Patient Education for Chronic Low Back Pain

Overseen By Allyn Bove, PhD, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Prior spine surgery, recent orthopaedic surgery, no device access

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized online education can boost confidence in managing chronic low back pain and improve daily function. Participants will complete online questionnaires and engage with educational materials about low back pain over several weeks. This study suits individuals who have experienced low back pain for over 12 weeks, sought medical care for it in the past year, and face a moderate impact on daily activities due to the pain. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance self-management strategies for chronic low back pain.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on education rather than medication changes, so you likely won't need to stop your current meds.

What prior data suggests that this patient education program is safe for individuals with chronic low back pain?

Research has shown that educating patients about chronic low back pain is safe. Several studies have examined Pain Neuroscience Education (PNE), a type of patient education, and found no safety issues or negative effects from the education itself. PNE helps people understand their pain better, which can change their thoughts and feelings about it.

This approach doesn't involve drugs or medical procedures; it focuses on learning and understanding. Because it's educational, it generally poses no physical risks. Participants in earlier studies did not report any negative side effects from the education. This suggests that personalized education materials for chronic low back pain are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on patient education as a treatment for chronic low back pain, offering an innovative approach compared to conventional methods like medication and physical therapy. Unlike standard treatments that often involve drugs or intensive physical regimens, this approach empowers patients by providing them with online educational materials to manage their pain effectively. This method is unique because it is accessible, easy to implement, and encourages patients to take an active role in their own care, potentially leading to better long-term outcomes. By emphasizing education and self-management, researchers hope to find out if this can be a more sustainable and less invasive way to alleviate chronic low back pain.

What evidence suggests that this patient education program is effective for chronic low back pain?

Research has shown that teaching patients about pain, particularly through pain neuroscience education (PNE), can reduce chronic low back pain and improve functionality. In this trial, participants will access online educational materials as part of Patient Education for Chronic Low Back Pain. Studies have found that combining PNE with exercise or physical therapy enhances pain management and daily activities. For instance, one review found that PNE, especially when paired with other treatments, significantly reduces pain and disability in individuals with chronic low back pain. These programs focus on educating patients about pain and consistently show positive effects on both pain levels and patient management of their condition. Overall, personalized education programs are promising tools for boosting confidence and reducing the impact of chronic low back pain on daily life. ^{6 7 8 9 10}

Who Is on the Research Team?

Allyn Bove, PhD, PT, DPT

Principal Investigator

University of Pittsburgh

Yanshan Wang, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals suffering from chronic low back pain. Participants should be willing to engage with online educational materials and complete questionnaires about their condition before and after the education program.

Inclusion Criteria

I have had chronic low back pain for more than 12 weeks.

Patients who receive care outside of UPMC: The potential participant can provide a physician letter, after visit summary, or other reasonable documentation to confirm that they have indeed sought health care for LBP within the previous 12 months

My back pain is bad enough to score 15 or more on a disability test.

Exclusion Criteria

Does not have own smartphone, tablet, laptop, or desktop to access study questionnaires and education materials

I have not had any bone surgery in the last 6 months.

I have had surgery on my spine before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Educational Intervention

Participants complete a 3-week educational intervention aimed at improving self-efficacy in managing chronic low back pain. Educational materials are personalized and accessed online on days 5, 8, 11, 14, and 17.

3 weeks

5 online sessions

Follow-up

Participants complete online follow-up responses to baseline questionnaires and a post-study survey to assess changes in pain and self-efficacy.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Patient Education for Chronic Low Back Pain

Trial Overview The study is testing a personalized patient education program designed to improve self-confidence in managing chronic low back pain and reduce perceived disability due to the condition. It involves following an online educational course over several days.

How Is the Trial Designed?

Group I: Patient Education for Chronic Low Back Pain Experimental Treatment 1 Intervention

Patients will access online patient education materials on chronic low back pain five times after completing baseline questionnaires on days 5, 8, 11, 14, and 17.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Pain neuroscience education (PNE) combined with exercise or physiotherapy significantly reduces short-term pain and disability in patients with chronic low back pain, based on a review of 17 studies involving 1078 participants.

Longer PNE sessions (over 60 minutes) and group-based approaches appear to enhance the effectiveness of PNE, suggesting that the duration and format of education are important factors in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: short-term outcomes of pain and disability. Ma, X., Chen, R., Li, W., et al.[2023]

Pain neuroscience education (PNE) effectively reduces kinesiophobia and improves illness perceptions in chronic spinal pain patients, regardless of their level of education, based on a study of 120 participants.

