Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

Summary

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.

Conditions

• Chronic Low Back Pain

Interventions

BEHAVIORAL

In-Clinic Physical Therapy

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.

BEHAVIORAL

Telehealth Physical Therapy (Telerehabilitation)

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 the participant's 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.

Sponsors & Collaborators

• University of Utah

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Richard L. Skolasky, Sc.D. · Johns Hopkins University

• Kevin McLaughlin, D.P.T. · Johns Hopkins School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2029-09-30

Completion

2030-05-01

Countries

• United States

Study Locations