A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia (NFR)

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00965601
First received: August 24, 2009
Last updated: April 5, 2012
Last verified: August 2009
  Purpose

The investigators are doing this study to better understand the role of the central nervous system in processing painful stimuli in patients with fibromyalgia. Specifically, the investigators would like to know whether the central nervous system processing of painful stimuli changes with time and with talk therapy. In addition, the investigators are investigating how changes in your fibromyalgia symptoms may affect certain markers or proteins in your blood.


Condition Intervention Phase
Fibromyalgia
Behavioral: Cognitive Behavioral Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity. [ Time Frame: Baseline, Week 9, and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aim 2: Determine the longitudinal relationships of changes in patients' symptoms with changes in plasma levels of neuropeptides and NFR pain threshold. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CTB Group
Subjects will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)
Behavioral: Cognitive Behavioral Therapy
Subjects randomized to the Active Arm will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)
No Intervention: Usual Care
Subjects will not receive any type of intervention

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • 1. Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist.
  • 2. Overall body pain average score ≥ 4
  • 3. Age range: 18 to 65 years old
  • 4. You must be on stable doses of anyone of these fibromyalgia-related medications for at least 4 weeks: cyclobenzaprine, tramadol, gabapentin, pregabalin, amitriptyline, nortriptyline, trazodone, sertraline, fluoxetine, paxil, remeron, venlafaxine and duloxetine.
  • 5. Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks.

Exclusion Criteria:

  • 1. Volunteers who have long-standing history of diabetes (> 2 years), or have been diagnosed with any type of peripheral neuropathy.
  • 2. Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias.
  • 3. Have been diagnosed with multiple sclerosis or any other demyelinating disorder.
  • 4. Have planned to undergo an elective surgery over the next 12 weeks.
  • 5. Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)
  • 6. Are currently pregnant or actively trying to become pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965601

Locations
United States, Indiana
National Institute of Fitness and Sport; IUPUI Campus
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Dennis C Ang, MD Indiana University Department of Medicine
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dennis C. Ang, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00965601     History of Changes
Other Study ID Numbers: NFR 080554, IU Internally funded
Study First Received: August 24, 2009
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
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 April 17, 2014