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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

Must not have

Serious acute illness or hospitalization in last month

Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months from baseline, and 12 months from baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been seriously ill or hospitalized in the last month.

Select...

I do not have any major surgeries planned that would stop me from joining the program.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Interference

Secondary study objectives

Change in pain intensity

Participant Global Impression of Change - Functioning

Pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met