Power Over Pain (POP) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mark Jensen, University of Washington
ClinicalTrials.gov Identifier:
NCT01800604
First received: February 8, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

Many individuals with multiple sclerosis (MS) and spinal cord injury (SCI) 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 or SCI, have chronic pain, and be at least 18 years old to participate.


Condition Intervention
Multiple Sclerosis
Spinal Cord Injury
Chronic Pain
Behavioral: Pain Self-Management Intervention #1
Behavioral: Pain Self-Management Intervention #2
Behavioral: Pain Self-Management Intervention #3
Behavioral: Pain Self-Management Intervention #4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Treatment of Disability-Related Pain: Efficacy and Mechanisms

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in average pain intensity pre-treatment to post-treatment [ Time Frame: Pre-treatment, Mid-treatment, Post-treatment, 3-,6-, and 12 months following end of treatment. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 144
Study Start Date: February 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain Self-Management Arm #1
Pain Self-Management Intervention #1
Behavioral: Pain Self-Management Intervention #1
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.
Experimental: Pain Self-Management Arm #2
Pain Self-Management Intervention #2
Behavioral: Pain Self-Management Intervention #2
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.
Experimental: Pain Self-Management Arm #3
Pain Self-Management Intervention #3
Behavioral: Pain Self-Management Intervention #3
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.
Experimental: Pain Self-Management Arm #4
Pain Self-Management Intervention #4
Behavioral: Pain Self-Management Intervention #4
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. diagnosis of SCI or MS as verified either by a) medical record review; b) presence of appropriate diagnostic code for MS or SCI on coding list from UWMC's Center for Clinical Excellence or HMC's Decision Support; or c) verification confirmed by subject's physician.
  3. experiences pain that may be related to MS or SCI diagnosis;
  4. chronic pain possibly related to MS or SCI has lasted 6 months or more;
  5. pain problem either started or has become worse since SCI or onset of MS symptoms;
  6. average pain intensity rating (all pain problems) of ≥ 4 on a 0-10 NRS of pain intensity in the last week;
  7. Experienced pain at least half the days in the past four weeks; and
  8. able to read, speak, and understand English.

Exclusion Criteria:

  1. severe cognitive impairment defined as one or more errors on the Six-Item Screen;
  2. psychiatric condition or symptoms that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking;
  3. history of a medical condition that could produce an abnormal EEG and interfere with the tests of the effects of treatment on EEG (e.g., epilepsy, history of traumatic brain injury that involved a loss of consciousness for longer than 24 hours); and
  4. Permanent braiding, dreadlocks, hairpieces, metal plates, or missing portions beneath the scalp.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800604

Contacts
Contact: Holly George, B.A. 206-616-8205 hrgeorge@uw.edu
Contact: Linea Johnson, B.A. 206-616-7671 lineaj@uw.edu

Locations
United States, Washington
University of Washington, Ninth and Jefferson Building Recruiting
Seattle, Washington, United States, 98104
Contact: Kevin Gertz, MPA    206-616-8630    kjgertz@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Mark Jensen, PhD University of Washington
  More Information

No publications provided

Responsible Party: Mark Jensen, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01800604     History of Changes
Other Study ID Numbers: 43605-G, 1R01HD070973
Study First Received: February 8, 2013
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Multiple Sclerosis
Spinal Cord Injuries
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Central Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014