Telerehabilitation for Low Back Pain

(TeleBACK Trial)

Recruiting at 2 trial locations

Overseen By Kevin McLaughlin, D.P.T.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Lumbar surgery, Pregnancy, Serious pathology, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization. The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.

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.

Is telerehabilitation for low back pain safe for humans?

Research suggests that telerehabilitation, including telehealth physical therapy, is generally safe for humans. Safety measures, such as therapist-led sessions and monitoring, are used to prevent adverse events during telerehabilitation exercises. ^{1 2 3 4 5}

How does telerehabilitation for low back pain differ from other treatments?

Telerehabilitation for low back pain is unique because it allows patients to receive physical therapy remotely through videoconferencing, making it accessible for those who are physically or economically disadvantaged. This approach can facilitate multidisciplinary management and provide ongoing support and monitoring, which may not be as easily achieved with traditional in-clinic therapy. ^{1 3 6 7 8}

What data supports the effectiveness of telerehabilitation for low back pain treatment?

Research shows that telerehabilitation, which uses technology to deliver physical therapy remotely, can be as effective as traditional in-clinic therapy for managing low back pain. Studies found that both methods significantly improved pain intensity, muscle endurance, and overall health, with no major differences in outcomes, suggesting that telerehabilitation is a viable alternative to in-person therapy. ^{1 2 3 6 9}

Who Is on the Research Team?

Richard L. Skolasky, Sc.D.

Principal Investigator

Johns Hopkins University

Kevin McLaughlin, D.P.T.

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

The TeleBACK Clinical Trial is for individuals with chronic low back pain seeking outpatient care. Participants will be randomly assigned to receive either in-clinic physical therapy or telerehabilitation, which is physical therapy via video-visits.

Inclusion Criteria

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

I have been diagnosed with chronic lower back pain.

I experience moderate to severe pain and disability.

Exclusion Criteria

My low back pain is not due to muscle or bone issues.

Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder

Knowingly pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive 8 sessions of physical therapy, either in-clinic or via telerehabilitation, over a period of 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• In-Clinic Physical Therapy
• Telehealth Physical Therapy (Telerehabilitation)

Trial Overview This trial tests the effectiveness of telehealth physical therapy compared to traditional in-clinic physical therapy for chronic low back pain. It also examines patient engagement and impact on healthcare utilization related to lower back pain.

How Is the Trial Designed?

Group I: Telehealth Physical Therapy (Telerehabilitation) Experimental Treatment 1 Intervention

Those randomized to telerehabilitation will receive all PT care, including the initial evaluation and 7 follow-up sessions, via real-time video conferencing technology. Like the interventions provided to those receiving in-clinic PT, treatments provided in the telerehabilitation group will be consistent with evidence-based guidelines, adapted for delivery via real-time video visits. Consistent with the in-clinic group, specific interventions will be selected by the treating physical therapist based on patients' symptoms, examination findings, and preferences and goals. There will be an emphasis: Open-ended questions to allow patients to describe impairments and limitations; Review patient-reported measures of disability and pain intensity to help identify functional impairments; and Clinical examination of spinal movements and impairments in strength, flexibility, and joint mobility.

Group II: In-Clinic Physical Therapy Active Control 1 Intervention

Patients in this group will receive all PT sessions in-clinic with a trained physical therapist. Treatment provided for this group will be consistent with evidence-based guidelines that recommend patient education, exercise instruction, manual therapy interventions, and psychosocial interventions. Specific interventions to be provided within each of these categories: Education, Exercise, Manual Therapy, and Psychosocial interventions. Components of the intervention will be determined by the treating therapist based on patients' symptoms, examination findings, and patients' preferences and goals.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Intermountain Health Care, Inc.

Collaborator

Trials

142

Recruited

1,965,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A telehealth physical therapy program for chronic low back pain was feasible and well-received by participants, with 69.8% initiating the program and significant improvements in disability and pain reported at follow-ups.

Participants generally expressed satisfaction with telehealth PT, although only 39.5% felt it matched the quality of in-person therapy, highlighting areas for improvement in the telehealth experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. Fritz, JM., Minick, KI., Brennan, GP., et al.[2022]

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]

A study involving 31 participants with chronic low back pain showed that telehealth physical therapy (PT) is generally well-received, with many participants reporting positive experiences and advantages such as convenience and cost savings.

However, concerns about the quality of telehealth compared to in-person therapy persisted for some, highlighting the need for improvements like a hybrid approach that combines both methods and offers technical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey. Skolasky, RL., Kimball, ER., Galyean, P., et al.[2022]

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]

In a study of 1090 participants with low back pain, clinic-based multidisciplinary therapy (C-IPU) resulted in significantly greater pain relief and reductions in disability compared to web-based therapy (O-IPU).

Both treatment approaches effectively reduced opioid use, with 19% of C-IPU and 21.5% of O-IPU participants ceasing opioid use by the end of treatment, highlighting the effectiveness of both methods in managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model. Raiszadeh, K., Tapicer, J., Taitano, L., et al.[2021]

A scoping review of 107 studies involving 3991 participants with stroke found that safety measures during asynchronous telerehabilitation exercises are rarely reported, with only 10 studies detailing such measures.

Common safety strategies included assessing exercise locations, using seated positions, and implementing live warning systems to prevent risky exercises, highlighting the need for more comprehensive reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. Gutierrez-Arias, R., González-Mondaca, C., Marinkovic-Riffo, V., et al.[2023]

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]

Citations

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

Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey. [2022]

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. Canada pubmed.ncbi.nlm.nih.gov

In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model. [2021]

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

Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain. [2023]

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

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. [2023]

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

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

9. 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]