1000 Participants Needed

Telerehabilitation for Low Back Pain

(TeleBACK Trial)

Recruiting at 2 trial locations
RL
KM
Overseen ByKevin McLaughlin, D.P.T.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13678

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.12369

Who Is on the Research Team?

RL

Richard L. Skolasky, Sc.D.

Principal Investigator

Johns Hopkins University

KM

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.
See 1 more

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
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth Physical Therapy (Telerehabilitation)Experimental Treatment1 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 TherapyActive Control1 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.

Find a Clinic Near You

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.
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.
Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain.Martรญnez de la Cal, J., Fernรกndez-Sรกnchez, M., Matarรกn-Peรฑarrocha, 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.
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]

Citations

Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. [2022]
Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain. [2021]
Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey. [2022]
Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. [2020]
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]
Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain. [2023]
Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. [2023]
Virtually Administered Intervention Through Telerehabilitation for Chronic Non-specific Low Back Pain: A Review of Literature. [2023]
The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. [2023]
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