STEP-UP Program for Chronic Pain

(STEP-UP Trial)

Overseen By Rebecca Lindsay, MPH

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: Unknown

Duration: 7 weeks

40 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that STEP-UP Program for Chronic Pain is an effective treatment?

The available research shows that online pain management programs, similar to the STEP-UP Program, have been effective in improving pain intensity, quality of life, and reducing depression in people with chronic musculoskeletal pain. Although the improvements were small, they were significant. Additionally, a study in the UK found that a self-management program for chronic pain led to better health status, lower depression and anxiety, and improved self-management skills. These findings suggest that programs like STEP-UP can be effective in managing chronic pain. ^{1 2 3 4 5}

What safety data exists for the STEP-UP Program for Chronic Pain?

The provided research does not directly address the safety data for the STEP-UP Program for Chronic Pain. However, it includes information on online pain management programs and self-management interventions, which may be relevant. The systematic review of online pain management programs found improvements in pain intensity, quality of life, and depression, but noted a high risk of bias and small effect sizes. The research suggests that guided interventions are more effective than self-completed ones. No specific safety concerns are mentioned, but future research should standardize outcome measures and consider long-term effects. ^{1 2 6 7 8}

Is the STEP-UP treatment a promising way to help with chronic pain?

Yes, the STEP-UP treatment is promising because it focuses on educating people about chronic pain and teaching them how to manage it themselves. This approach has been shown to reduce pain, improve health status, and help people feel more in control of their pain. ^{1 3 9 10 11}

What is the purpose of this trial?

This randomized Stage 1 pilot trial tests the feasibility of a community health worker (CHW) delivered chronic pain self-management intervention for older adults ("STEP-UP"; Support, Training, and Education for Pain Self-Management - Using Podcasts) in a primary care setting. A total of 40 participants aged 50+ with high-impact chronic pain will be randomized to intervention or control groups. The STEP-UP intervention will feature an educational podcast series teaching core pain self-management skills. Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period. The Community Health Worker will guide participants in a modified Patient Priorities of Care approach to help them identify their values and priorities and develop goals that reflect these.

Eligibility Criteria

This trial is for adults over 50 with high-impact chronic musculoskeletal pain that often disrupts daily life or work. Participants must have a phone, not have done similar pain management programs in the last 5 years, and be comfortable speaking English.

Inclusion Criteria

I am over 50 years old.

Able to converse comfortably in English

Have not participated in another chronic pain self-management intervention in the last 5 years

Exclusion Criteria

Severe cognitive impairment or other severe physical or psychiatric disorder judged by the study team to pose a significant barrier to participation

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

I do not have any major surgeries planned that would interfere with the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the STEP-UP intervention, which includes educational podcasts and sessions with a Community Health Worker over a 7-week period

7 weeks

Sessions at designated times

Follow-up

Participants are monitored for changes in pain interference and other outcomes

8 weeks

Control Group Intervention

Control group participants are invited to take part in the STEP-UP intervention after completing the follow-up survey

Treatment Details

Interventions

• STEP-UP

Trial Overview The 'STEP-UP' program is being tested to see if it helps older adults manage chronic pain through educational podcasts and support from Community Health Workers. The study will compare a group receiving this intervention with a control group over seven weeks.

Participant Groups

Group I: STEP-UP intervention group Experimental Treatment 1 Intervention

Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.

Group II: Control group Active Control 1 Intervention

Members of the control group will not initially receive the STEP-UP intervention. After completing the 8-week follow-up telephone survey, individuals in the control group will be invited to take part in the STEP-UP intervention.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Western Wayne Family Health Centers

Collaborator

Trials

1

Recruited

40+

Findings from Research

Pain neuroscience education (PNE) is effective in reducing pain and improving function in individuals with chronic musculoskeletal pain, based on a systematic review of 13 randomized control trials.

PNE not only enhances patient understanding of pain but also lowers disability, reduces psychosocial factors, improves movement, and decreases healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Louw, A., Zimney, K., Puentedura, EJ., et al.[2022]

Online pain management programs for chronic musculoskeletal conditions showed significant improvements in pain intensity, health-related quality of life, and depression scores, based on a systematic review of 18 randomized controlled trials involving 3546 studies.