While there were no significant differences in overall effectiveness between higher and lower educated patients, the higher educated group showed notable improvements in specific areas like perceived illness cyclicity, indicating that PNE can be beneficial across different educational backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of education level on the effectiveness of pain neuroscience education: A secondary analysis of a randomized controlled trial. Bilterys, T., Kregel, J., Nijs, J., et al.[2022]

In a study of 40 patients with chronic low back pain, combining Pain Neuroscience Education (PNE) with kinesiotherapy significantly improved pain perception and reduced kinesiophobia compared to kinesiotherapy alone.

The intervention group that received PNE showed notable improvements across all evaluated variables, indicating that educating patients about pain can enhance the effectiveness of physical therapy in managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapeutic treatment associated with the pain neuroscience education for patients with chronic non-specific low back pain-single-blind randomized pilot clinical trial. Yamada, AS., Antunes, FTT., Vaz, SMR., et al.[2023]

Pain neuroscience education (PNE) combined with physiotherapy shows moderate evidence of improving short-term disability and pain in patients with chronic low back pain (CLBP), based on a meta-analysis of 8 trials involving 615 participants.

While PNE appears effective in the short term, the analysis did not find evidence of long-term benefits for pain or disability when PNE was added to standard physiotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Wood, L., Hendrick, PA.[2019]

Pain neuroscience education (PNE) is an effective educational strategy for managing persistent low back pain (PLBP), helping patients shift their understanding of pain from a focus on tissue injury to a neurobiological perspective.

The systematic review identified 54 relevant studies and highlighted that PNE aims to enhance patient adherence to rehabilitation by normalizing cognitive-behavioral responses, distinguishing it from traditional educational methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clarification of the "pain neuroscience education" concept in the management of patients with persistent low back pain: A scoping review. Adenis, N., Gosselin, K., Stetsenko, N., et al.[2023]

This study will evaluate the effectiveness of Pain Neuroscience Education (PNE) in real-world clinical settings by training clinicians in 16 clinic regions to provide PNE to patients with chronic neck or back pain, with outcomes measured at baseline, 2 weeks, and 12 weeks.

PNE aims to change patients' understanding of pain from a damage indicator to a brain interpretation of signals, potentially offering a low-cost intervention that could improve physical therapy education and patient outcomes for chronic spinal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of training physical therapists in pain neuroscience education on patient reported outcomes for patients with chronic spinal pain: a study protocol for a cluster randomized controlled trial. Lane, E., Fritz, JM., Greene, T., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37395152/

A systematic review and meta-analysis of pain ... This review aims to investigate the effect of PNE alone and combined with physical therapy or exercise for chronic LBP.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1877065725000855

The effectiveness of pain neuroscience education in ... Pain neuroscience education reduces chronic non-specific low back pain. •. Its combination with exercise or physiotherapy enhances clinical results. •.

3. iasp-pain.org iasp-pain.org/publications/relief-news/article/pain-neuroscience-education-back-pain/

Pain neuroscience education: Effects on pain and disability ... Aquatic exercise and pain neurophysiology education versus aquatic exercise alone for patients with chronic low back pain: a randomized controlled trial.

4. withpower.com withpower.com/trial/phase-chronic-lower-back-pain-clbp-7-2024-d389d

Patient Education for Chronic Low Back Pain The studies focus on the effectiveness of PNE in improving pain and disability outcomes, but they do not address safety concerns or adverse effects. Therefore, ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/6/e080079

Effectiveness of a pain neuroscience education ... Our study aims to assess the effectiveness of a pain neuroscience education programme compared with traditional back school on physical activity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11149160/

Effectiveness of a pain neuroscience education programme ... Our study aims to assess the effectiveness of a pain neuroscience education programme compared with traditional back school on physical activity.

7. physio-pedia.com physio-pedia.com/Pain_Neuroscience_Education_(PNE)_for_Low_Back_Pain

Pain Neuroscience Education (PNE) for Low Back Pain Pain Neuroscience Education (PNE) is a strategy that aims to teach patients to reshape their mindset and perception of pain despite these factors.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0309679

A study protocol for a single-blind randomized controlled trial Pain Neuroscience Education (PNE) helps patients better understand their pain from biological and physiological perspectives, which clinicians ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04179708?tab=table

Effectiveness of Pain Neuroscience Education Compared ... Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain : A Randomized Monocentric Trial.

10. medrxiv.org medrxiv.org/content/10.1101/2023.09.18.23295477v1

Effectiveness of a Pain Neuroscience Education program ... Our study aims to measure the effectiveness of a pain neuroscience education compared to a back school on physical activity three months and one year after ...