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

Primary Purpose

Spinal Cord Injury, Chronic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Education Program Type 1
Education Program Type 2
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Chronic pain, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Education Program Type 1

Education Program Type 2

Arm Description

Outcomes

Primary Outcome Measures

Pain interference with activities
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 Outcome Measures

Pain intensity
Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
Mental health and well-being
The Brief Patient Health Questionnaire and Perceived Stress Scale will be used to assess changes in mental health that occur between baseline and the end of the education program.
Pain attitudes
The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.

Full Information

First Posted
October 7, 2014
Last Updated
May 8, 2020
Sponsor
Kessler Foundation
Collaborators
The Craig H. Neilsen Foundation, Kessler Institute for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT02262234
Brief Title
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
Official Title
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
The Craig H. Neilsen Foundation, Kessler Institute for Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Chronic Pain
Keywords
Spinal cord injury, Chronic pain, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Program Type 1
Arm Type
Experimental
Arm Title
Education Program Type 2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Education Program Type 1
Intervention Description
The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
Intervention Type
Other
Intervention Name(s)
Education Program Type 2
Intervention Description
The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
Primary Outcome Measure Information:
Title
Pain interference with activities
Description
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.
Time Frame
Week 10 versus baseline
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
Time Frame
Week 10 versus baseline
Title
Mental health and well-being
Description
The Brief Patient Health Questionnaire and Perceived Stress Scale will be used to assess changes in mental health that occur between baseline and the end of the education program.
Time Frame
Week 10 versus baseline
Title
Pain attitudes
Description
The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.
Time Frame
Week 10 versus baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne M Zanca, PhD, MPT
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Links:
URL
http://KesslerFoundation.org
Description
Kessler Foundation Home Page

Learn more about this trial

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

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