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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277003
Recruitment Status : Unknown
Verified November 2010 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : January 14, 2011
Last Update Posted : January 19, 2011
Information provided by:
China Medical University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: Aculife Magnetic Wave Therapist Device: TENS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
Study Start Date : December 2010
Estimated Primary Completion Date : February 2011

Arm Intervention/treatment
Experimental: Aculife Magnetic Wave Therapist
patients with carpal tunnel syndrome treated with Aculife
Device: Aculife Magnetic Wave Therapist
two therapeutic points, each for 15 minutes

Active Comparator: TENS
patients with carpal tunnel syndrome treated by TENS
Device: TENS
tow therapeutic points, each for 15 minutes

Primary Outcome Measures :
  1. nerve conduction study [ Time Frame: after at least four weeks treatment (at least 16 treatment sesstions) ]

Secondary Outcome Measures :
  1. questionnaire [ Time Frame: after at least four weeks treatment ( at least 16 treatment sesstions) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01277003

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Contact: Sui Foon Lo

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China Medical University Recruiting
Taichung, Taiwan, 404
Contact: Sui Foon Lo   
Sponsors and Collaborators
China Medical University Hospital

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Responsible Party: China Medical University Hospital Identifier: NCT01277003     History of Changes
Other Study ID Numbers: 0994266G
First Posted: January 14, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: November 2010
Additional relevant MeSH terms:
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Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Wounds and Injuries