Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

October 3, 2008 updated by: Fralex Therapeutics

Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia

This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Ottawa, Ontario, Canada, K1H 1A2
      • Toronto, Ontario, Canada, M9W 4L6
      • Toronto, Ontario, Canada, M2N 6K7
  • United States
    • California
      • Encinitas, California, United States, 92024
      • Garden Grove, California, United States, 92845
      • La Jolla, California, United States, 92037
      • Lancaster, California, United States, 93534
      • Murrieta, California, United States, 92563
      • Palmdale, California, United States, 93550
    • Florida
      • Gainsville, Florida, United States, 32610
      • West Palm Beach, Florida, United States, 33409
      • Winter Park, Florida, United States, 32789
    • Kentucky
      • Lexington, Kentucky, United States, 40503
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10003
      • Rochester, New York, United States, 14642-8604
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
    • Washington
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic musculoskeletal pain of at least six months duration secondary to FMS using American College of Rheumatology (ACR) criteria and with the minimum of 11 of 18 defined tender points, measured by dolorimeter at a threshold of up to 4 kg of pressure
  • Males and females, 18 years and older
  • Able to complete assessment index forms unaided by caregiver/interpreter
  • Pain score of 4 or greater on the Numerical Rating Scale (NRS), averaged from the Baseline Period scores recorded on the 7 days immediately prior to randomization
  • Demonstration of stabilized pain scores as measured on the NRS during the Baseline Period (Days -7 to -1)
  • Able to tolerate prohibition of all medications for pain, depression and sleep disorders except for acetaminophen (up to 4 g/day) and cardiac aspirin (up to 325 mg/day) demonstrated for the Stabilization and Baseline Periods prior to randomization
  • Able and willing to provide a written informed consent

Exclusion Criteria:

  • Unwilling or unable to sign an informed consent, or to comply with the protocol
  • Evidence of inflammatory rheumatic disease, secondary fibromyalgia, or other severe painful disorders that might confound assessment of FMS pain
  • Currently under treatment (pharmacological or cognitive therapy) for a Major Depressive Episode (MDE) or has demonstrated suicidal ideation in the past
  • History or current treatment of migraine, tension or cluster headache requiring regular medication
  • History or current treatment of seizure disorder
  • History or current treatment of cancer with the exception of basal cell carcinoma and cervical dysplasia
  • Cognitive dysfunction or personality disorder which would preclude self-directed treatment, self assessment and / or diary completion
  • Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation
  • Hearing aids, metal implants (excludes dental work) above mid torso or in the cranium (e.g. plates, implants or clips). (Metal implants in parts of the body below mid-torso, such as knee or hips replacements, clips, screws or plates to stabilize fractures are acceptable)
  • Pacemakers, defibrillators, implanted neurostimulators, implanted drug pumps or other electrical implanted devices
  • Insufficient knowledge of English to complete the self-assessment forms
  • History of or current drug or alcohol abuse
  • History of abuse of a previous physician relationship or the medical system
  • Receiving disability insurance, applying for disability insurance, or engaged in litigation related to FMS
  • Use of an investigational drug or device in a controlled study within 30 days
  • Pregnancy (U.S. sites only)
  • Breastfeeding or intending to breastfeed (U.S. sites only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinically significant pain reduction, evidenced by a statistically significant difference between active and placebo groups in percentage of subjects who achieve a pain reduction of at least 30% at week 12 as compared to the Baseline.

Secondary Outcome Measures

Outcome Measure
Additional outcome measures will include mood alteration, sleep quality, improvement of physical functioning and relief medication usage by subjects in both groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fralex Therapeutics

Collaborators

PharmaNet
McDougall Scientific Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 21, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F06001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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