Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Carpal Tunnel, Carpal Tunnel Syndrome, Pain, Pain Syndrome, Pain Syndrome Myofascial

Intervention / Treatment
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* Procedure: 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: upper extremity diagnosed with carpal tunnel syndrome<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Functional Status Scale (FSS) 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 | 
| change from baseline in Visual Analogue Scale (VAS) | 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. | 3-7 days after the treatment protocol | 
| change from baseline in median sensory nerve conduction velocity (SNCV) | Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography | 3-7 days after the treatment protocol | 
| change from baseline in median distal motor latency (DML) | Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography | 3-7 days after the treatment protocol | 
| change from baseline in median sensory nerve action potential (SNAP) | Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography | 3-7 days after the treatment protocol | 
| change from baseline in cross sectional area of the median nerve | 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) | 3-7 days after the treatment protocol | 
| adverse events | number of patients who develop adverse events | 3-7 days after the treatment protocol | 
| number of patients who require medication throughout treatment | need for additional medication throughout treatment | 3-7 days after the treatment protocol | 
| change from baseline in distal sensory latency (DSL) of the median nerve | Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography | 3-7 days after the treatment protocol |