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Carpal Tunnel Syndrome and Static Magnetic Field Therapy

Carpal Tunnel Syndrome and Static Magnetic Field Therapy

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00521495
Acronym
CTS/SMF
Enrollment
60
Registered
2007-08-28
Start date
2006-09-30
Completion date
2009-08-31
Last updated
2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

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

DEVICEneodymium permanent magnet

3/4 diameter by 1/8 thick permanent magnet

DEVICEneodymium 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

DEVICEmagnet

0 Gauss magnets are worn every night during hours of sleep for 6 weeks.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Oregon Health and Science University
CollaboratorOTHER
National University of Natural Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frame
Boston Carpal Tunnel Questionnaire Symptom Severity ScaleBaseline, Wks 2, 4, 6, 18

Secondary

MeasureTime frame
1. Electrophysiological recovery of median nerveBaseline, 6 weeks, 18 weeks
2. General symptom questionnaireBaseline and on completion of intervention phase
3. Compliance with treatmentBaseline to study completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026