To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome

NCT ID: NCT01277003

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Brief Summary

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Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in clinical practice. Patients commonly experience a constellation of symptom complex brought on by compression of the median nerve as it traverse through the carpal tunnel. When compression of the nerve occurs, ischemia and mechanical disruption of nerve function may result. Pathological analysis shows a constellation of nerve injuries. Until now, no satisfactory conservative treatment method. Local steroid injections or oral steroids may result in initial relief, but relapses are frequent and have much side effects, which preclude their routine use for CTS. Full time wrist splints are claimed effective, but compromise hand function and daily activities. There are reasonable studies showing relief of pain with acupuncture on diverse pain conditions. However the therapeutic efficacy of acupuncture in CTS was less convincing in the past. Until recent decade, some case reports and few prospective studies reported the therapeutic effect of acupuncture in CTS. Other study also reported that low-level laser and microamperes transcutaneous electrical nerve stimulation (TENS) are effective in improvement of clinical outcome of patients with CTS. Another report suggested that TENS should be considered for the treatment of painful diabetic peripheral neuropathy. Therefore, the investigators perform this study to evaluate the effect of Aculife Magnetic Wave Therapist (a battery operated device with a probe electrode which contains magnetic elements that transform the oscillating current into an electromagnetic wave to stimulate the acupuncture points, simulate the effect of electroacupuncture ) on CTS and compared with that of Transcutaneous Electrical Nerve Stimulation(TENS). After at least 4 weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated by comparison of symptom severity score, electrophysiological study, sonographic morphology study or magnetic resonance imaging study, before and after treatment, and between the different groups.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Aculife Magnetic Wave Therapist

patients with carpal tunnel syndrome treated with Aculife

Group Type EXPERIMENTAL

Aculife Magnetic Wave Therapist

Intervention Type DEVICE

two therapeutic points, each for 15 minutes

TENS

patients with carpal tunnel syndrome treated by TENS

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

tow therapeutic points, each for 15 minutes

Interventions

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Aculife Magnetic Wave Therapist

two therapeutic points, each for 15 minutes

Intervention Type DEVICE

TENS

tow therapeutic points, each for 15 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* electrodiagnostic study confirmed with carpal tunnel syndrome
* clinical symptom related to carpal tunnel syndrome

Exclusion Criteria

* hypothyroidism, gout, systemic lupus erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, acromegaly, polyneuropathy, brachial plexopathy, proximal median nerve entrapment, deficiency neuropathy (vitamine 2, B12, ect.), drug usage that may cause neuropathy, any surgery for peripheral nerve in the upper limb such as carpal tunnel surgical release, history of trauma in the upper limb such as wrist fracture, or having pregnancy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Locations

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China Medical University

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sui Foon Lo

Role: CONTACT

Facility Contacts

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Sui Foon Lo

Role: primary

Other Identifiers

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0994266G

Identifier Type: -

Identifier Source: org_study_id

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