Clinical trial NCT04603274: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel
Carpal Tunnel Syndrome
Pain
Pain Syndrome
Pain Syndrome Myofascial
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
Collaborators: name: University of West Attica
name: Lilian Voudouri Foundation
First posted: 2020-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change from baseline in Symptom Severity Scale (SSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
timeFrame: 3-7 days after the treatment protocol
Secondary outcomes:
measure: change from baseline in Functional Status Scale (FSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
timeFrame: 3-7 days after the treatment protocol
measure: change from baseline in Visual Analogue Scale (VAS)
timeFrame: 3-7 days after the treatment protocol
measure: change from baseline in median sensory nerve conduction velocity (SNCV)
timeFrame: 3-7 days after the treatment protocol
measure: change from baseline in median distal motor latency (DML)
timeFrame: 3-7 days after the treatment protocol
measure: change from baseline in median sensory nerve action potential (SNAP)
timeFrame: 3-7 days after the treatment protocol
measure: change from baseline in cross sectional area of the median nerve
timeFrame: 3-7 days after the treatment protocol
measure: adverse events
timeFrame: 3-7 days after the treatment protocol
measure: number of patients who require medication throughout treatment
timeFrame: 3-7 days after the treatment protocol
measure: change from baseline in distal sensory latency (DSL) of the median nerve
timeFrame: 3-7 days after the treatment protocol
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Pain Clinic of Aretaieion University Hospital
city: Athens
country: Greece
facility: Laboratory of Musculoskeletal Physiotherapy of University of West Attica
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
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