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Completed

NCT Number: NCT04603274

Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

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.

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Key information

About this study

Carpal tunnel syndrome (CTS) is the most common mononeuritis, with a significant burden on both patients and public health. For mild and moderate cases, conservative methods, including immobilization, corticosteroid injections, oral medications and physical therapy have been suggested as appropriate treatments, with mixed results. Acupuncture and related therapies has been used worldwide over the last few years in the management of CTS, with generally positive results. However, more studies will be needed to assess the role of acupuncture as an independent therapeutic modality to CTS.

This is a clinical study that will be conducted in the pain clinic at the department of Anaesthesiology of Aretaieion University Hospital as well as in the Laboratory of Musculoskeletal Physiotherapy of University of West Attica, with which there is a cooperation agreement. All recruited participants will be treated with the same acupuncture protocol at the limb that will be diagnosed with carpal tunnel syndrome. If the patients are diagnosed with bilateral CTS, both wrists will be treated. Clinical, electrophysiological and ultrasonography outcomes will be measured before and after the intervention.

In order to record the possible influence of psychosomatic characteristics, the Greek version of the Hospital Anxiety & Depression (HAD) Scale will be used before the treatment. As a result the anxiety and the depression of the participants will be quantified with a simple clinical tool.

All participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians.

All participants in the study will be evaluated 3-7 days before and 3-7 days after the treatment protocol with clinical, electrophysiological and ultrasonographical outcome measures. In patients with bilateral symptoms, each limb will be assessed separately.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3-7 days after the treatment protocol

    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.

Secondary outcomes

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

    Time frame: 3-7 days after the treatment protocol

    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.

  2. change from baseline in Visual Analogue Scale (VAS)

    Time frame: 3-7 days after the treatment protocol

    The Visual Analogue Scale (VAS) will be used to measure the severity of pain induced by carpal tunnel syndrome before and after the intervention. Zero is the minimum score and ten is the maximum score for pain.

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

    Time frame: 3-7 days after the treatment protocol

    Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography

  4. change from baseline in median distal motor latency (DML)

    Time frame: 3-7 days after the treatment protocol

    Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography

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

    Time frame: 3-7 days after the treatment protocol

    Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography

  6. change from baseline in cross sectional area of the median nerve

    Time frame: 3-7 days after the treatment protocol

    The Cross sectional area (CSA) of the median nerve at the inlet of carpal tunnel (at the level of pisiform and scaphoid bone) will be measured before and after treatment by the Sonosite edge Ultrasound machine (6 MHz- 15 MHz linear probe)

  7. adverse events

    Time frame: 3-7 days after the treatment protocol

    number of patients who develop adverse events

  8. number of patients who require medication throughout treatment

    Time frame: 3-7 days after the treatment protocol

    need for additional medication throughout treatment

  9. change from baseline in distal sensory latency (DSL) of the median nerve

    Time frame: 3-7 days after the treatment protocol

    Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Collaborators

  • Lilian Voudouri Foundation
  • University of West Attica

Registry information

Official study title

Efficacy of Electroacupuncture in Carpal Tunnel Syndrome: a Clinical, Electrophysiologic and Ultrasonographic Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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