Telerehabilitation for Lower Back Pain

(ARBOR-Th Trial)

Recruiting at 1 trial location

Overseen By Kevin McLaughlin, D.P.T

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Recent lumbar surgery, Pregnancy, Serious pathology, Neurological disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

434 Participants Needed

Trial Summary

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Telerehabilitation for Lower Back Pain?

Research shows that telerehabilitation can effectively manage chronic low back pain by providing remote access to therapy, which is especially beneficial for those in low-resource areas. Studies indicate that telerehabilitation is as effective as traditional clinic-based therapy in reducing pain and improving health outcomes. ^{1 2 3 4 5}

Is telerehabilitation safe for humans?

Telerehabilitation is generally considered safe for humans, as it allows remote access to medical treatments and ongoing monitoring, which can be beneficial for patients, especially those in remote areas. ^{1 2 3 6 7}

How does the treatment Telerehabilitation differ from other treatments for lower back pain?

Telerehabilitation is unique because it allows patients to receive treatment remotely, making it accessible for those who are physically or economically disadvantaged. It facilitates multidisciplinary management and provides the opportunity for early intervention, ongoing monitoring, and cost savings, especially in low-resource areas. ^{1 2 5 7 8}

What is the purpose of this trial?

Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-informed telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.

Research Team

Richard Skolasky, ScD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for people with chronic lower back pain (LBP) who live in rural areas and have trouble accessing physical therapy due to provider availability, transportation issues, or work conflicts. Participants should be willing to engage in telerehabilitation.

Inclusion Criteria

Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis

Can speak and understand English

Access to video-enabled device and Internet

Exclusion Criteria

My lower back pain is caused by a serious health condition.

I had lumbar spine surgery in the last 6 months.

Knowingly pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive risk-informed telerehabilitation or educational control for 8 weeks

8 weeks

Follow-up

Participants are monitored for changes in LBP-related disability and opioid use

12 weeks

Long-term Follow-up

Participants are monitored for changes in physical function and healthcare use

52 weeks

Treatment Details

Interventions

• Telerehabilitation

Trial Overview The study tests the effectiveness of telerehabilitation—a way to do physical therapy over the internet—against standard educational materials for managing chronic LBP. It will also see if matching patients with specific types of telehealth visits based on their psychological risk improves outcomes.

Participant Groups

Group I: Telerehabilitation Experimental Treatment 1 Intervention

Based on prior STarT Back Tool (SBTS) screening risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to psychological informed physical therapy (PIPT) telehealth visits (high-risk). The SBTS is a short questionnaire that assesses an individual's physical, psychosocial, and psychological risk factors for chronic back pain that can be improved with treatment.

Group II: Standardized Education Active Control 1 Intervention

Patients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest. To promote increased physical activity levels, the website will also include pictures and videos of common exercises targeting the lumbopelvic region that patients can perform independently without the need for exercise equipment.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Tidalhealth, Inc.

Collaborator

Trials

2

Recruited

560+

Maryland Rural Health Association

Collaborator

Trials

1

Recruited

430+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

Telerehabilitation (TR) is an effective approach for managing low back pain (LBP), particularly in low and middle-income countries where access to healthcare may be limited.

TR offers significant benefits such as improved patient interaction, remote access to treatments, and timely monitoring, which can lead to early pain management and reduced healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtually Administered Intervention Through Telerehabilitation for Chronic Non-specific Low Back Pain: A Review of Literature. Mehendale, P., Iyenagar, M., Bhatt, G., et al.[2023]

Telerehabilitation-based McKenzie therapy (TBMT) was found to be more cost-effective than clinic-based McKenzie therapy (CBMT) for treating nonspecific chronic low back pain (NCLBP), with lower costs per patient (22,200 naira vs. 38,200 naira) and slightly higher quality-adjusted life years (QALY) gained (0.085 vs. 0.084).

The study, involving 47 participants over 8 weeks, indicated that TBMT not only provided similar clinical benefits but also resulted in cost savings, suggesting it could be a viable alternative for managing NCLBP, especially for those with limited access to traditional healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. Fatoye, F., Gebrye, T., Fatoye, C., et al.[2023]

Physical therapists believe that web-based telerehabilitation can effectively treat chronic low back pain (CLBP) by allowing for greater patient engagement and follow-up, but success depends on patients actively participating in their treatment.

