To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aculife Magnetic Wave Therapist
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility 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.
Sites / Locations
- China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aculife Magnetic Wave Therapist
TENS
Arm Description
patients with carpal tunnel syndrome treated with Aculife
patients with carpal tunnel syndrome treated by TENS
Outcomes
Primary Outcome Measures
nerve conduction study
Secondary Outcome Measures
questionnaire
Full Information
NCT ID
NCT01277003
First Posted
January 13, 2011
Last Updated
January 18, 2011
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01277003
Brief Title
To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
Official Title
To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
China Medical University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aculife Magnetic Wave Therapist
Arm Type
Experimental
Arm Description
patients with carpal tunnel syndrome treated with Aculife
Arm Title
TENS
Arm Type
Active Comparator
Arm Description
patients with carpal tunnel syndrome treated by TENS
Intervention Type
Device
Intervention Name(s)
Aculife Magnetic Wave Therapist
Intervention Description
two therapeutic points, each for 15 minutes
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
tow therapeutic points, each for 15 minutes
Primary Outcome Measure Information:
Title
nerve conduction study
Time Frame
after at least four weeks treatment (at least 16 treatment sesstions)
Secondary Outcome Measure Information:
Title
questionnaire
Time Frame
after at least four weeks treatment ( at least 16 treatment sesstions)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sui Foon Lo
Email
d4659@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sui Foon Lo
Email
d4659@mail.cmuh.org.tw
12. IPD Sharing Statement
Learn more about this trial
To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome
We'll reach out to this number within 24 hrs