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

NCT02561676 | Completed Phase 1

• 1 other identifier: R-860-14
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Spinal Cord Injuries

Keywords

Mindfulness; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline

• Change in Brief Patient Health Questionnaire scores

  Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline

• Change in Mental Health Subscale of the SF-36 scores

  Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline

• Change in Survey of Pain Attitudes scores

  Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline

• Change in Coping Strategies Questionnaire scores

  Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline

Study Arms (2)

Web-Based Education Program Type 1

EXPERIMENTAL

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.

Other: Education Program Type 1

Web-Based Education Program Type 2

EXPERIMENTAL

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.

Other: Education Program Type 2

Interventions

Education Program Type 1 OTHER

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.

Web-Based Education Program Type 1

Education Program Type 2 OTHER

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.

Web-Based Education Program Type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kessler Foundation: lead
• eMindful.com: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Chronic Pain; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jeanne M Zanca, PhD, MPT

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: September 28, 2015
• Study Start: March 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

US (1)