Trial record 7 of 82 for:    "Carpal Tunnel Syndrome"

Carpal Tunnel Syndrome and Static Magnetic Field Therapy (CTS/SMF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National College of Natural Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by:
National College of Natural Medicine
ClinicalTrials.gov Identifier:
NCT00521495
First received: August 24, 2007
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Carpal Tunnel Syndrome
Device: neodymium permanent magnet
Device: neodymium magnet
Device: magnet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carpal Tunnel Syndrome and Static Magnetic Field Therapy

Resource links provided by NLM:


Further study details as provided by National College of Natural Medicine:

Primary Outcome Measures:
  • Boston Carpal Tunnel Questionnaire Symptom Severity Scale [ Time Frame: Baseline, Wks 2, 4, 6, 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Electrophysiological recovery of median nerve [ Time Frame: Baseline, 6 weeks, 18 weeks ] [ Designated as safety issue: Yes ]
  • 2. General symptom questionnaire [ Time Frame: Baseline and on completion of intervention phase ] [ Designated as safety issue: No ]
  • 3. Compliance with treatment [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Surface magnetic field strength at target 450 Gauss permanent magnet
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
Experimental: B
Surface field strength at target 150 Gauss 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
Active Comparator: C 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.

Detailed Description:

See Brief Summary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521495

Locations
United States, Oregon
National College of Natural Medicine
Portland, Oregon, United States, 97201
Sponsors and Collaborators
National College of Natural Medicine
Oregon Health and Science University
Investigators
Principal Investigator: Agatha P Colbert, MD National College of Natural Medicine
  More Information

No publications provided by National College of Natural Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agatha Colbert, Principal Investigator, National College of Natural Medicine
ClinicalTrials.gov Identifier: NCT00521495     History of Changes
Other Study ID Numbers: R21 AT003293, R21AT003293
Study First Received: August 24, 2007
Last Updated: November 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National College of Natural Medicine:
static magnetic field
permanent magnet
carpal tunnel syndrome
median nerve

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014