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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01277003
First received: January 13, 2011
Last updated: January 18, 2011
Last verified: November 2010
  Purpose

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 Intervention
Carpal Tunnel Syndrome
Device: Aculife Magnetic Wave Therapist
Device: TENS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • nerve conduction study [ Time Frame: after at least four weeks treatment (at least 16 treatment sesstions) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • questionnaire [ Time Frame: after at least four weeks treatment ( at least 16 treatment sesstions) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01277003

Contacts
Contact: Sui Foon Lo d4659@mail.cmuh.org.tw

Locations
Taiwan
China Medical University Recruiting
Taichung, Taiwan, 404
Contact: Sui Foon Lo       d4659@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01277003     History of Changes
Other Study ID Numbers: 0994266G
Study First Received: January 13, 2011
Last Updated: January 18, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014