Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

This study has been terminated.
Sponsor:
Collaborators:
PharmaNet
McDougall Scientific Limited
Information provided by:
Fralex Therapeutics
ClinicalTrials.gov Identifier:
NCT00450905
First received: March 21, 2007
Last updated: October 3, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Pain
Device: PRIMA Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Fralex Therapeutics:

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

Estimated Enrollment: 200
Study Start Date: March 2007
Estimated Study Completion Date: December 2008
  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450905

Locations
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
United States, Florida
Gainsville, Florida, United States, 32610
West Palm Beach, Florida, United States, 33409
Winter Park, Florida, United States, 32789
United States, Kentucky
Lexington, Kentucky, United States, 40503
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
New York, New York, United States, 10003
Rochester, New York, United States, 14642-8604
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99216
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Ottawa, Ontario, Canada, K1H 1A2
Toronto, Ontario, Canada, M9W 4L6
Toronto, Ontario, Canada, M2N 6K7
Sponsors and Collaborators
Fralex Therapeutics
PharmaNet
McDougall Scientific Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00450905     History of Changes
Other Study ID Numbers: F06001
Study First Received: March 21, 2007
Last Updated: October 3, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Fralex Therapeutics:
Chronic musculoskeletal pain secondary to Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014