Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713

Study Overview
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Brief Summary
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This study evaluated the feasibility of an 8-week physical therapy program for persons with chronic low back pain provided entirely using telehealth with real-time, interactive video sessions with a physical therapist.

Detailed Description
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At the time of the onset of the COVID pandemic, the research team was conducting a clinical trial (the OPTIMIZE trial) investigating different nonpharmacologic treatments for persons with chronic low back pain (NCT03859713). One intervention arm in this trial is in-person physical therapy. COVID-related restrictions on in-person care prompted suspension of the OPTIMIZE trial. In order to accommodate persons in the midst of receiving treatment at the time of suspension, the study team adapted the in-person protocol for physical therapy for telehealth delivery using two-way, real-time video sessions. Because of the lack of research examining the feasibility of telehealth physical therapy provided in this manner, the study team decided to conduct a pilot study to examine the feasibility of the telehealth protocol. This study was a prospective, longitudinal cohort of persons with chronic LBP seeking care in one of three healthcare systems; University of Utah Health and Intermountain Healthcare in Salt Lake City, Utah, and Johns Hopkins Medicine in Baltimore, Maryland. All participants were offered up to 8 weekly sessions of telehealth physical therapy. Outcomes included measures of acceptability, appropriateness, feasibility and fidelity as well as effectiveness measures including the Oswestry Disability Index and the PROMIS-29 health domains. Assessments occurred at baseline and after 10- and 26-weeks.

Official Title
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Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Telehealth Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 64 years at the time of enrollment. Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you 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. Healthcare visit for LBP in the past 90 days. At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4. Exclusion Criteria: Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc. Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc. Knowingly pregnant Unable to participate in telehealth due to lack of technology or internet access Has received physical therapy for LBP in prior 90 days Currently receiving substance use disorder treatment Any lumbar spine surgery in the past year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, longitudinal cohort design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Physical Therapy<br>Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform. | Behavioral: Telehealth Physical Therapy<br>* Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction with Telehealth Treatment | Survey of participants evaluating treatment satisfaction | 10-weeks | 
| Rate of refusal to participate | Ratio of persons entering the study among all those eligibility for enrollment | Baseline | 
| Rate of enrolled participants initiating telehealth treatment | Ratio of persons attending at least 1 treatment session among all those enrolled | 10-weeks | 
| Number of sessions | Number of telehealth physical therapy sessions attended | 10-weeks | 
| Change in Oswestry from baseline to 10-weeks | 10 item measure of back pain-related disability | baseline, 10 weeks | 
| Change in Oswestry from baseline to 26-weeks | 10 item measure of back pain-related disability | baseline, 26 weeks | 
| Change in Pain Interference from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Pain Interference from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Pain Intensity from baseline to 10 weeks | PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale | baseline, 10 weeks | 
| Change in Pain Intensity from baseline to 26 weeks | PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale | baseline, 26 weeks | 
| Change in Fatigue from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Fatigue from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Sleep Disturbance from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Sleep Disturbance from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Anxiety from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Anxiety from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Depression from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Depression from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Social Role Participation from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Social Role Participation from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Physical Function from baseline to 10 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 10 weeks | 
| Change in Physical Function from baseline to 26 weeks | PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10 | baseline, 26 weeks | 
| Change in Pain Self-Efficacy Scale from baseline to 10 weeks | 10-item measure of confidence in performing activities even with pain | baseline, 10 weeks | 
| Change in Pain Self-Efficacy Scale from baseline to 26 weeks | 10-item measure of confidence in performing activities even with pain | baseline, 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Physical therapy, Chronic pain