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

NCT01277003 | Unknown DMC

• 1 other identifier: 0994266G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• nerve conduction study

  after at least four weeks treatment (at least 16 treatment sesstions)

Secondary Outcomes (1)

• questionnaire

  after at least four weeks treatment ( at least 16 treatment sesstions)

Study Arms (2)

Aculife Magnetic Wave Therapist

EXPERIMENTAL

patients with carpal tunnel syndrome treated with Aculife

Device: Aculife Magnetic Wave Therapist

TENS

ACTIVE COMPARATOR

patients with carpal tunnel syndrome treated by TENS

Device: TENS

Interventions

Aculife Magnetic Wave Therapist DEVICE

two therapeutic points, each for 15 minutes

Aculife Magnetic Wave Therapist

TENS DEVICE

tow therapeutic points, each for 15 minutes

TENS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, Taiwan, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Sui Foon Lo

CONTACT

d4659@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Last Updated: January 19, 2011

Record last verified: 2010-11

Locations

TW (1)