Power Over Pain (POP) Study
POP
Psychological Treatment of Disability-Related Pain: Efficacy and Mechanisms
2 other identifiers
interventional
177
1 country
1
Brief Summary
Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been little research on how to treat this pain. Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person thinks about his/her pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these different treatments can help decrease pain in people with multiple sclerosis and spinal cord injury, and determine how and why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD, or LBP, have chronic pain, and be at least 18 years old to participate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Feb 2013
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedOctober 17, 2018
October 1, 2018
4.9 years
February 8, 2013
October 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in average pain intensity pre-treatment to post-treatment
Average pain intensity will be assessed via telephone interviews using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, four times within a 1-week period at each assessment point. The change in mean of these ratings will be used as the primary outcome measure of average daily pain intensity.
Pre-treatment, Mid-treatment, Post-treatment, 3-,6-, and 12 months following end of treatment.
Study Arms (4)
Pain Self-Management Arm #1
EXPERIMENTALPain Self-Management Intervention #1
Pain Self-Management Arm #2
EXPERIMENTALPain Self-Management Intervention #2
Pain Self-Management Arm #3
EXPERIMENTALPain Self-Management Intervention #3
Pain Self-Management Arm #4
EXPERIMENTALPain Self-Management Intervention #4
Interventions
Pain Self-Management Intervention #1 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain. Participants will be encouraged to ask questions about and discuss the information presented during the treatment sessions.
Pain Self-Management Intervention #2 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). Pain Self-Management Intervention #2 will emphasize cognitive restructuring skills to replace maladaptive pain-related thoughts with adaptive and reassuring ones. These skills include being able to: (1) develop awareness of one's thoughts; (2) identify and evaluate adaptive/helpful vs. unhelpful/maladaptive thoughts; and (3) develop alternative thoughts to maladaptive thoughts that are (a) realistic, (b) accurate, (c) reassuring, and (d) facilitate positive outcomes.
Pain Self-Management Intervention #3 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). In Pain Self-Management Intervention #3, subjects will relax in a comfortable position with their eyes closed and simply listen to the clinician speak. The clinician will begin the session with a hypnotic induction focusing on being aware of sensations of relaxation, followed by suggestions for decreases in pain intensity and alterations in the sensory experience of "what are sometimes uncomfortable sensations" so that they are more comfortable.
Pain Self-Management Intervention #4 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). Pain Self-Management Intervention #4 will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into a participant's belief system.
Eligibility Criteria
You may qualify if:
- years of age or older;
- diagnosis of SCI, MS, AMP, MD or LBP
- moderate to severe chronic pain possibly related to MS, SCI, AMP, MD, or LBP that is persistent in nature;
- able to read, speak, and understand English.
You may not qualify if:
- severe cognitive impairment defined as two or more errors on the Six-Item Screen;
- psychiatric condition or symptoms that would interfere with participation;
- Pre-existing medical conditions that might interfere with EEG assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington, Ninth and Jefferson Building
Seattle, Washington, 98104, United States
Related Publications (1)
de la Vega R, Sakulsriprasert P, Miro J, Jensen MP. Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden? J Pain. 2024 Jul;25(7):104474. doi: 10.1016/j.jpain.2024.01.339. Epub 2024 Jan 15.
PMID: 38232864DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Jensen, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Rehabilitative Medicine
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 27, 2013
Study Start
February 1, 2013
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
October 17, 2018
Record last verified: 2018-10