Carpal Tunnel Syndrome
Conditions
Keywords
static magnetic field, permanent magnet, carpal tunnel syndrome, median nerve
Brief summary
The purpose of this Phase II study is to assess the feasibility of conducting a large scale trial which will evaluate the effectiveness of static magnetic field therapy as a treatment for Carpal Tunnel Syndrome. This preliminary study will determine which of three strength magnets to use in the future. 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
See Brief Summary
Interventions
3/4 diameter by 1/8 thick permanent 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
0 Gauss magnets are worn every night during hours of sleep for 6 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
Age range (18-65 years) Both genders Hand or wrist pain with paresthesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night Symptoms present for at least 3 months No prior treatment with magnet therapy Baseline BCTQ \>2.0 on SSS subscale Meet specific EDX inclusion/
Exclusion criteria
listed in Table 1 (below) Willing and able to provide informed consent Ability to read English fluently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Boston Carpal Tunnel Questionnaire Symptom Severity Scale | Baseline, Wks 2, 4, 6, 18 |
Secondary
| Measure | Time frame |
|---|---|
| 1. Electrophysiological recovery of median nerve | Baseline, 6 weeks, 18 weeks |
| 2. General symptom questionnaire | Baseline and on completion of intervention phase |
| 3. Compliance with treatment | Baseline to study completion |
Countries
United States