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

NCT06821607 | Recruiting DMC

• 1 other identifier: IRB00460142
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

chronic low back pain; physical therapy; telehealth; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index

  LBP-related disability. The total score range is \[0, 100\] with higher values representing greater pain-related disability.

  Change from baseline to 3 months after treatment initiation

Secondary Outcomes (14)

• Back Pain Numeric Rating Scale (NRS)

  Change from baseline to 3-, 6-, and 12- months after treatment initiation

• Change in PROMIS Pain Interference (PI)

  Change from baseline to 3-, 6-, and 12-months after treatment initiation

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function

  Change from baseline to 3-, 6-, and 12- months after treatment initiation

• Change in PROMIS Pain Interference (PI) by Gender

  Change from baseline to 3-, 6-, and 12-months after treatment initiation

• Change in PROMIS Pain Interference (PI) by Age Group

  Change from baseline to 3-, 6-, and 12-months after treatment initiation

Other Outcomes (4)

• Percent of patients approached who accept participation

  At screening

• Percent of patients offered telerehabilitation

  At screening

• Percent of intervention sessions completed

  3 months after treatment initiation

Study Arms (2)

In-Clinic Physical Therapy

ACTIVE COMPARATOR

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: In-Clinic Physical Therapy

Telehealth Physical Therapy (Telerehabilitation)

EXPERIMENTAL

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.

Behavioral: Telehealth Physical Therapy (Telerehabilitation)

Interventions

In-Clinic Physical Therapy BEHAVIORAL

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.

In-Clinic Physical Therapy

Telehealth Physical Therapy (Telerehabilitation) BEHAVIORAL

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.

Telehealth Physical Therapy (Telerehabilitation)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis.
• At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
• Meets NIH Task Force2 definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem? and 2) How often has LBP been an ongoing problem over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
• Can speak and understand English or Spanish (Utah sites only).

You may not qualify if:

• Recent history (last 6 months) of lumbar spine surgery.
• Possible non-musculoskeletal cause for low back pain symptoms (e.g., pregnancy).
• Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
• Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder.
• Knowingly pregnant

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Utah: collaborator
• Intermountain Health Care, Inc.: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Intermountain Healthcare

Salt Lake City, Utah, 84111, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Richard L. Skolasky, Sc.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Kevin McLaughlin, D.P.T.

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard L Skolasky, Sc.D.

CONTACT

410-502-7975; rskolas1@jhmi.edu

Kevin McLaughlin, D.P.T.

CONTACT

410-614-3234; kevin.mclaughlin@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after final dataset is closed, curated, and uploaded to the data sharing platform. Data will be available in perpetuity.
• Access Criteria: Data will be accessible on a closed-access basis. Researchers will have to request access and have this request be approved.

Locations

US (3)