Tailored PainGuide for Chronic Lower Back Pain

Overseen By Sana Shaikh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cancer pain, Autoimmune disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an online tool, PainGuide, can help manage chronic lower back pain by changing behaviors. It compares two versions of the tool: a standard version and a personalized, structured version. Researchers believe a tailored digital approach might more effectively reduce pain's interference with daily life. Individuals with low back pain for at least six months who face significant daily challenges may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pain management strategies.

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.

Will I have to stop taking my current medications?

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

What prior data suggests that this digital intervention is safe for managing chronic lower back pain?

Research has shown that the Tailored PainGuide, a digital tool for managing pain, is under study for its effects on chronic low back pain. Specific safety information for this tool is not yet available. However, because it does not involve medication, the risks are generally lower than those of drug treatments.

The PainGuide platform serves as an educational tool to help individuals manage chronic pain independently. Since it is not a medication, the likelihood of side effects is very low, making it a low-risk option for those interested in exploring new pain management methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tailored PainGuide for chronic lower back pain because it offers a personalized approach to pain management. Unlike standard treatments, which often rely on a one-size-fits-all model, the Tailored PainGuide is structured to adapt to individual patient needs, potentially leading to more effective pain relief. This personalized method aims to enhance patient engagement and outcomes by considering personal factors that influence pain perception and management. By focusing on customization, this approach could revolutionize how chronic lower back pain is treated, offering hope for those who haven't found relief with standard therapies.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

Research has shown that personalized digital tools can help manage chronic lower back pain by encouraging behavior changes. In this trial, participants will receive either the Standard PainGuide or the Structured and tailored PainGuide. Early results suggest that a structured and customized PainGuide might improve how pain affects daily activities. This method operates on the idea that tailoring treatment to individual needs can lead to better results. By focusing on changing behaviors, the tailored PainGuide aims to reduce how much pain disrupts life more effectively than standard treatments. This approach could be promising for those who find typical treatments less effective. ^{1 2 4 5 6}

Who Is on the Research Team?

Daniel Clauw, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people who have had lower back pain for at least six months, on more than half of those days, and experience significant disruption due to this pain. Participants must understand English and not be pregnant or breastfeeding. They can't join if they have cancer-related pain, autoimmune diseases, severe visual/hearing issues, or other conditions that the study leaders think would make them unsuitable.

Inclusion Criteria

You need to have a pain interference score of 60 or higher on the PROMIS test.

I have had lower back pain for at least six months, on most days.

Exclusion Criteria

I have problems with my sight or hearing.

I have been diagnosed with an autoimmune disease.

Unable to speak, write or read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the PainGuide digital intervention tailored to their needs

24 weeks

Online engagement with the PainGuide platform

Follow-up

Participants are monitored for changes in pain interference and other outcomes

28 weeks

Online assessments at Week 24 and Week 52

What Are the Treatments Tested in This Trial?

Interventions

• Standard PainGuide
• Structured and tailored PainGuide

Trial Overview The study is testing two versions of an electronic self-management website called PainGuide: a standard version and one tailored to individual behaviors. It aims to see if the tailored guide helps reduce how much chronic low back pain interferes with daily activities more effectively.

How Is the Trial Designed?

Group I: Structured and tailored PainGuide Experimental Treatment 1 Intervention

Group II: Standard PainGuide Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A study involving 219 veterans over 12 weeks showed high satisfaction with the 'Pain Education School' program, with participants reporting that the information was new, useful, and easy to understand.

Participants felt empowered to use the information learned in the program and were likely to recommend it to others, indicating its effectiveness in educating patients about managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed-method approach to veteran satisfaction with pain education. Watson, EC., Cosio, D., Lin, EH.[2014]

This study will evaluate the effectiveness of the Pain Toolkit, a self-management tool for persistent pain, against a simple education control in individuals with low back pain, involving participants who have been discharged from a regional back pain pathway.

The primary outcome will be measured using the Oswestry Disability Index (ODI) at 6 and 12 months, with a clinically important change defined as a 10-point difference, while qualitative interviews will explore user experiences with the Pain Toolkit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for an investigation of the effectiveness of the pain toolkit for people with low back pain: double-blind randomised controlled trial. Findley, G., Ryan, C., Cartwright, A., et al.[2023]

The infographic summarizes updated clinical practice guidelines for managing acute and chronic low back pain, emphasizing evidence-based interventions.

These guidelines are based on a comprehensive review of current research, aiming to improve treatment outcomes for patients suffering from low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Acute and Chronic Low Back Pain. [2022]

The British Pain Society and Map of Medicine have developed guidelines to improve the treatment of low back pain, focusing on ensuring continuity of care across various medical specialties.

The guidelines outline a care pathway designed to streamline patient management, which is crucial given the complexity of low back pain treatment involving multiple healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of low back pain. Lee, J.[2016]

The PainData registry analyzed data from over 12,000 patients with chronic pain in Denmark, revealing that many suffer from long-term pain (average duration of 10 years) and significant comorbidities, including poor sleep and fatigue.

After treatment, about 25% of patients reported significant improvements, highlighting the registry's potential to enhance understanding and management of chronic pain through patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socio-Demographics, Pain Characteristics, Quality of Life and Treatment Values Before and After Specialized Interdisciplinary Pain Treatment: Results from the Danish Clinical Pain Registry (PainData). Vaegter, HB., Christoffersen, LO., Enggaard, TP., et al.[2022]

The SOULAGE-TAVIE intervention, a tailored Web-based program for postoperative pain management, was developed and validated through a structured process involving 30 cardiac surgery patients over 4 months, showing high acceptability with 96% of participants finding the strategies helpful.