While new technologies can expand access to therapy and reduce healthcare costs, there are challenges in ensuring that exercise programs are tailored to individual patient preferences and that patients understand the correct techniques for long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain. Martínez de la Cal, J., Fernández-Sánchez, M., Matarán-Peñarrocha, GA., et al.[2021]

Telerehabilitation-Based McKenzie Therapy (TBMT) is as effective as Clinic-Based McKenzie Therapy (CBMT) in managing chronic low-back pain, with significant improvements in pain intensity, muscle endurance, activity limitation, participation restriction, and general health status over an 8-week period involving 47 patients.

The TBMT group reported significantly higher vitality scores in general health status compared to the CBMT group, suggesting that the mobile app platform may enhance certain aspects of patient well-being while providing comparable clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. Mbada, CE., Olaoye, MI., Dada, OO., et al.[2020]

A study involving 50 individuals with chronic low back pain showed that video-based telerehabilitation significantly improved pain, function, quality of life, and patient satisfaction after 8 weeks compared to conventional rehabilitation methods.

Participants using the telerehabilitation software reported greater motivation and adherence to their rehabilitation program, indicating that this approach may enhance the effectiveness of home exercise management for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of video exercise-based telerehabilitation on clinical outcomes, expectation, satisfaction, and motivation in patients with chronic low back pain. Özden, F., Sarı, Z., Karaman, ÖN., et al.[2022]

A randomized clinical trial with 56 patients showed that remote exercise instruction and in-person exercise instruction for low back pain resulted in similar improvements in pain and disability after 12 weeks.

Both methods involved core stability exercises, and the lack of significant differences (p = 0.93 for pain and p = 0.74 for disability) suggests that remote exercise programs can be as effective as in-person sessions for managing nonspecific low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Versus in-Person Exercise Instruction for Chronic Nonspecific Low Back Pain Lasting 12 Weeks or Longer: A Randomized Clinical Trial. Dadarkhah, A., Rezaimoghadam, F., Najafi, S., et al.[2021]

A mobile-based telerehabilitation (TLRH) program was found to be as effective as traditional clinical exercise programs in improving disability, pain intensity, and hip strength in patients with non-specific low back pain (NLBP), based on a study involving 71 participants over 8 weeks.

Significant improvements were observed in hip strength and reductions in pain and pain catastrophizing, indicating that TLRH can be a viable alternative to in-person treatment for managing NLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In non-specific low back pain, is an exercise program carried out through telerehabilitation as effective as one carried out in a physiotherapy center? A controlled randomized trial. Villatoro-Luque, FJ., Rodríguez-Almagro, D., Aibar-Almazán, A., et al.[2023]

A telerehabilitation (TLRH) program delivered through a mobile app was found to be as effective as a traditional supervised clinical exercise program for improving pain and functional outcomes in patients with chronic nonspecific low back pain, based on a study of 68 participants over 8 weeks.

Significant improvements were observed in the range of motion and pain intensity, particularly during specific movements, indicating that TLRH can be a viable alternative for managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation for the treatment in chronic low back pain: A randomized controlled trial. Villatoro-Luque, FJ., Rodríguez-Almagro, D., Aibar-Almazán, A., et al.[2023]

References

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

Virtually Administered Intervention Through Telerehabilitation for Chronic Non-specific Low Back Pain: A Review of Literature. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain. [2021]

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

Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

The effect of video exercise-based telerehabilitation on clinical outcomes, expectation, satisfaction, and motivation in patients with chronic low back pain. [2022]

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

Remote Versus in-Person Exercise Instruction for Chronic Nonspecific Low Back Pain Lasting 12 Weeks or Longer: A Randomized Clinical Trial. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

In non-specific low back pain, is an exercise program carried out through telerehabilitation as effective as one carried out in a physiotherapy center? A controlled randomized trial. [2023]

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

Telerehabilitation for the treatment in chronic low back pain: A randomized controlled trial. [2023]