Clinical Efficacy of Acupuncture and Paraffin Wax Therapy in the Treatment of Carpal Tunnel Syndrome
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní místa
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Ho Chi Minh City
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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
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Kontakt:
- Nhi Ngoc Xuan Pham, Master
- Telefonní číslo: +84902740678
- E-mail: pnxnhi@uhsvnu.edu.vn
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Kontakt:
- Diem Ngoc Hong Tran, Doctor of Philosophy
- Telefonní číslo: +84907601011
- E-mail: tnhdiem@uhsvnu.edu.vn
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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". |
|
Aktivní komparátor: Paraffin Wax Group
Paraffin wax therapy group will do paraffin wax therapy only in 3 sessions |
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". |
|
Aktivní komparátor: Electroacupuncture group
Electroacupuncture group will receive electroacupuncture only in 3 sesions |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire's symptom severity scale
Časové okno: 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
|
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Functional Status Scale - BCTQ-FSS
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Phalen, Tinel test
Časové okno: 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
|
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Muscle strength assessment
Časové okno: 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
|
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Side effects
Časové okno: periprocedurally
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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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
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