Short and Long Term Exposure to Unique, Time-Varying Pulsed Electro-Magnetic Fields in Refractory Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
Collaborator:
Dr. Steven P. Cole, PhD. Statistician
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:
NCT00277563
First received: January 13, 2006
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

Pulsed electromagnetic fields (PEMF) have been approved by FDA and are utilized currently in treating non-union fractures, neurogenic bladder and musculoskeletal pains. Based on 2 prior pilot studies (open label) demonstrating reduction in neuropathic pain from carpal tunnel syndrome we decided to perform a placebo-controlled trial, randomized for 2 months utilizing a wrist PEMF device attached by Velcro for 4 hours/day.


Condition Intervention Phase
Refractory Carpal Tunnel Syndrome
Neurpathic Pain
Neuromodulaton
Device: reduction of pain scores by magnetic energy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Short and Long Term Exposure to Unique, Time-Varying Pulsed Electro-Magnetic Fields in Refractory Carpal Tunnel Syndrome (Cts): A Randomized, Placebo-Controlled Trial With Secondary Bayesian Modification

Resource links provided by NLM:


Further study details as provided by Weintraub, Michael I., MD, FACP, FAAN:

Primary Outcome Measures:
  • VAS Pain scores 0-10 (leikert scale)
  • VAS Sleep interrupption 0-10
  • Neuropathic Pain scale (NPS)

Secondary Outcome Measures:
  • Neurological Exam
  • Median nerve distal latencies (CMAP/SNAP)
  • Hand help Dynamometry and Finger gauge pressures
  • CPT (Neurometer)
  • PGIC

Estimated Enrollment: 50
Study Start Date: June 2004
Estimated Study Completion Date: July 2005
Detailed Description:

INTRODUCTION:

Entrapment of the median nerve at the wrist is the most common cause of sensory and motor disturbance in the hands and can be progressively disabling.1,2 Complex mechanisms of compression and ischemia exist that adversely influence the large A myelinated fibers and small unmyelinated nociceptive C fibers. From a pathophysiological standpoint, neuropathic pain (numbness, tingling and burning, NP) is believed secondary to ectopic firing of nociceptive afferent unmyelinated C-fiber axons that are undergoing degeneration.3 Microneurography has confirmed that dysregulated expression of sodium and calcium channels, which accumulate at site of injury, are responsible for ectopic depolarization.3,4,53,54 When conventional therapy of splinting and pharmacotherapy fail, surgical decompression has been offered for moderate-severe cases. While usually successful, it is associated with significant complications, limitations and costs.5,6,7 Thus, the search for reliable and new therapeutic strategies is appealing.

Substantial evidence exists that time-varying magnetic fields produce biological effects by safely inducing extremely low-frequency (ELF) small electrical eddy currents within the tissues that can depolarize, repolarize and hyperpolarize neurons.8,9,10,11,12

Prior pilot data using static13 and pulsed magnetic fields (PEMF)14,15 directed to the carpal tunnel region significantly reduced NP. Since a new, novel device became commercially available that produced a combination of static and time-varying magnetic fields simultaneously, it was hypothesized that this energy could be directed into the wrists and potentially influence not only NP scores, but also modulate neuronal distal latencies (neurotransmission).

DEVICE:

DESCRIPTION: (FIGURE 1) This patented device (Biaxial Super Mini [Mx2R] by Nikken, Inc.) measures 2" in diameter and 1" in height and is worn with a Velcro strap similar to a wristwatch. It is noiseless and nonthermal. Its main component is a spherical permanent magnet, 1150G, 3/8" in diameter that rotates in two perpendicular directions simultaneously producing biaxial magnetic rotation (MX2R) and oscillating polarities up to 1,200 rpm-20 times per second. It is driven by a 2 V DC micro-motor which is shielded one inch away and produces a negligible back EMF. The device is powered by three ¼ AAA rechargeable NiMH (Nickel Metal Hydride) batteries

Randomized double blind placebo-controlled device with primary parameters of pain and sleep interupption scores, NPS scale and secondary parameters of neurological exam changes, nerve conduction latencies of median nerve, dynamometry, finger gauge pressures, CPT and PGIC were compared at baseline and end of two months. Patients were given a free "active" device gratis at end of study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intractable neuropathic pain in median nerve innervated hand for at least 3 months;
  • Abnormal neurological examination compatible with diagnosis of CTS

Exclusion Criteria:

  • Post-surgical failures,
  • Pregnancy,
  • Pts with pacemaker
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00277563

Locations
United States, New York
Michael I. Weintraub MD, PC
Briarcliff, New York, United States, 10510
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Dr. Steven P. Cole, PhD. Statistician
Investigators
Study Chair: Steven P. Cole, PhD statistician
  More Information

No publications provided by Weintraub, Michael I., MD, FACP, FAAN

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00277563     History of Changes
Other Study ID Numbers: 1-Weintraub
Study First Received: January 13, 2006
Last Updated: September 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Weintraub, Michael I., MD, FACP, FAAN:
Carpal Tunnel Syndrome
Neuropathic Pain
Neuromodulation
PEMF
Magnetic Field Therapy
Magnetotherapy

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 July 24, 2014