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Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT04603274
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
University of West Attica
Lilian Voudouri Foundation
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Carpal Tunnel Syndrome Pain Pain Syndrome Pain Syndrome Myofascial Procedure: 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Electroacupuncture in Carpal Tunnel Syndrome: a Clinical, Electrophysiologic and Ultrasonographic Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021


Arm Intervention/treatment
upper extremity diagnosed with carpal tunnel syndrome
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
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603274


Contacts
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Contact: Kassiani Theodoraki, PhD, DESA +306974634162 ktheodoraki@hotmail.com

Locations
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Greece
Pain Clinic of Aretaieion University Hospital Recruiting
Athens, Greece, 11528
Contact: Kassiani Theodoraki       ktheodoraki@hotmail.com   
Principal Investigator: Aikaterini-Maria Ntoutsouli         
Principal Investigator: George Georgoudis         
Principal Investigator: Apostolos Papapostolou         
Laboratory of Musculoskeletal Physiotherapy of University of West Attica Recruiting
Athens, Greece, 12243
Contact: George Georgoudis       physiopain5@gmail.com   
Principal Investigator: Aikaterini-Maria Ntoutsouli         
Principal Investigator: George Georgoudis         
Sponsors and Collaborators
Aretaieion University Hospital
University of West Attica
Lilian Voudouri Foundation
Investigators
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Principal Investigator: Kassiani Theodoraki, PhD, DESA Aretaieion University Hospital
Publications:

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Responsible Party: Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT04603274    
Other Study ID Numbers: 233/30-06-2020 electroacup
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Carpal Tunnel Syndrome
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases