 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

This is the only study on the registry with The University of Health Sciences, VNU-HCM as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 : 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; 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 or ongoing chemotherapy.
  • Other exclusion factors: Pregnant women; patients with acute illnesses, cognitive impairment, or inability to comply with the study protocol.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
177 participants (estimated)

Study arms

  • 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

  • Active comparator
    Paraffin Wax Group

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

    Device: Paraffin wax therapy

  • Active comparator
    Electroacupuncture group

    Electroacupuncture group will receive electroacupuncture only in 3 sesions

    Other: Electropuncture

Interventions

  • OtherElectroapuncture 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".

  • OtherElectropuncture

    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.

  • DeviceParaffin 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".

06

What researchers measure

Primary outcomes

  1. Boston Carpal Tunnel Questionnaire's symptom severity scale

    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.

    Time frame: Baseline (pre-intervention) and after 3 weeks

  2. Functional Status Scale - BCTQ-FSS

    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.

    Time frame: Baseline (pre-intervention) and after 3 weeks

Secondary outcomes

  1. Phalen, Tinel test

    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.

    Time frame: Baseline (pre-intervention) and after 3 weeks

  2. Muscle strength assessment

    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.

    Time frame: Baseline (pre-intervention) and after 3 weeks

  3. Side effects

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

    Time frame: periprocedurally

07

Study locations

1 site
  • Traditional Medicine Hospital Ho Chi Minh City and Institute of Traditional Medicine Ho Chi Minh City
    Ho Chi Minh City, Ho Chi Minh City 90001, Vietnam
08

References and documents

Publications

  • Sirin Ahisha B, Akkaya Ari S, Paker N, Kesiktas N, Barut Y. Comparison of the efficacy of peloid therapy and paraffin treatment in carpal tunnel syndrome. Int J Biometeorol. 2025 Aug;69(8):1957-1967. doi: 10.1007/s00484-025-02941-4. Epub 2025 May 13. PubMed 40358708 ↗
  • Ordahan B, Karahan AY. Efficacy of paraffin wax bath for carpal tunnel syndrome: a randomized comparative study. Int J Biometeorol. 2017 Dec;61(12):2175-2181. doi: 10.1007/s00484-017-1422-1. Epub 2017 Aug 7. PubMed 28785810 ↗
  • Li T, Yan J, Hu J, Liu X, Wang F. Efficacy and safety of electroacupuncture for carpal tunnel syndrome (CTS): A systematic review and meta-analysis of randomized controlled trials. Front Surg. 2022 Sep 23;9:952361. doi: 10.3389/fsurg.2022.952361. eCollection 2022. PubMed 36211261 ↗
  • Kieu TX, Trinh DT, Jing W. Laser Acupuncture Versus Electroacupuncture for Nonsevere Carpal Tunnel Syndrome: A Randomized Controlled Trial. Med Acupunct. 2024 Jun 21;36(3):125-136. doi: 10.1089/acu.2023.0107. eCollection 2024 Jun. PubMed 39119262 ↗
  • Burton C, Rathod-Mistry T, Blackburn S, Blagojevic-Bucknall M, Chesterton L, Davenport G, Dziedzic K, Higginbottom A, Jowett S, Myers H, Oppong R, van der Windt D, Hay E, Roddy E. The effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome: 24-month follow-up of a randomized trial. Rheumatology (Oxford). 2023 Feb 1;62(2):546-554. doi: 10.1093/rheumatology/keac219. PubMed 35394019 ↗
  • de la Fuente J, Aramendi JF, Ibanez JM, Blasi M, Vazquez A, Aurrekoetxea JJ, Davila F. Minimally invasive ultrasound-guided vs open release for carpal tunnel syndrome in working population: A randomized controlled trial. J Clin Ultrasound. 2021 Sep;49(7):693-703. doi: 10.1002/jcu.23019. Epub 2021 May 27. PubMed 34046894 ↗
  • Aminian-Far A, Pahlevan D, Kohnegi FM. Kinesio taping as an alternative treatment for manual laborers with carpal tunnel syndrome: A double-blind randomized clinical trial. J Back Musculoskelet Rehabil. 2022;35(2):439-447. doi: 10.3233/BMR-210035. PubMed 34275887 ↗
  • Gesslbauer C, Mickel M, Schuhfried O, Huber D, Keilani M, Crevenna R. Effectiveness of focused extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome : A randomized, placebo-controlled pilot study. Wien Klin Wochenschr. 2021 Jun;133(11-12):568-577. doi: 10.1007/s00508-020-01785-9. Epub 2020 Dec 22. PubMed 33351153 ↗
  • Sheereen FJ, Sarkar B, Sahay P, Shaphe MA, Alghadir AH, Iqbal A, Ali T, Ahmad F. Comparison of Two Manual Therapy Programs, including Tendon Gliding Exercises as a Common Adjunct, While Managing the Participants with Chronic Carpal Tunnel Syndrome. Pain Res Manag. 2022 Jun 8;2022:1975803. doi: 10.1155/2022/1975803. eCollection 2022. PubMed 35719196 ↗
  • Ezzati K, Laakso EL, Saberi A, Yousefzadeh Chabok S, Nasiri E, Bakhshayesh Eghbali B. A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome. Eur J Phys Rehabil Med. 2020 Dec;56(6):733-740. doi: 10.23736/S1973-9087.19.05835-0. Epub 2019 Nov 18. PubMed 31742366 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2026
First posted
Nov 12, 2026
StartEst.
Nov 2026
Primary completionEst.
Aug 2027
CompletionEst.
Dec 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932548
Lead 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
Responsible party
letieunhat (Lecturer and Physician, University of Health Sciences, VNU-HCM, The University of Health Sciences, VNU-HCM) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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