eHealth Program for Chronic Pain in Spinal Cord Injury

Overseen By Anna Kratz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Inpatient care, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called My SCI Toolkit, designed to help people with chronic pain from spinal cord injury. Researchers aim to determine if using this program, with or without a coach, improves pain management compared to usual treatment methods. Suitable participants include adults with a spinal cord injury who have experienced significant pain over the last three months, can read English, have internet access, and are willing to keep their pain medications stable during the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management solutions for spinal cord injury.

Will I have to stop taking my current medications?

The trial requires participants to keep their current pain medication routine stable during the study.

What prior data suggests that the My SCI Toolkit program is safe for individuals with spinal cord injury?

Research shows that the My SCI Toolkit program helps people manage chronic pain from spinal cord injuries. This program uses a self-management approach, empowering individuals to take charge of their own pain relief. It involves little risk because it doesn't rely on medication or surgery.

Studies on similar pain management programs have found that participants generally receive them well. Most people do not report negative side effects. Instead, they often find these programs helpful and easy to follow. The main focus is on understanding pain and learning ways to cope with it.

In summary, based on past research of similar programs, the My SCI Toolkit program appears to be a safe option for managing chronic pain in people with spinal cord injuries. Participants are likely to find it easy to use, and it should not cause harm or discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the My SCI Toolkit program because it offers a fresh approach to managing chronic pain in individuals with spinal cord injuries. Unlike traditional treatments that often rely on medications, this program provides a digital, interactive platform that empowers users to manage their pain through self-guided strategies. The My SCI Toolkit is accessible anytime and anywhere, making it a convenient option for users who need flexible solutions. Additionally, the program is available in two formats: unguided use for independent users and a coached version for those who benefit from personalized guidance, offering adaptable support based on individual needs. This versatility and emphasis on self-management make it a promising alternative to existing treatment options.

What evidence suggests that the My SCI Toolkit program is effective for chronic pain in spinal cord injury?

Research shows that self-management programs can help people with spinal cord injuries manage chronic pain more effectively. In this trial, participants will use the My SCI Toolkit program either independently or with coaching support. The My SCI Toolkit is a new online tool designed to assist individuals with spinal cord injuries in managing pain. Studies have found that similar programs, particularly those involving a coach, can enhance pain management. Participants in these programs often report improved pain handling and a better quality of life. Having a coach may make the program more effective than using it alone. ^{1 2 3 6 7}

Who Is on the Research Team?

Anna Kratz, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with chronic pain due to spinal cord injury who can use the internet and speak English. They should have had an average pain level of at least 4 out of 10 over the past three months but not be in intensive therapy or have significant cognitive impairment.

Inclusion Criteria

Willingness to maintain stable analgesic regimen during study period

Access to internet connected device (phone, tablet, computer) and telephone

I can read and understand English at a 6th grade level.

Exclusion Criteria

I am currently receiving care in a hospital or intensive outpatient therapy.

You have noticeable problems with memory and thinking, as shown by a simple test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either unguided or coached use of the My SCI Toolkit program or a wait-list control group for an 8-week study period

8 weeks

Weekly online surveys

Follow-up

Participants are monitored for changes in pain interference and satisfaction post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• My SCI Toolkit program

Trial Overview The study tests an eHealth program called My SCI Toolkit, offered both with a coach's support and without guidance, against usual treatment. It aims to see if having a coach improves adherence, satisfaction, and reduces pain interference more than unguided use or waiting for treatment.

How Is the Trial Designed?

Group I: Unguided use of the My SCI Toolkit program Experimental Treatment 1 Intervention

Group II: Coached My SCI Toolkit Experimental Treatment 1 Intervention

Group III: Wait-list control Active Control 1 Intervention

Participants will not access the My SCI Toolkit program during the 8-week study period and will be asked to continue daily life, including management of pain, as usual.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Published Research Related to This Trial

Stakeholder feedback from 75 participants, including individuals with spinal cord injuries and their caregivers, highlighted the importance of creating a user-friendly mobile app that promotes self-management skills to prevent secondary complications after discharge from rehabilitation.

The app's design focuses on individualization, goal-setting for self-management, and encouraging community participation, which are crucial for effective lifestyle changes and integration into the community post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Self-Management App for People with Spinal Cord Injury. Mortenson, WB., Singh, G., MacGillivray, M., et al.[2020]

Citations

1. scireproject.com scireproject.com/wp-content/uploads/2022/04/Pain_Toolkit_Printable-1.pdf

Pain Assessment Across Canada, RHSCIR is collecting comprehensive SCI data for the purpose of improving spinal cord injury (SCI) care and clinical outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07212725

Solving SCI Pain: Pain Recovery Tools for SCI Solving SCI Pain Tools is a 7-week, peer-led, neuroscience-informed pain self-management program uniquely designed for individuals with spinal ...

3. nature.com nature.com/articles/s41393-024-01033-1

The spinal cord injury (SCI) peer support evaluation tool The purpose of this study was to develop and test a spinal cord injury (SCI) peer support evaluation tool that meets the needs of community-based SCI ...

4. withpower.com withpower.com/trial/phase-spinal-cord-injuries-9-2023-d1380

eHealth Program for Chronic Pain in Spinal Cord Injury This study will test the newly-developed My spinal cord injury (SCI) Toolkit program in two formats - unguided use of the program and use supported by a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10406314/

Development of a pain education resource for people with ... Global ratings of difficulty in dealing with chronic pain and other consequences of injury have previously been used in the SCI population (40).

6. scireproject.com scireproject.com/wp-content/uploads/2022/04/OM-Toolkit-v.3.0.pdf

A set of 33 Outcome Measures recommended by experts in ... With 33 psychometrically validated measures, the toolkit provides a standardized set of outcome measures for use in your SCI clinical practice.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130588/

The Spinal Cord Injury Self-Management Program: A Pilot People with chronic spinal cord injury (SCI) experience a higher rate of secondary health conditions (SHCs) which affect their health and well-being.