Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713
- Conditions
- Low Back Pain
- Interventions
- Behavioral: Telehealth Physical Therapy
- Registration Number
- NCT05103462
- Lead Sponsor
- University of Utah
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Telehealth Physical Therapy Telehealth Physical Therapy Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform.
- Primary Outcome Measures
Name Time Method Change in Pain Intensity from baseline to 26 weeks baseline, 26 weeks PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Rate of enrolled participants initiating telehealth treatment 10-weeks Ratio of persons attending at least 1 treatment session among all those enrolled
Change in Pain Intensity from baseline to 10 weeks baseline, 10 weeks PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Participant Satisfaction with Telehealth Treatment 10-weeks Survey of participants evaluating treatment satisfaction
Rate of refusal to participate Baseline Ratio of persons entering the study among all those eligibility for enrollment
Change in Pain Interference from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Sleep Disturbance from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Anxiety from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Number of sessions 10-weeks Number of telehealth physical therapy sessions attended
Change in Anxiety from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Physical Function from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Oswestry from baseline to 10-weeks baseline, 10 weeks 10 item measure of back pain-related disability
Change in Oswestry from baseline to 26-weeks baseline, 26 weeks 10 item measure of back pain-related disability
Change in Fatigue from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Fatigue from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Pain Interference from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Social Role Participation from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Sleep Disturbance from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Depression from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Depression from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Social Role Participation from baseline to 10 weeks baseline, 10 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Physical Function from baseline to 26 weeks baseline, 26 weeks PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Pain Self-Efficacy Scale from baseline to 26 weeks baseline, 26 weeks 10-item measure of confidence in performing activities even with pain
Change in Pain Self-Efficacy Scale from baseline to 10 weeks baseline, 10 weeks 10-item measure of confidence in performing activities even with pain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Intermountain Health Care
🇺🇸Salt Lake City, Utah, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States