73 Participants Needed

eHealth Program for Chronic Pain in Spinal Cord Injury

KP
AK
Overseen ByAnna Kratz, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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 coach. These two active treatment formats will be compared to treatment as usual (waitlist control) in adults with chronic pain and SCI. Hypotheses include: * Treatment adherence, participant satisfaction, and perception of positive change will be high and drop-out rates low for both treatments but will be better in the coached compared to the unguided arm * In terms of pre- to post-treatment changes in pain interference, coached My SCI Toolkit program will be superior to treatment as usual

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 data supports the effectiveness of the My SCI Toolkit treatment for chronic pain in spinal cord injury?

Research suggests that multimodal treatment strategies, which include education and cognitive-behavioral approaches, can be effective for managing chronic pain in people with spinal cord injury. The development of educational resources and self-management tools, like mobile apps, has shown promise in helping individuals manage their pain and improve their quality of life.12345

How is the My SCI Toolkit treatment different from other treatments for chronic pain in spinal cord injury?

The My SCI Toolkit program is unique because it is an eHealth program specifically designed for people with spinal cord injury, focusing on increasing health literacy and improving communication with healthcare providers, which is not typically emphasized in standard treatments.12678

Research Team

AK

Anna Kratz, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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
I can read and understand English at a 6th grade level.
Access to internet connected device (phone, tablet, computer) and telephone
See 2 more

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

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

Treatment Details

Interventions

  • My SCI Toolkit program
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Unguided use of the My SCI Toolkit programExperimental Treatment1 Intervention
Group II: Coached My SCI ToolkitExperimental Treatment1 Intervention
Group III: Wait-list controlActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Evaluation of an interdisciplinary program for chronic pain after spinal cord injury. [2018]
Development of a pain education resource for people with spinal cord injury. [2023]
Comparison of a pain management program with usual care in a pain management center for people with spinal cord injury-related chronic pain. [2018]
Development of a Self-Management App for People with Spinal Cord Injury. [2020]
Pain and pain management experiences following spinal cord injury - a mixed methods study of Australian community-dwelling adults. [2023]
Chronic pain experience and pain management in persons with spinal cord injury in Nepal. [2019]
Outcomes and reflections on a consensus-building workshop for developing a spinal cord injury-related chronic pain research agenda. [2023]
Subgroup Perspectives on Chronic Pain and Its Management After Spinal Cord Injury. [2020]