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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561676
• Other study ID #: R-860-14
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	eMindful.com

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)	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	Change in pain intensity rated on a 0-10 numerical rating scale	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
Secondary	Change in Brief Patient Health Questionnaire scores	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
Secondary	Change in Mental Health Subscale of the SF-36 scores	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
Secondary	Change in Survey of Pain Attitudes scores	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
Secondary	Change in Coping Strategies Questionnaire scores	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
Secondary	Change in Chronic Pain Acceptance Questionnaire scores	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
Secondary	Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores	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