Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

NCT04603274 | Completed

• 1 other identifier: 233/30-06-2020 electroacup
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this clinical study is to assess the effectiveness of electroacupuncture in reducing the severity of symptoms, in improving limb function, in improving the aesthetic and motor conduction of the median nerve and in reducing its cross-sectional area at the inlet of the carpal tunnel in patients with carpal tunnel syndrome. All upper extremities diagnosed with carpal tunnel syndrome will be treated with electroacupuncture for 8 sessions. Clinical, electrophysiological and ultrasonography outcome measures will be evaluated before and after the intervention, to assess the result.

Conditions

Carpal Tunnel; Carpal Tunnel Syndrome; Pain; Pain Syndrome; Pain Syndrome Myofascial

Outcome Measures

Primary Outcomes (1)

• change from baseline in Symptom Severity Scale (SSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)

  The Boston carpal tunnel questionnaire (BCTQ) is an easy, disease-specific measurement of self-reported symptom severity and functional status for carpal tunnel syndrome (CTS). It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and the Functional Status Scale (FSS) containing 8 questions. Each scale using a five-point rating score generates a final score which ranges from 1 to 5, with the higher indicating greater disability. We will use the Greek version of the BCTQ, which had been examined for reliability and validity and responsiveness before and after the intervention.

  3-7 days after the treatment protocol

Secondary Outcomes (9)

• change from baseline in Functional Status Scale (FSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)

  3-7 days after the treatment protocol

• change from baseline in Visual Analogue Scale (VAS)

  3-7 days after the treatment protocol

• change from baseline in median sensory nerve conduction velocity (SNCV)

  3-7 days after the treatment protocol

• change from baseline in median distal motor latency (DML)

  3-7 days after the treatment protocol

• change from baseline in median sensory nerve action potential (SNAP)

  3-7 days after the treatment protocol

Study Arms (1)

upper extremity diagnosed with carpal tunnel syndrome

OTHER

8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians

Procedure: 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome

Interventions

8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome PROCEDURE

All participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians. Acupuncture sterile disposable needles 0,25x 0,25 mm will be inserted for 20 minutes at specific acupuncture points to all patients. Electrical stimulation will be applied at specific acupuncture points for 20 minutes.

upper extremity diagnosed with carpal tunnel syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paraesthesia, numbness, pain in the area of distribution of the median nerve
• worsening of symptoms at night or with repeated movements of the wrist
• aesthetic or/and motor deficits in the area of distribution of the median nerve
• Median sensory nerve conduction velocity (SNCV), first digit to wrist \<42 m/s
• Median distal motor latency (DML), wrist to thenar eminence \>4 ms.
• Difference between the median and radial sensory latencies to the thumb ≥ 0,5 ms.
• Median palmar peak latency (PL)\> 2,2 ms and in comparison to ulnar palmar peak latency ≥ 0,4 ms.
• Median versus Ulnar - Lumbrical - Interossei studies (Difference between the median 2nd lumbrical \& ulnar 1st palmar interosseous distal latency, \>0,5 ms).

You may not qualify if:

• age\<18 years
• absence of the above electrophysiological criteria
• diagnosis of another disease during the electrophysiological test
• patients with severe carpal tunnel syndrome to be operated on
• thenar muscle atrophy
• previous carpal tunnel release surgery
• local steroid injections in the last 3 months
• clinical active rheumatic disease
• diabetic polyneuropathy
• alcoholism
• neurological disease affecting the upper extremity (stroke, multiple sclerosis, amyotrophic lateral sclerosis, cervical radiculopathy, polyneuropathy)
• contraindications to electroacupuncture: pacemaker, epilepsy, skin disorders in the upper extremities
• no consent to the study
• language or communications barriers

Sponsors & Collaborators

• Aretaieion University Hospital: lead
• University of West Attica: collaborator
• Lilian Voudouri Foundation: collaborator

Study Sites (2)

Pain Clinic of Aretaieion University Hospital

Athens, 11528, Greece

Location

Laboratory of Musculoskeletal Physiotherapy of University of West Attica

Athens, 12243, Greece

Location

Related Publications (11)

• Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.

  PMID: 28825339 BACKGROUND

• Graham B, Peljovich AE, Afra R, Cho MS, Gray R, Stephenson J, Gurman A, MacDermid J, Mlady G, Patel AT, Rempel D, Rozental TD, Salajegheh MK, Keith MW, Jevsevar DS, Shea KG, Bozic KJ, Adams J, Evans JM, Lubahn J, Ray WZ, Spinner R, Thomson G, Shaffer WO, Cummins DS, Murray JN, Mohiuddin M, Mullen K, Shores P, Woznica A, Linskey E, Martinez Y, Sevarino K. The American Academy of Orthopaedic Surgeons Evidence-Based Clinical Practice Guideline on: Management of Carpal Tunnel Syndrome. J Bone Joint Surg Am. 2016 Oct 19;98(20):1750-1754. doi: 10.2106/JBJS.16.00719. No abstract available.

  PMID: 27869627 BACKGROUND

• Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome [RETIRED]. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2002 Jun 11;58(11):1589-92. doi: 10.1212/wnl.58.11.1589. No abstract available.

  PMID: 12058083 BACKGROUND

• Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

  PMID: 8245050 BACKGROUND

• McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.

  PMID: 3078045 BACKGROUND

• Michopoulos I, Douzenis A, Kalkavoura C, Christodoulou C, Michalopoulou P, Kalemi G, Fineti K, Patapis P, Protopapas K, Lykouras L. Hospital Anxiety and Depression Scale (HADS): validation in a Greek general hospital sample. Ann Gen Psychiatry. 2008 Mar 6;7:4. doi: 10.1186/1744-859X-7-4.

  PMID: 18325093 BACKGROUND

• Milone MT, Karim A, Klifto CS, Capo JT. Analysis of Expected Costs of Carpal Tunnel Syndrome Treatment Strategies. Hand (N Y). 2019 May;14(3):317-323. doi: 10.1177/1558944717743597. Epub 2017 Nov 22.

  PMID: 29166787 BACKGROUND

• Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.

  PMID: 9325471 BACKGROUND

• Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.

  PMID: 3080166 BACKGROUND

• Wu IX, Lam VC, Ho RS, Cheung WK, Sit RW, Chou LW, Zhang Y, Leung TH, Chung VC. Acupuncture and related interventions for carpal tunnel syndrome: systematic review. Clin Rehabil. 2020 Jan;34(1):34-44. doi: 10.1177/0269215519877511. Epub 2019 Sep 26.

  PMID: 31556315 BACKGROUND

• Ntoutsouli AM, Georgoudis G, Papapostolou A, Karavis M, Petrou DD, Vadalouca A, Theodoraki K. Effects of electroacupuncture on carpal tunnel syndrome: a clinical, electrophysiological and ultrasonographical pilot study. Acupunct Med. 2025 Aug;43(4):198-207. doi: 10.1177/09645284251363989. Epub 2025 Aug 4.

  PMID: 40760926 DERIVED

MeSH Terms

Conditions

Median Neuropathy; Carpal Tunnel Syndrome; Pain; Somatoform Disorders; Fibromyalgia

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 26, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)