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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Education Program Type 1

Education Program Type 2

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Mindfulness, Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Web-Based Education Program Type 1

Web-Based Education Program Type 2

Arm Description

The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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").

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02561676

First Posted

February 11, 2015

Last Updated

May 8, 2020

Sponsor

Kessler Foundation

Collaborators

eMindful.com

1. Study Identification

Unique Protocol Identification Number

NCT02561676

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kessler Foundation

Collaborators

eMindful.com

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Spinal Cord Injuries

Keywords

Mindfulness, Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Web-Based Education Program Type 1

Arm Type

Experimental

Arm Description

The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.

Arm Title

Web-Based Education Program Type 2

Arm Type

Experimental

Arm Description

The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.

Intervention Type

Other

Intervention Name(s)

Education Program Type 1

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Education Program Type 2

Intervention Description

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 Outcome Measure Information:

Title

Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)

Description

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.

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)

Secondary Outcome Measure Information:

Title

Change in pain intensity rated on a 0-10 numerical rating scale

Description

Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").

Time Frame