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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~2 months from baseline, and 12 months from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months from baseline, and 12 months from baseline for reporting.

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

STEPS (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05278234 — N/A
Chronic Pain Research Study Groups: Intervention arm, Usual care control arm
Chronic Pain Clinical Trial 2023: STEPS Highlights & Side Effects. Trial Name: NCT05278234 — N/A
STEPS (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05278234 — N/A

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
~248 spots leftby Apr 2026