Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of Utah
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Rate of enrolled participants initiating telehealth treatment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Julie Fritz
Distinguished Professor
University of Utah
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Rate of enrolled participants initiating telehealth treatment
Time Frame: 10-weeks
Ratio of persons attending at least 1 treatment session among all those enrolled
Change in Pain Intensity from baseline to 10 weeks
Time Frame: baseline, 10 weeks
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Participant Satisfaction with Telehealth Treatment
Time Frame: 10-weeks
Survey of participants evaluating treatment satisfaction
Rate of refusal to participate
Time Frame: Baseline
Ratio of persons entering the study among all those eligibility for enrollment
Change in Pain Interference from baseline to 26 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 10-weeks
Number of telehealth physical therapy sessions attended
Change in Pain Intensity from baseline to 26 weeks
Time Frame: baseline, 26 weeks
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Change in Anxiety from baseline to 26 weeks
Time Frame: 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
Time Frame: 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
Time Frame: baseline, 10 weeks
10 item measure of back pain-related disability
Change in Oswestry from baseline to 26-weeks
Time Frame: baseline, 26 weeks
10 item measure of back pain-related disability
Change in Fatigue from baseline to 26 weeks
Time Frame: 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 Interference from baseline to 10 weeks
Time Frame: 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 Fatigue from baseline to 10 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: baseline, 10 weeks
10-item measure of confidence in performing activities even with pain