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Behavioural Intervention
eHealth Program for Chronic Pain in Spinal Cord Injury
N/A
Recruiting
Led By Anna Kratz, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fluent in English and able to read English at a 6th grade level
Average pain intensity over the past 3 months greater or equal to (≥) 4/10 on 0-10 numerical rating scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial tests a new program to help adults with chronic pain & spinal cord injury. Treatments are compared for adherence, satisfaction & pain interference.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-medical interventions (eHealth programs), traditional side effects like those from medication are not expected. However, participants may experience discomfort or frustration using the technology or emotional distress engaging with their chronic pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can read and understand English at a 6th grade level.
Select...
My average pain level has been 4 or more out of 10 for the past 3 months.
Select...
I have been diagnosed with a spinal cord injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in SCI-QOL Pain Interference Short Form
Number of days/week that My SCI Toolkit was accessed
Number of minutes/week spent on the My SCI Toolkit website
+3 moreSecondary outcome measures
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form
Change in SCI-QOL Pain Behavior Short Form
Trial Design
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 Location
Who is running the clinical trial?
The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,875 Total Patients Enrolled
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,078 Total Patients Enrolled
Anna Kratz, PhDPrincipal InvestigatorUniversity of Michigan
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment currently taking place for this experiment?
"Clinicaltrials.gov suggests that this particular trial, which was published on October 1st 2023 and last modified 18 days later, is not currently recruiting patients for participation - however, there are 804 other medical studies actively searching for volunteers at the moment."
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