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

ConditionChronic Low Back Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-64

SponsorJohns Hopkins University

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: In-Clinic Physical TherapyActive comparator 1 intervention

Group B: Telehealth Physical Therapy (Telerehabilitation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Oswestry Disability Index

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

Time frame

Change from baseline to 3 months after treatment initiation

Secondary outcomes

Back Pain Numeric Rating Scale (NRS)

Scale of 0-10 with 0 indicating no pain and 10 indicating worst possible pain.

Time frame

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

Change in PROMIS Pain Interference (PI)

Total score range is \[0, 100\] with higher scores indicating better outcome.

Time frame

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

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

Physical function. The total score range is \[0, 100\] with higher scores indicating better physical function.

Time frame

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

Change in PROMIS Pain Interference (PI) by Gender

Total score range is \[0, 100\] with higher scores indicating better outcome.

Time frame

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

Other outcomes

Number of physical therapy sessions attended

Implementation - Acceptability as assessed by number of physical therapy session attended

Time frame

3 months after treatment initiation

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

University of Utah

Collaborator

Intermountain Health Care, Inc.

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

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