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Behavioral Intervention
Chronic Pain Self-Management Program for Chronic Pain
N/A
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported chronic musculoskeletal pain (pain in muscles or joints for >= 3 months); >=4 (0-10 scale) average pain level over last week; >=1 day/previous 30 when pain made it difficult to do usual activities.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months from baseline, and 12 months from baseline
Awards & highlights
Study Summary
This trialwill test if CHWs can effectively teach strategies to reduce pain in older adults in an urban setting, and measure the effects of this intervention.
Who is the study for?
This trial is for older adults living in the community who have chronic musculoskeletal pain. Participants must have had pain for at least 3 months, with an average pain level of 4 or higher on a scale of 0-10 over the last week and experienced difficulty in daily activities due to pain. They should be able to speak English and have access to a phone.Check my eligibility
What is being tested?
The STEPS program aims to teach older adults cognitive-behavioral strategies for managing chronic pain through telephone sessions with community health workers and mobile health tools. The study will compare this approach against usual care over a period of 7 weeks, evaluating its effectiveness after 2 and 12 months.See study design
What are the potential side effects?
Since STEPS is a self-management educational intervention involving non-pharmacological techniques taught by community health workers, it does not involve medication or medical procedures that typically cause side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had muscle or joint pain for over 3 months, with an average pain level of 4 or more in the last week, and there was at least one day in the last month when pain interfered with my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months from baseline, and 12 months from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months from baseline, and 12 months from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain Interference
Secondary outcome measures
Change in pain intensity
Participant Global Impression of Change - Functioning
Pain
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Participants will engage in a 7-week multicomponent chronic pain self-management program.
Group II: Usual care control armActive Control1 Intervention
After completing the 12 month telephone survey, control group participants will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a workshop that provides key intervention content and individualized goal-setting guidance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STEPS
2014
N/A
~270
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,108 Total Patients Enrolled
31 Trials studying Chronic Pain
3,392 Patients Enrolled for Chronic Pain
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,035 Total Patients Enrolled
16 Trials studying Chronic Pain
1,891 Patients Enrolled for Chronic Pain
Henry Ford Health SystemOTHER
299 Previous Clinical Trials
2,098,333 Total Patients Enrolled
2 Trials studying Chronic Pain
61 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had muscle or joint pain for over 3 months, with an average pain level of 4 or more in the last week, and there was at least one day in the last month when pain interfered with my daily activities.You live in the community, not in a care facility.I do not have severe mental, physical, or psychiatric conditions that would prevent me from participating.I have not been seriously ill or hospitalized in the last month.I do not have any major surgeries planned that would stop me from joining the program.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
- Group 2: Usual care control arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for qualified participants in this research experiment?
"In accordance with the data available on clinicaltrials.gov, this trial is currently searching for patients to enrol in its program. The first posting was made on November 29th 2022 and it was last updated on December 1st 2022."
Answered by AI
What is the aggregate number of participants enrolled in this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this experiment, which was first posted on November 29th 2022, is actively seeking volunteers. Approximately 414 individuals must be recruited from 1 facility for the study to commence."
Answered by AI
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