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NCT Number: NCT02262234

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Chronic Pain 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

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Education Program Type 1

Other

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.

Education Program Type 2

Other

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 outcomes

  1. 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

  1. Pain intensity

    Time frame: Week 10 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. Mental health and well-being

    Time frame: Week 10 versus baseline

    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.

  3. Pain attitudes

    Time frame: Week 10 versus baseline

    The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Kessler Institute for Rehabilitation
  • The Craig H. Neilsen Foundation

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 13, 2014
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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