Clinical trial NCT02561676: Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
Official title: Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pain
Spinal Cord Injuries
Keywords: Mindfulness
Spinal Cord Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: eMindful.com
First posted: 2015-09-28
Enrollment: 75
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).

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
timeFrame: 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 outcomes:
measure: Change in pain intensity rated on a 0-10 numerical rating scale
timeFrame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
measure: Change in Brief Patient Health Questionnaire scores
timeFrame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
measure: Change in Mental Health Subscale of the SF-36 scores
timeFrame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
measure: Change in Survey of Pain Attitudes scores
timeFrame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
measure: Change in Coping Strategies Questionnaire scores
timeFrame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
measure: Change in Chronic Pain Acceptance Questionnaire scores
timeFrame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
measure: Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
timeFrame: 3, 6, 12 months post-intervention 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: