Self-Management Programs for Chronic Back and Neck Pain

(P4P Trial)

Overseen By Roni L Evans, DC, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Severe mental illness, Cancer, Dementia, Pregnancy

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

Compensation: Varies

Number of Visits: 14

Duration: 9 weeks

376 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain from populations that have been minoritized based on race, ethnicity, or income. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

Is self-management for chronic back and neck pain safe for humans?

The research does not provide specific safety data for self-management programs for chronic back and neck pain, but these programs generally involve non-invasive techniques like education and lifestyle changes, which are typically safe for humans. ^{1 2 3 4 5}

What makes the treatment 'Keys to Wellbeing, Partners4Pain' unique for managing chronic back and neck pain?

This treatment is unique because it emphasizes a partnership between patients and health professionals to support self-management of chronic pain, focusing on effective communication and individualized care, which is not commonly highlighted in other treatments. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Keys to Wellbeing, Partners4Pain, Partners4Pain & Wellbeing Equity, Community Supported Complementary and Integrative Health Self-management for Back Pain?

Research suggests that self-management programs for chronic back pain are more effective when patients and health professionals work together, emphasizing communication and mutual understanding. Integrative medicine models, which combine conventional and alternative approaches, have shown promise in managing back and neck pain, indicating potential benefits for these treatments. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals from underrepresented communities based on race, ethnicity, or income who suffer from chronic back or neck pain. Participants will be screened to ensure they meet the study's requirements and must commit to attending weekly sessions and completing several surveys.

Inclusion Criteria

I have had chronic back or neck pain for over 3 months.

Member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native; Asian; Black/African American; Hispanic/Latino; Native Hawaiian/Pacific Islanders; Socioeconomically disadvantaged (annual household income less than $50,000)

Score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity scale (PEG scale - 0-10)

Exclusion Criteria

Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment

Severe unmanaged mental illness

I am currently undergoing radiation or chemotherapy for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (in-person)

Treatment

Participants attend 9 weekly self-management program sessions focusing on mind-body skills or general health and wellbeing

9 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys completed at 2, 4, and 6 months

4 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Keys to Wellbeing
• Partners4Pain

Trial Overview The trial compares two self-management programs: Partners4Pain, which teaches mind-body skills like mindfulness and cognitive behavioral strategies; versus Keys to Wellbeing, focusing on general health. The effectiveness in reducing pain intensity and its impact on life activities will be measured.

How Is the Trial Designed?

Group I: Partners4Pain Experimental Treatment 1 Intervention

Community-based program that focuses on evidence based mind-body tools (mindfulness, cognitive behavioral approaches) for pain self-management in addition to pain education and physical exercises.

Group II: Keys to Wellbeing Active Control 1 Intervention

Community-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A study involving 147 patients with chronic back pain found a strong association between patient-professional partnerships and improved self-management abilities, indicating that collaborative care can enhance patient outcomes.

Qualitative interviews with a subset of 26 patients revealed that effective partnerships with health professionals lead to increased knowledge, better symptom management, and a greater sense of safety, suggesting that partnership-building should be a focus in healthcare training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between patient-professional partnerships and self-management of chronic back pain: A mixed methods study. Fu, Y., Yu, G., McNichol, E., et al.[2019]

In a study of 218 adults visiting primary care for back pain, conversations about alternative medicine occurred in only 14% to 40% of consultations, depending on the location (Seattle, Israel, and Birmingham).

Patients who used alternative medicine were significantly more likely to initiate discussions about it with their doctors, highlighting a gap in communication where many patients did not discuss their alternative treatments during consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doctor-patient discussions of alternative medicine for back pain. Neher, JO., Borkan, JM., Wilkinson, MJ., et al.[2019]

The pilot study successfully enrolled 80 patients with non-specific back/neck pain, demonstrating that integrating an integrative medicine (IM) model into Swedish primary care is feasible, with a high follow-up completion rate of 82% for IM care and 75% for conventional care.

While the study was underpowered to find significant differences, there was a clinically relevant improvement in vitality for the IM group and a trend towards reduced use of analgesics, suggesting potential benefits of IM over conventional care that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial. Sundberg, T., Petzold, M., Wändell, P., et al.[2021]

Effective partnerships between patients and healthcare professionals significantly enhance patients' ability to self-manage chronic back pain, as identified through a systematic review of 10 qualitative studies.

Key factors such as effective communication, mutual understanding, and individualized care are crucial in these partnerships, suggesting that tailored healthcare services could improve self-management outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-professional partnerships and chronic back pain self-management: a qualitative systematic review and synthesis. Fu, Y., McNichol, E., Marczewski, K., et al.[2022]

In a study of 184 patients with chronic neck or low back pain, receiving information about the effectiveness of self-management strategies significantly increased adherence to nonpharmacologic pain management strategies (adjusted odds ratio of 10.1).

While information about the illness also improved adherence (adjusted odds ratio of 3.4), it did not affect adherence to neck/back care in daily activities, suggesting that the type of information provided is crucial for encouraging self-management in chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of chronic neck and low back pain and relevance of information provided during clinical encounters: an observational study. Escolar-Reina, P., Medina-Mirapeix, F., Gascón-Cánovas, JJ., et al.[2009]

The study involving 147 patients with chronic back pain found that improving self-management abilities significantly enhances health-related quality of life (HRQoL) after three months of pain management support.

While a strong patient-professional partnership did not directly improve HRQoL, it positively influenced self-management skills, which in turn led to better health outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of patient-professional partnerships on the self-management and health outcomes for patients with chronic back pain: A quasi-experimental study. Fu, Y., Yu, G., McNichol, E., et al.[2022]

Consumers with chronic low back pain (CLBP) in rural Western Australia face significant barriers to accessing information and services, including poor availability of interdisciplinary care and inadequate local practitioner knowledge.

Competing lifestyle demands, such as work and family commitments, hinder effective self-management of CLBP, highlighting the need for improved health service coordination and a skilled workforce in pain management for better service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumers' experiences of back pain in rural Western Australia: access to information and services, and self-management behaviours. Briggs, AM., Slater, H., Bunzli, S., et al.[2022]

Citations

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

The association between patient-professional partnerships and self-management of chronic back pain: A mixed methods study. [2019]

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

Doctor-patient discussions of alternative medicine for back pain. [2019]

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

Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Patient-professional partnerships and chronic back pain self-management: a qualitative systematic review and synthesis. [2022]

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

Self-management of chronic neck and low back pain and relevance of information provided during clinical encounters: an observational study. [2009]

6. England pubmed.ncbi.nlm.nih.gov

The effects of patient-professional partnerships on the self-management and health outcomes for patients with chronic back pain: A quasi-experimental study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Consumers' experiences of back pain in rural Western Australia: access to information and services, and self-management behaviours. [2022]