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Clinical Trials/NCT02262234
NCT02262234
Completed
Phase 1

Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study

Kessler Foundation1 site in 1 country29 target enrollmentSeptember 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
Kessler Foundation
Enrollment
29
Locations
1
Primary Endpoint
Pain interference with activities
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI must find ways of accomplishing daily activities even though they have pain.

The purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.

Detailed Description

Pain is a highly prevalent and disabling condition among persons with spinal cord injury (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects, and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual pain and pain-related disability are greatly needed. A number of research studies have associated educational interventions with improvements in pain-related outcomes. The overall goal of the proposed pilot study is to evaluate the feasibility, acceptability, and potential benefits of two types of educational programs for people with chronic pain and spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that empowers people with pain and SCI to improve their functioning and quality of life.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Spinal cord injury for at least one year
  • Chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine")
  • Fluent in English
  • Not currently starting a new pain treatment or changing a previous pain treatment

Exclusion Criteria

  • Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect my physical or mental functioning
  • Significant difficulties with learning or memory
  • Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
  • Inability to understand English
  • Presence of other conditions not related to SCI that cause pain (such as fibromyalgia)

Outcomes

Primary Outcomes

Pain interference with activities

Time Frame: Week 10 versus baseline

The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a 10-item self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.

Secondary Outcomes

  • Pain attitudes(Week 10 versus baseline)
  • Pain intensity(Week 10 versus baseline)
  • Mental health and well-being(Week 10 versus baseline)

Study Sites (1)

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