Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Chronic pain is an international health problem that imposes costs of over 600 billion dollars per year. This study focuses on fibromyalgia (FM), which is characterized by persistent, widespread body pain, with significant evidence of altered brain function. One of the few effective treatments for FM is cognitive-behavioral therapy (CBT), which has been shown to reduce pain intensity and pain-related disability, potentially via reductions in catastrophizing, an important psychosocial factor that plays a crucial role in shaping individual differences in pain-related outcomes. The investigator’s previous study in FM patients confirmed that patients who are high in catastrophizing show enhanced pain-related activation in brain areas that process emotional aspects of pain (e.g., anterior insula and medial thalamus). In addition, catastrophizing was associated with altered pain-evoked functional connectivity between thalamus, anterior insula, and default mode network (DMN) structures such as medial prefrontal cortex.

This study hypothesizes that CBT-produced improvements in pain will be anticipated and mediated by reductions in catastrophizing and their associated effects on pain-related brain functioning. The two components of the study include 1) a cross-sectional assessment of brain connectivity and response to pain in healthy controls and demographically matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either CBT (Cognitive Behavioral Therapy) or a Disease Education condition. The overarching goal is to understand the neurobiological pathways by which CBT and reduced catastrophizing facilitate improvements in chronic pain; such information will help to refine biopsychosocial models of pain, identify potential non-responders early in treatment, and facilitate the enhancement of psychosocial interventions for chronic musculoskeletal pain.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           18 Years to 65 Years   (Adult, Older Adult)

Sexes Eligible for Study:          Female

Accepts Healthy Volunteers:  Yes

Inclusion Criteria:

Inclusion Criteria for FM patients:

  • aged 18-65
  • female
  • have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia
  • on stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
  • right-handed
  • baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
  • able to provide written consent. 

Inclusion Criteria for Healthy Control Participants

  • aged 18-65
  • female
  • right-handed
  • able to provide written consent 

Exclusion Criteria:

Exclusion Criteria for FM:

  • comorbid acute pain condition
  • comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
  • current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
  • Routine or daily use of narcotics, marijuana or substances of abuse
  • Certain condition that intervene with Quantitative Sensory Testing (QST) and/or fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or/and any impairment, activity or situation that could prevent satisfactory completion of the study protocol (e.g unreliable, or inconsistent pain scores). 

Exclusion criteria for Healthy Control Participants:

  • any acute or chronic pain condition (e.g., FM, arthritis)
  • current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
  • Routine or daily use of narcotics, marijuana or substances of abuse
  • Certain condition that intervene with Quantitative Sensory Testing (QST) and fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or any impairment, activity or situation would prevent satisfactory completion of the study protocol (e.g unreliable, or inconsistent pain scores). This includes unreliable, or inconsistent pain scores as deemed by the principal investigator. 

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Double (Investigator, Outcomes Assessor)

Primary Purpose: Other

Study Location(s):

Massachusetts General Hospital, Charlestown, Massachusetts, United States, 02129

Brigham and Women's Hospital, Chestnut Hill, Massachusetts, United States, 02467

Study Website:

https://clinicaltrials.gov/ct2/show/NCT01345344?term=NCT01345344&rank=1

Last Updated: August 2019