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Pain Catastrophizing as a Cause for Systemic Inflammation

This study is currently recruiting participants.
Verified September 2009 by Oregon Health and Science University
Sponsor:
Collaborators:
Oregon Clinical and Translational Research Institute
Office of Research on Women's Health (ORWH)
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00823147
First received: January 13, 2009
Last updated: September 11, 2009
Last verified: September 2009
History of Changes
  Purpose

Research shows that the immune system is involved in chronic pain. The immune system is involved in the process of inflammation. The investigators are still learning about the factors that cause inflammation, but know it can be measured in the blood. The purpose of this study is to understand how negative thoughts affect the immune system in women with chronic pain.

A sub-study asks subjects to store a blood sample for future research by the PI aimed at identifying genetic markers in women with chronic pain.


Condition Intervention
Chronic Musculoskeletal Pain
 Behavioral: Pain Catastrophizing Induction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pain Catastrophizing as a Cause for Systemic Inflammation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Pro-inflammatory and anti-inflammatory cytokine responses [ Time Frame: Study visit day only; measured at baseline, 1.5 hours, 2.5 hours, 3.5 hours, 4.5 hours ] [ Designated as safety issue: No ]
  • Baseline measurement for mood, function, pain intensity, anxiety, and sleep quality [ Time Frame: Measured at baseline on study visit day. Pain intensity is tracked across the study day (baseline, 15 minutes, 1.5 hours, 2.5 hours, 3.5 hours, 4.5 hours). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in mood, function, and pain intensity across time [ Time Frame: These outcomes refer to the longitudinal portion of the study. In addition to measuring these outcomes on the study day as described above, we will be measuring these outcomes at 6-month intervals for up to 10 years. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole Blood, saliva


Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pain Catastrophizing Induction Group

Collect salivary cortisol kit if subject did not mail from home Full battery of self-report measures given. Pain ratings taken (0-10). Height and weight measured. Heart monitor affixed. Catheter placed; 25 minute rest.

Catastrophizing group: 10-minute catastrophizing induction. Participants self-rate their level of emotional distress.

Subsequent blood draws occur per protocol time points:

  1. 25 minutes following IV placement (BASELINE)
  2. 15 minutes post catastrophizing induction (stress experiment)
  3. 90 minutes (1.5 hours) post-induction
  4. 150 minutes (2.5 hours) post-induction
  5. 210 minutes (3.5 hours) post-induction
  6. 270 minutes (4.5 hours) post-induction
 Behavioral: Pain Catastrophizing Induction
Participants will undergo a psychologist-guided 10-minute induction of negative cognitive focus on the theoretical future worsening of one's pain condition.Biological stress response will be measured via heart rate, blood pressure and serum cortisol.
Control Group

Collect salivary cortisol kit if subject did not mail from home Full battery of self-report measures given. Pain ratings taken (0-10). Height and weight measured. Heart monitor affixed. Catheter placed; 25 minute rest.

Control group: Persons in this group will rest, complete puzzles, read emotionally-neutral material or watch videos provided to them.

Blood draws and saliva samples gathered per protocol time points:

  1. 25 minutes following IV placement (BASELINE- T1)
  2. 25 minutes following baseline T2
  3. 115 minutes (1 hour 55 min) post baseline T3
  4. 175 minutes (2 hours 55 min) post baseline T4
  5. 235 minutes (3 hours 55 min) post baseline T5
  6. 295 minutes (4 hours 55 min) post baseline T6

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will be 60 women between the age of 18 and 45 having chronic musculoskeletal pain

Criteria

Inclusion Criteria:

  • Women between the ages 18-45
  • Non-smokers
  • Diagnosed with musculoskeletal chronic pain
  • Normal menstrual cycle

Exclusion Criteria:

  • Psychosis or suicidality
  • Current Major Depression
  • Former intravenous drug user
  • Needle/blood/injection phobia
  • Limited venous access
  • Sex-steroid dysregulation
  • Self-Reported Pregnancy
  • Fibromyalgia or inflammatory disease, e.g. lupus
  • Active corticosteroid regimen
  • Taking beta blockers
  • Taking oral contraception or hormone therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823147

Contacts
Contact: Beth Darnall, Ph.D 503 494 4351 darnallb@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science Universtiy Recruiting
Portland, Oregon, United States, 97239
Contact: Beth Darnall, Ph.D     503-494-4351     darnallb@ohsu.edu    
Contact: Kathy Parker, MSN     503-494-5224     parkerk@ohsu.edu    
Principal Investigator: Beth Darnall, Ph.D            
Sponsors and Collaborators
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Office of Research on Women's Health (ORWH)
Investigators
Principal Investigator: Beth Darnall, Ph.D Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Beth Darnall, Ph.D., Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00823147     History of Changes
Other Study ID Numbers: 4920, 5 K12 HD04348807
Study First Received: January 13, 2009
Last Updated: September 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Pain
Systemic Inflammation
Pain Catastrophizing

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013