NCT00965601

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
Last Updated

April 6, 2012

Status Verified

August 1, 2009

Enrollment Period

1 year

First QC Date

August 24, 2009

Last Update Submit

April 5, 2012

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity.

    Baseline, Week 9, and Week 12

Secondary Outcomes (1)

  • Aim 2: Determine the longitudinal relationships of changes in patients' symptoms with changes in plasma levels of neuropeptides and NFR pain threshold.

    Baseline

Study Arms (2)

CTB Group

ACTIVE COMPARATOR

Subjects will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)

Behavioral: Cognitive Behavioral Therapy

Usual Care

NO INTERVENTION

Subjects will not receive any type of intervention

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Subjects randomized to the Active Arm will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)

CTB Group

Eligibility Criteria

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

You may qualify if:

  • \. Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist.
  • \. Overall body pain average score ≥ 4
  • \. Age range: 18 to 65 years old
  • \. 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.
  • \. Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks.

You may not qualify if:

  • \. Volunteers who have long-standing history of diabetes (\> 2 years), or have been diagnosed with any type of peripheral neuropathy.
  • \. Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias.
  • \. Have been diagnosed with multiple sclerosis or any other demyelinating disorder.
  • \. Have planned to undergo an elective surgery over the next 12 weeks.
  • \. Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)
  • \. Are currently pregnant or actively trying to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Fitness and Sport; IUPUI Campus

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Ang DC, Chakr R, Mazzuca S, France CR, Steiner J, Stump T. Cognitive-behavioral therapy attenuates nociceptive responding in patients with fibromyalgia: a pilot study. Arthritis Care Res (Hoboken). 2010 May;62(5):618-23. doi: 10.1002/acr.20119.

    PMID: 20191481DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dennis C Ang, MD

    Indiana University Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

April 6, 2012

Record last verified: 2009-08

Locations

US(1)