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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00965601
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : April 6, 2012
Information provided by:
Indiana University

Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Cognitive Behavioral Therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Study Start Date : July 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00965601

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United States, Indiana
National Institute of Fitness and Sport; IUPUI Campus
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Principal Investigator: Dennis C Ang, MD Indiana University Department of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dennis C. Ang, MD, Indiana University Identifier: NCT00965601    
Other Study ID Numbers: NFR 080554
IU Internally funded
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: August 2009
Keywords provided by Indiana University:
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases