Clinical trial NCT02262234: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Chronic Pain
Keywords: Spinal cord injury
Chronic pain
Education
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
name: Kessler Institute for Rehabilitation
First posted: 2014-10-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain interference with activities
timeFrame: Week 10 versus baseline
Secondary outcomes:
measure: Pain intensity
timeFrame: Week 10 versus baseline
measure: Mental health and well-being
timeFrame: Week 10 versus baseline
measure: Pain attitudes
timeFrame: Week 10 versus baseline
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Jeanne M Zanca, PhD, MPT
role: PRINCIPAL_INVESTIGATOR
References: