Overview

This trial is active, not recruiting.

Condition carpal tunnel syndrome
Treatments neodymium permanent magnet, neodymium magnet, magnet
Phase phase 2
Sponsor National College of Natural Medicine
Collaborator National Center for Complementary and Alternative Medicine (NCCAM)
Start date September 2006
End date June 2009
Trial size 60 participants
Trial identifier NCT00521495, R21 AT003293, R21AT003293

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
(Experimental)
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
(Active Comparator)
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.

Primary Outcomes

Measure
Boston Carpal Tunnel Questionnaire Symptom Severity Scale
time frame: Baseline, Wks 2, 4, 6, 18

Secondary Outcomes

Measure
1. Electrophysiological recovery of median nerve
time frame: Baseline, 6 weeks, 18 weeks
2. General symptom questionnaire
time frame: Baseline and on completion of intervention phase
3. Compliance with treatment
time frame: Baseline to study completion

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Carpal Tunnel Syndrome and Static Magnetic Field Therapy
Principal investigator Agatha P Colbert, MD
Description See Brief Summary
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by National College of Natural Medicine.