Carpal Tunnel Syndrome and Static Magnetic Field Therapy

NCT00521495 | Unknown Phase 2

• 1 other identifier: R21AT003293
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

static magnetic field; permanent magnet; carpal tunnel syndrome; median nerve

Outcome Measures

Primary Outcomes (1)

• Boston Carpal Tunnel Questionnaire Symptom Severity Scale

  Baseline, Wks 2, 4, 6, 18

Secondary Outcomes (3)

• 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

Study Arms (3)

A

EXPERIMENTAL

Surface magnetic field strength at target 450 Gauss permanent magnet

Device: neodymium permanent magnet; Device: neodymium magnet

B

EXPERIMENTAL

Surface field strength at target 150 Gauss permanent magnet

Device: neodymium magnet

C

ACTIVE COMPARATOR

Device: neodymium magnet; Device: magnet

Interventions

neodymium permanent magnet DEVICE

3/4" diameter by 1/8" thick permanent magnet

A

neodymium magnet DEVICE

A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target

A; B; C

magnet DEVICE

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

C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• National University of Natural Medicine: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

National College of Natural Medicine

Portland, Oregon, 97201, United States

Location

Related Publications (1)

• Colbert AP, Markov MS, Carlson N, Gregory WL, Carlson H, Elmer PJ. Static magnetic field therapy for carpal tunnel syndrome: a feasibility study. Arch Phys Med Rehabil. 2010 Jul;91(7):1098-104. doi: 10.1016/j.apmr.2010.02.013.

  PMID: 20599049 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Agatha P Colbert, MD

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 28, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

US (1)