Efficacy of Electroacupuncture in Carpal Tunnel Syndrome

NCT ID: NCT04603274

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

upper extremity diagnosed with carpal tunnel syndrome

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

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of West Attica

OTHER

Sponsor Role: collaborator

Lilian Voudouri Foundation

UNKNOWN

Sponsor Role: collaborator

Aretaieion University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Kassiani Theodoraki

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kassiani Theodoraki, PhD, DESA

Role: PRINCIPAL_INVESTIGATOR

Aretaieion University Hospital

Locations

Pain Clinic of Aretaieion University Hospital

Athens, , Greece

Laboratory of Musculoskeletal Physiotherapy of University of West Attica

Athens, , Greece

Countries

Greece

References

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Other Identifiers

233/30-06-2020 electroacup

Identifier Type: -

Identifier Source: org_study_id