NCT00277563

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
Last Updated

September 21, 2007

Status Verified

September 1, 2007

First QC Date

January 13, 2006

Last Update Submit

September 20, 2007

Conditions

Refractory Carpal Tunnel SyndromeNeurpathic PainNeuromodulaton

Keywords

Carpal Tunnel SyndromeNeuropathic PainNeuromodulationPEMFMagnetic Field TherapyMagnetotherapy

Outcome Measures

Primary Outcomes (3)

  • VAS Pain scores 0-10 (leikert scale)

  • VAS Sleep interrupption 0-10

  • Neuropathic Pain scale (NPS)

Secondary Outcomes (5)

  • Neurological Exam

  • Median nerve distal latencies (CMAP/SNAP)

  • Hand help Dynamometry and Finger gauge pressures

  • CPT (Neurometer)

  • PGIC

Interventions

reduction of pain scores by magnetic energyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Post-surgical failures,
  • Pregnancy,
  • Pts with pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael I. Weintraub MD, PC

Briarcliff, New York, 10510, United States

Location

Related Publications (1)

  • Weintraub MI, Cole SP. A randomized controlled trial of the effects of a combination of static and dynamic magnetic fields on carpal tunnel syndrome. Pain Med. 2008 Jul-Aug;9(5):493-504. doi: 10.1111/j.1526-4637.2007.00324.x.

    PMID: 18777606DERIVED

MeSH Terms

Conditions

Carpal Tunnel SyndromeNeuralgia

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven P. Cole, PhD

    Statistician

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

June 1, 2004

Study Completion

July 1, 2005

Last Updated

September 21, 2007

Record last verified: 2007-09

Locations

US(1)