Carpal Tunnel Syndrome and Static Magnetic Field Therapy
NCT ID: NCT00521495
Last Updated: 2009-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2006-09-30
2009-08-31
Brief Summary
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Participants will be recruited from three primary sources. 1) Patients with a possible diagnosis of Carpal Tunnel Syndrome who have been referred to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve conduction studies. If after conducting these studies a potential participant shows evidence of mild to moderate Carpal Tunnel Syndrome s/he will be informed about the study and invited to participate in additional screening. B) Patients seen at the National College of Natural Medicine (NCNM) Clinics who have a clinical diagnosis of Carpal Tunnel Syndrome will be informed about the study and invited to enter the screening process for further eligibility. C) Participants will also be recruited from the general public including staff and students at OHSU and NCNM).
Eligibility will be determined through a stepwise process including telephone screening for general eligibility, Nerve Conduction screening for electrodiagnostic eligibility, and Boston Carpal Tunnel Questionnaire screening for symptom severity eligibility. Those potential participants who meet all eligibility requirements will be randomized to one of three magnetic field dosages. They will be provided with a ¾" diameter x 1/8" thick magnet which they will be required to apply for six weeks during the hours of sleep. Over the course of the study participants will have four visits to the General Clinical Research Center of OHSU and three visits to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve Conduction studies to be performed by either Dr. Nels Carlson or Dr. Hans Carlson.
Questionnaires to be completed during the course of the study include a general health information and demographics questionnaire, the Boston Carpal Tunnel Questionnaire, which will be completed on six occasions, a general symptoms checklist and a Post Treatment Participant satisfaction questionnaire.
Recruitment, retention, compliance and safety will be analyzed using descriptive statistics. Effectiveness of the three different strength magnets will be assessed by comparing participants' baseline scores on the Boston Carpal Tunnel Questionnaire with their scores after six weeks of magnet use.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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A
Surface magnetic field strength at target 450 Gauss permanent magnet
neodymium permanent magnet
3/4" diameter by 1/8" thick permanent magnet
neodymium magnet
A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
B
Surface field strength at target 150 Gauss permanent magnet
neodymium magnet
A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
C
neodymium magnet
A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
magnet
0 Gauss magnets are worn every night during hours of sleep for 6 weeks.
Interventions
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neodymium permanent magnet
3/4" diameter by 1/8" thick permanent magnet
neodymium magnet
A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
magnet
0 Gauss magnets are worn every night during hours of sleep for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Median-ulnar across palm latency difference ≥ 0.4 ms
* Median-radial to thumb latency difference ≥ 0.7 ms
Exclusion Criteria
Concomitant medical conditions including:
Insulin-dependent diabetes mellitus History of chronic renal failure or renal dialysis or forearm fistulae History of generalized peripheral neuropathy History of other neurologic disorders which may confuse the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor Inflammatory articular disease or tendonitis of the involved hand or wrist Other disorders known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis Cancer
* Absent sensory nerve action potential (SNAP)
* Median nerve distal motor latency \> 6.0 ms
18 Years
65 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Oregon Health and Science University
OTHER
National University of Natural Medicine
OTHER
Responsible Party
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National College of Natural Medicine
Principal Investigators
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Agatha P Colbert, MD
Role: PRINCIPAL_INVESTIGATOR
National University of Natural Medicine
Locations
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National College of Natural Medicine
Portland, Oregon, United States
Countries
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References
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