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

Sponsor
China Medical University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01277003
Collaborator
(none)
30
1
2

Study Details

Study Description

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
  • Device: Aculife Magnetic Wave Therapist
  • Device: TENS
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2010
Anticipated Primary Completion Date :
Feb 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. nerve conduction study [after at least four weeks treatment (at least 16 treatment sesstions)]

Secondary Outcome Measures

  1. questionnaire [after at least four weeks treatment ( at least 16 treatment sesstions)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Taichung Taiwan 404

Sponsors and Collaborators

  • China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01277003
Other Study ID Numbers:
  • 0994266G
First Posted:
Jan 14, 2011
Last Update Posted:
Jan 19, 2011
Last Verified:
Nov 1, 2010
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2011