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Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel, Carpal Tunnel Syndrome, Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Clinic of Aretaieion University Hospital
  • Laboratory of Musculoskeletal Physiotherapy of University of West Attica

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

upper extremity diagnosed with carpal tunnel syndrome

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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
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
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)
adverse events
number of patients who develop adverse events
number of patients who require medication throughout treatment
need for additional medication throughout treatment
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

Full Information

First Posted
October 18, 2020
Last Updated
January 30, 2022
Sponsor
Aretaieion University Hospital
Collaborators
University of West Attica, Lilian Voudouri Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04603274
Brief Title
Efficacy of Electroacupuncture in Carpal Tunnel Syndrome
Official Title
Efficacy of Electroacupuncture in Carpal Tunnel Syndrome: a Clinical, Electrophysiologic and Ultrasonographic Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital
Collaborators
University of West Attica, Lilian Voudouri Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel, Carpal Tunnel Syndrome, Pain, Pain Syndrome, Pain Syndrome Myofascial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
upper extremity diagnosed with carpal tunnel syndrome
Arm Type
Other
Arm Description
8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians
Intervention Type
Procedure
Intervention Name(s)
8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome
Intervention Description
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 Measure Information:
Title
change from baseline in Symptom Severity Scale (SSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
Description
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.
Time Frame
3-7 days after the treatment protocol
Secondary Outcome Measure Information:
Title
change from baseline in Functional Status Scale (FSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
Description
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.
Time Frame
3-7 days after the treatment protocol
Title
change from baseline in Visual Analogue Scale (VAS)
Description
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.
Time Frame
3-7 days after the treatment protocol
Title
change from baseline in median sensory nerve conduction velocity (SNCV)
Description
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Time Frame
3-7 days after the treatment protocol
Title
change from baseline in median distal motor latency (DML)
Description
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Time Frame
3-7 days after the treatment protocol
Title
change from baseline in median sensory nerve action potential (SNAP)
Description
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Time Frame
3-7 days after the treatment protocol
Title
change from baseline in cross sectional area of the median nerve
Description
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)
Time Frame
3-7 days after the treatment protocol
Title
adverse events
Description
number of patients who develop adverse events
Time Frame
3-7 days after the treatment protocol
Title
number of patients who require medication throughout treatment
Description
need for additional medication throughout treatment
Time Frame
3-7 days after the treatment protocol
Title
change from baseline in distal sensory latency (DSL) of the median nerve
Description
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Time Frame
3-7 days after the treatment protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Clinic of Aretaieion University Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Laboratory of Musculoskeletal Physiotherapy of University of West Attica
City
Athens
ZIP/Postal Code
12243
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28825339
Citation
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.
Results Reference
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Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

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