Despite these improvements, the effect sizes were small and did not reach the minimal clinically important change, suggesting that while online programs can be beneficial, they may not be sufficient alone for significant clinical impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online pain management programs for chronic, widespread musculoskeletal conditions: A systematic review with meta-analysis. Chew, MT., Chan, C., Kobayashi, S., et al.[2023]

A 7-week self-management program for chronic musculoskeletal pain was attended by 376 out of 528 recruited patients, showing a high uptake rate of 71% and an 82% completion rate among those who participated.

Participants experienced significant improvements in patient activation, health status, and reductions in depression, anxiety, and pain severity, indicating the program's efficacy in enhancing self-management skills for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of uptake and effect on patient-reported outcomes of a clinician and patient co-led chronic musculoskeletal pain self-management programme provided by the UK National Health Service. Anderson, JK., Wallace, LM.[2020]

Chronic pain affects many people and comes with high costs, but access to effective behavioral interventions is limited due to barriers like a shortage of trained clinicians and inadequate insurance coverage.

Recent technological advancements present new opportunities to improve access to evidence-based pain education and treatments for both children and adults, potentially overcoming existing challenges in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. Darnall, BD., Edwards, KA., Courtney, RE., et al.[2023]

This trial will evaluate the effectiveness and implementation of three different online pain education strategies for chronic musculoskeletal pain in Brazil, involving adult participants from primary healthcare, with assessments at baseline, 10 weeks, and 6 months.

The study aims to enhance self-management of chronic pain through a collaborative model involving healthcare professionals and patients, while also providing valuable insights for future public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an online pain science education for chronic musculoskeletal pain in Brazilian public health system: protocol for a hybrid type III randomised controlled trial with economic evaluation. Baroni, MP., Hespanhol, L., Miyamoto, GC., et al.[2023]

The Hunter Integrated Pain Service created three educational videos on chronic pain treatment, emphasizing a whole-person approach and self-management, which have collectively received over 700,000 views since their release, indicating widespread interest and potential impact.

These videos serve as a low-cost public health intervention to reduce clinical variation in chronic pain treatment, and they have been translated into multiple languages, enhancing accessibility and education for diverse audiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using social media to challenge unwarranted clinical variation in the treatment of chronic noncancer pain: the "Brainman" story. White, R., Hayes, C., White, S., et al.[2022]

An online self-management program for chronic pain was developed with the active involvement of people with lived experience (PWLE), ensuring the content is relevant and sensitive to their needs.

Usability testing showed that the program, which includes eight interactive modules and motivational interviewing coaching, was highly accessible and easy to use, setting the stage for future studies on its effectiveness in helping individuals manage chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience-based design: Empowering individuals while they wait for interprofessional chronic pain care. Bosma, R., Bisson, EJ., Cooper, LK., et al.[2023]

A study involving 121 participants with chronic pain found that a 3-month group-based self-management course did not significantly improve patient activation compared to a low-impact outdoor physical activity group.

Both interventions were equally effective, suggesting that simple physical activity may be as beneficial as structured self-management courses for individuals with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. Nøst, TH., Steinsbekk, A., Bratås, O., et al.[2020]

A systematic review of nine studies on educational interventions for chronic pain found that education alone does not significantly reduce pain or disability in adults, with pooled data showing no improvement compared to usual care.

The only positive outcome was observed with pain neurophysiology education (PNE), which showed a decrease in disability and improved knowledge about pain, but the evidence is not strong enough to recommend PNE as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. Geneen, LJ., Martin, DJ., Adams, N., et al.[2022]

The Chronic Pain Self-Management Programme (CPSMP) was found to be feasible and well-received by participants, with over 75% recommending it to others, indicating its potential for broader implementation.

Participants in the CPSMP experienced significant and stable improvements in pain, disability, and psychological factors like anxiety and depression over a 5-month follow-up, although the overall changes were modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. Mehlsen, M., Heegaard, L., Frostholm, L.[2022]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Online pain management programs for chronic, widespread musculoskeletal conditions: A systematic review with meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of uptake and effect on patient-reported outcomes of a clinician and patient co-led chronic musculoskeletal pain self-management programme provided by the UK National Health Service. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Implementation of an online pain science education for chronic musculoskeletal pain in Brazilian public health system: protocol for a hybrid type III randomised controlled trial with economic evaluation. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Using social media to challenge unwarranted clinical variation in the treatment of chronic noncancer pain: the "Brainman" story. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Experience-based design: Empowering individuals while they wait for interprofessional chronic pain care. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Pain control: mastery through group experience. [2021]