Recruiting

Telerehabilitation

Sponsor:

Johns Hopkins University

Code:

NCT06821607

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

In-Clinic Physical Therapy

Telehealth Physical Therapy (Telerehabilitation)

Study Details

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

Study ID

NCT06821607

Start date

Apr 1, 2025

Status verified date

Aug, 2026

Completion date

May 1, 2030

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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 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.

Interventions

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.

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.

Primary outcome measure

  • Change in Oswestry Disability Index [ Time Frame: Change from baseline to 3 months after treatment initiation ]

Central Contacts and Locations

Central contacts

Richard L Skolasky, Sc.D.

410-502-7975rskolas1@jhmi.edu

Kevin McLaughlin, D.P.T.

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

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Richard L Skolasky, Sc.D.

410-502-7975rskolas1@jhmi.edu

Principal Investigator:

Richard L Skolasky, Sc.D.

Intermountain Healthcare

Recruiting

Salt Lake City, Utah, United States, 84111

Contacts

Kate Minick, P.T., D.P.T., Ph.D.

Kate.minick@imail.org

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Julie M Fritz, Ph.D., P.T., ATC

Julie.fritz@utah.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • chronic low back pain
  • physical therapy
  • telehealth
  • telerehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-21.