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Completed

NCT Number: NCT02561676

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

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.

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Key information

Conditions

Chronic Pain Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Education Program Type 1

Other

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.

Education Program Type 2

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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").

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • eMindful.com

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 28, 2015
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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