Chronic Pain Self-Management Program for Chronic Pain

Overseen By Mary Janevic, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether community health workers can teach effective pain management techniques to older adults in an urban setting. The study focuses on the STEPS Pain Self-Management Program, delivered over the phone and using mobile health tools. Researchers will compare participants to a group receiving usual care to determine if the program improves pain outcomes over time. Ideal candidates for this trial are those who have experienced chronic muscle or joint pain for at least three months and struggle with daily activities due to pain. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management strategies that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on teaching pain management strategies rather than changing medications.

What prior data suggests that the STEPS Pain Self-Management Program is safe?

Research shows that participants generally find the STEPS pain self-management program easy to handle. In a previous study, all participants agreed or strongly agreed that the program improved their understanding of pain management. On average, participants completed nearly all sessions, indicating they found it manageable and engaging.

Another study found that participants experienced significant benefits, including better health and reduced depression, anxiety, and pain. This suggests the program is not only safe but also effective in enhancing overall well-being.

Since STEPS does not involve medication, it employs strategies that focus on changing thoughts and behaviors, reducing the likelihood of side effects often associated with drugs. The evidence so far supports its safety and effectiveness for those dealing with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEPS program for chronic pain because it offers a comprehensive, self-managed approach unlike traditional options such as medication or physical therapy. It combines multiple components, including education, physical activity, and personalized goal-setting, empowering patients to take control of their pain management. This multifaceted strategy not only addresses the physical aspects of pain but also promotes long-term behavioral changes, which could lead to improved outcomes and quality of life for participants.

What evidence suggests that the STEPS Pain Self-Management Program is effective for chronic pain?

Research has shown that the STEPS pain self-management program, which participants in the intervention arm of this trial will engage in, helps people understand and manage their chronic pain better. One study, primarily involving older African American adults, found that participants managed their pain more effectively after completing the program. On average, they attended nearly all the sessions and reported learning useful pain management techniques. Additional findings indicated that the program increased participants' confidence in managing their pain and aided in their acceptance of it. These results suggest that the STEPS program could effectively manage chronic pain. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Have a cell or landline phone

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 7-week multicomponent chronic pain self-management program delivered through telephone sessions with a CHW and mobile health tools

7 weeks

Weekly telephone sessions

Follow-up

Participants are monitored for pain outcomes and functioning at 2 and 12 months after baseline

12 months

Telephone surveys at 2 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• STEPS

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Participants will engage in a 7-week multicomponent chronic pain self-management program.

Group II: Usual care control arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

A 14-day Comprehensive Out-patient Pain Engagement programme for chronic pain patients in Hong Kong led to significant improvements in physical function and psychological well-being, as measured by various assessment tools, including the Medical Outcome Survey and Pain Catastrophizing Scale.

The programme also resulted in increased physical tolerances for standing and sitting, and a notable improvement in employment rates, suggesting enhanced productivity among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with a chronic pain management programme in Hong Kong Chinese patients. Man, AK., Chu, MC., Chen, PP., et al.[2018]

A randomized controlled trial involving 215 veterans with chronic musculoskeletal pain tested a peer coach-delivered pain self-management program, but adherence to the program was low, with only 13% of patients attending the recommended number of meetings.

Both the peer support and control groups showed a decrease in total pain over 9 months, but there was no significant difference in pain reduction or other secondary outcomes between the two groups, suggesting that the peer support model may need to be revised for better effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial. Matthias, MS., Bair, MJ., Ofner, S., et al.[2021]

The Stanford Chronic Pain Self-Management Programme (CPSMP) did not significantly reduce pain-related disability or healthcare costs in a study of 424 adults with chronic pain, indicating it may not be an effective treatment for this issue.

While there were small improvements in emotional distress and illness worry three months after the program, these changes were clinically insignificant, suggesting that the CPSMP may not provide meaningful benefits for individuals suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme. Mehlsen, M., Hegaard, L., Ørnbøl, E., et al.[2023]

A chronic pain treatment program lasting 7-8 weeks, followed by 4 weeks of outpatient care, successfully modified pain behaviors in patients, leading to a significant increase in activity levels and a reduction in pain medication use.

