NCT00823147

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

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

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 6, 2019

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

January 13, 2009

Last Update Submit

August 5, 2019

Conditions

Musculoskeletal Pain

Keywords

PainSystemic InflammationPain Catastrophizing

Outcome Measures

Primary Outcomes (2)

  • Change in pro-inflammatory cytokine levels assessed from immunoassay samples

    3.5 hours

  • Change in anti-inflammatory cytokine levels assessed from immunoassay samples

    3.5 hours

Study Arms (2)

Pain Catastrophizing Induction Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Pain Catastrophizing InductionBEHAVIORAL

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.

Pain Catastrophizing Induction Group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women between the ages 18-70
  • Non-smokers
  • Diagnosed with musculoskeletal chronic pain
  • Normal menstrual cycle or postmenopausal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science Universtiy

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Musculoskeletal PainPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Beth Darnall, Ph.D

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2012

Study Completion

September 1, 2014

Last Updated

August 6, 2019

Record last verified: 2019-07

Locations

US(1)