This innovative approach emphasizes patient empowerment and personalized education, suggesting that using technology can enhance the effectiveness of pain management strategies in a complex healthcare environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOULAGE-TAVIE: development and validation of a virtual nursing intervention to promote self-management of postoperative pain after cardiac surgery. Martorella, G., Côté, J., Choinière, M.[2022]

Education about the benign and multifactorial nature of chronic non-specific low back pain is crucial, as it can help patients adopt better coping strategies and improve their pain management.

The development of an educational tool for patients in Primary Care physiotherapy is essential to address psychosocial factors and enhance the effectiveness of physical exercise in managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Design of an educational tool for Primary Care patients with chronic non-specific low back pain]. Díaz-Cerrillo, JL., Rondón-Ramos, A.[2021]

A review of 13 clinical practice guidelines for managing chronic nonspecific low back pain showed that the quality of these guidelines has improved, with strong consensus on the importance of diagnostic triage and assessing prognostic factors.

Key therapeutic recommendations across the guidelines include the use of information, exercise therapy, multidisciplinary treatment, and combined physical and psychological interventions, highlighting a shift towards more comprehensive care for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated overview of clinical guidelines for chronic low back pain management in primary care. Pillastrini, P., Gardenghi, I., Bonetti, F., et al.[2022]

The Learning About My Pain study is a significant trial involving 294 participants that aims to compare the effectiveness of cognitive-behavioral and educational pain interventions against usual care for chronic pain management.

This study is one of the first funded by the Patient-Centered Outcomes Research Institute, emphasizing low-risk psychosocial treatments that may provide benefits without the undesirable side effects associated with medical pain treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Learning About My Pain study protocol: Reducing disparities with literacy-adapted psychosocial treatments for chronic pain, a comparative behavioral trial. Eyer, JC., Thorn, BE.[2018]

A pilot study involving 20 patients with chronic low back pain showed that using a specially designed website for five months led to decreased pain intensity and increased physical activity compared to a control group of 15 patients.

Participants using the website also reported reduced medical consultations and painkiller use, along with improved knowledge about managing their condition, indicating the website's potential effectiveness in self-management of chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An internet-based approach to enhance self-managementof chronic low back pain in the italian-speaking population of Switzerland: results from a pilot study. Schulz, PJ., Rubinell, S., Hartung, U.[2022]

Patients with high-impact chronic pain found the Smerteinfo.dk website valuable for accessing information and reported improvements in understanding their condition (56%) and coping strategies (33%) after using it.

Despite its benefits, users expressed a need for more personalized information and better navigation tools, highlighting the importance of continuous updates and enhancements to the website based on user feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience and usability of a website containing research-based knowledge and tools for pain self-management: a mixed-method study in people with high-impact chronic pain. Laerkner, E., Bendix, L., Jäger, M., et al.[2023]

The St. Gallen Pain Evolution Chart (S-PEC) is a proposed tool for documenting pain in tumor patients, which includes tracking pain location and intensity throughout the day and night, emphasizing the importance of thorough pain management.

Regular use of the pain evolution chart in hospital records encourages patients and caregivers to engage actively in pain management, benefiting both clinical practice and research in oncology and pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain assessment and documentation in patients with tumors: theory and reality]. Senn, HJ.[2011]

The GLA:D® Back intervention, which includes patient education and supervised exercises, was successfully implemented in Danish clinics, with positive feedback from clinicians and improved patient outcomes after the program.

Patients enrolled in GLA:D Back showed better or comparable results in pain and disability after implementation compared to those treated before the program, indicating its potential effectiveness in managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLA:D® Back: group-based patient education integrated with exercises to support self-management of persistent back pain - feasibility of implementing standardised care by a course for clinicians. Kongsted, A., Hartvigsen, J., Boyle, E., et al.[2023]

Therapeutic patient education (TPE) is being implemented in Lower Normandy, France, to empower cancer patients in managing their pain through a structured five-stage research program involving caregiver training and patient education.

The program emphasizes evaluating patients' self-efficacy and pain management skills, using specific assessment criteria to measure the effectiveness of TPE, ultimately aiming to improve patients' daily pain management experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Patient Education in Cancer Pain Management: from Practice to Research: Proposals and Strategy of the French EFFADOL Program. Prevost, V., Clarisse, B., Heutte, N., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05843890

NCT05843890 | Tailored Pain Guide (TPG) Study The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference. Detailed ...

2. withpower.com withpower.com/trial/tailored-painguide-for-chronic-lower-back-pain-c8fd8

Tailored PainGuide for Chronic Lower Back Pain This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10403311/

An Interventional Response Phenotyping Study in Chronic ... Evidence-based treatments for chronic low back pain (cLBP) typically work well in only a fraction of patients, and at present there is little guidance ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05843890/tailored-pain-guide-tpg-study

Tailored Pain Guide (TPG) Study | Clinical Research Trial ... This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain.

5. painguide.com painguide.com/pain-conditions/

Pain Conditions | PainGuide | University of Michigan Pain is common in ME/CFS but highly variable in how often and where the pain is present, what it feels like, how severe it is, and what makes it worse.

6. painguide.com painguide.com/

Homepage | PainGuide | University of Michigan An education and self-management resource supporting a patient-centric model of chronic pain care.