Of the 34 patients who completed the program, 74% maintained their improved activity levels and quality of life during follow-up periods ranging from 6 months to 7 years, demonstrating the long-term efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior modification of chronic pain: a treatment program by a multidisciplinary team. Anderson, TP., Cole, TM., Gullickson, G., et al.[2011]

A new self-management program for chronic pain, which included pain education and individualized exercises, showed potential to improve function in some participants, with changes ranging from a 59% improvement to a 17% decline among six individuals over 18 weeks.

Participants reported high satisfaction with the program, but variability in outcomes suggests that factors like attendance and social context may influence effectiveness, indicating a need for strategies to enhance adherence and address barriers to participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depicting individual responses to physical therapist led chronic pain self-management support with pain science education and exercise in primary health care: multiple case studies. Miller, J., MacDermid, JC., Richardson, J., et al.[2022]

This study will evaluate a 6-week self-management program that combines pain science education and exercise for 110 participants with chronic pain, aiming to improve functional outcomes compared to a wait-list control group.

The primary focus is on enhancing function as measured by the Short Musculoskeletal Function Assessment, with secondary outcomes including pain intensity and self-efficacy, which will help identify predictors of treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain self-management support with pain science education and exercise (COMMENCE): study protocol for a randomized controlled trial. Miller, J., MacDermid, JC., Walton, DM., et al.[2018]

A 4-week Pain Coping Strategies (PCS) program significantly improved mood, functional status, and physical ability in 31 chronic pain patients, as measured by standardized scales before and 6 weeks after the program.

The study suggests that early intervention with pain management strategies can effectively promote self-management and positive coping skills in chronic pain patients, even while they are undergoing other medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Mead, K., Theadom, A., Byron, K., et al.[2011]

A 9-week group program for chronic pain management involving 75 patients led to significant reductions in depression, pain perception, and the need for pain medication, indicating its efficacy in improving coping strategies.

The program also resulted in an increase in employment rates from 20% to 48%, suggesting that effective pain management can enhance patients' ability to return to work, although 21% of participants did not achieve the desired outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain control: mastery through group experience. Herman, E., Baptiste, S.[2021]

Self-management interventions are effective in improving pain, mental health, and quality of life for individuals living with chronic pain, regardless of the format (individual, group, or online).

Acceptance of chronic pain is crucial for individuals to engage in self-management, and clinicians can significantly support this process by providing guidance and encouragement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management interventions for chronic pain. Mann, EG., Lefort, S., Vandenkerkhof, EG.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05278234

STEPS: An Efficacy Trial of a Chronic Pain Self ... Specific aims are: to test, in a sample of 414 primarily African American older adults, whether the STEPS pain self-management intervention, delivered over 7 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9714529/

A Pilot Study of a Chronic Pain Self-Management Program ... Participants on average completed 6.6/7 sessions, and 100% agreed or strongly agreed that they improved their understanding of pain management.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1524904224002856

Actively Waiting: Feasibility and Acceptability of a Virtual ... Exploratory analyses were performed and supported improvement in self-efficacy and chronic pain acceptance outcomes in both groups. Coaching did not augment ...

4. researchgate.net researchgate.net/publication/392334114_A_community_health_worker-delivered_intervention_STEPS_to_support_chronic_pain_self-management_among_older_adults_in_an_underserved_urban_community_protocol_for_a_randomized_trial

A community health worker-delivered intervention (STEPS ... We hypothesize that participants in the STEPS intervention will have greater improvements in pain interference and pain intensity, and a more positive Global ...

5. jospt.org jospt.org/doi/10.2519/josptopen.2024.0070

Optimization of a Self-management Program for Chronic ... The primary outcome measure is pain-related disability after 10 weeks. Secondary objectives include comparing the effects of both delivery modes ...

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08892-w

A community health worker-delivered intervention (STEPS) to ... The purpose of this study is to test the efficacy of a chronic pain self-management intervention tailored for this context. STEPS (Seniors using ...

7. withpower.com withpower.com/trial/phase-chronic-pain-1-2024-9a1c9

STEP-UP Program for Chronic Pain · Info for Participants Participants experienced significant improvements in patient activation, health status, and reductions in depression, anxiety, and pain severity, indicating the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12274742/

Effectiveness of an app-delivered, self-management ... A m-health-based core stability exercise self-management program combined with health education was more effective in reducing pain intensity, ...