Carpal Tunnel Syndrome and Static Magnetic Field Therapy

Official Title: “Carpal Tunnel Syndrome and Static Magnetic Field Therapy”

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.

See Brief Summary

Intervention(s) in this Clinical Trial

• Device: neodymium permanent magnet
  • 3/4" diameter by 1/8" thick permanent magnet
• Device: 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
• Device: magnet
  • 0 Gauss magnets are worn every night during hours of sleep for 6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Surface magnetic field strength at target 450 Gauss permanent magnet
• Experimental: B
  • Surface field strength at target 150 Gauss permanent magnet
• Active Comparator: C

Primary Measures

• Boston Carpal Tunnel Questionnaire Symptom Severity Scale
  • Time Frame: Baseline, Wks 2, 4, 6, 18
    Safety Issue?: No

Secondary Measures

• 1. Electrophysiological recovery of median nerve
  • Time Frame: Baseline, 6 weeks, 18 weeks
    Safety Issue?: Yes
• 2. General symptom questionnaire
  • Time Frame: Baseline and on completion of intervention phase
    Safety Issue?: No
• 3. Compliance with treatment
  • Time Frame: Baseline to study completion
    Safety Issue?: 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

Exclusion Criteria:

• Use of narcotic analgesia Corticosteroid injection into the carpal tunnel within previous 3 months Prior carpal tunnel surgery on affected side History of wrist or hand fracture on the symptomatic limb Skin rash or irritation on the wrist Participant (or bed partner) wearing a pacemaker or other electronic device Current pregnancy, less than 3 months postpartum, nursing, or planning a pregnancy Plans to move from area during the time frame of the study Inability to tolerate the baseline screening nerve conduction study
• Unable or unwilling to comply with the protocol Collecting workers' compensation or social-security disability benefits Involved in litigation regarding pain or disability
• Development of a rash or skin irritation to the tape applied to the wrist during a run-in baseline test period

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
• Table 1. Electrodiagnostic (EDX) Inclusion and Exclusion Criteria

Inclusion Criteria

• Median nerve onset sensory latency > 3.5 ms at 13 cm
• Median-ulnar across palm latency difference ≥ 0.4 ms
• Median-radial to thumb latency difference ≥ 0.7 ms
• Median-ulnar to ring finger latency difference ≥ 0.5ms ED

Exclusion Criteria

• Absent sensory nerve action potential (SNAP)
• Median nerve distal motor latency > 6.0 ms

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National College of Natural Medicine Other

Overall Clinical Trial Officials and Contacts

Agatha P Colbert, MD Principal Investigator National College of Natural Medicine  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00521495

Study ID Number: R21 AT003293

ClinicalTrials.gov Identifier: NCT00521495

Health Authority: United States: Federal Government