Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education

May 8, 2020 updated by: Kessler Foundation

Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI).

The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic pain (pain that is present for a long period of time) is common among people with spinal cord injury (SCI). The pain is often severe and can affect daily activities. Unfortunately, common treatments such as medications provide incomplete relief from chronic pain. Thus, persons with SCI have to find alternate ways to live a happy, healthy, and productive life, even with some pain.

The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • SCI for at least one year
  • Chronic pain for at least three months that is moderate to severe
  • Fluent in English
  • Not currently starting a new pain treatment or changing a previous pain treatment

Exclusion Criteria:

  • Lack of access to a computer with high-speed internet access, at home or another location
  • Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect 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 well
  • Other conditions not related to SCI that cause pain (such as fibromyalgia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web-Based Education Program Type 1
The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.
Other: Education Program Type 1
The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
Experimental: Web-Based Education Program Type 2
The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.
Other: Education Program Type 2
The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Time Frame: Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
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 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.
Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity rated on a 0-10 numerical rating scale
Time Frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Brief Patient Health Questionnaire scores
Time Frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Brief Patient Health Questionnaire will be used to assess changes in mental health before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Mental Health Subscale of the SF-36 scores
Time Frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Mental Health Subscale of the SF-36 will be used to assess changes in mental health and well-being before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Survey of Pain Attitudes scores
Time Frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Survey of Pain Attitudes will be used to assess thoughts and feelings about pain before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Coping Strategies Questionnaire scores
Time Frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Coping Strategies Questionnaire will be used to assess thoughts and feelings about pain before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Chronic Pain Acceptance Questionnaire scores
Time Frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Chronic Pain Acceptance Questionnaire will be used to assess thoughts and beliefs about pain before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
Time Frame: 3, 6, 12 months post-intervention 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 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.
3, 6, 12 months post-intervention versus baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

eMindful.com

Investigators

  • Principal Investigator: Jeanne M Zanca, PhD, MPT, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-860-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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