Low Back Pain
Conditions
Keywords
Telehealth, Physical therapy, Chronic pain
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.
Interventions
BEHAVIORALTelehealth Physical Therapy
Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
Sponsors
Intermountain Health Care, Inc.
Johns Hopkins University
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The study has only one arm
Intervention model description
Prospective, longitudinal cohort design
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of enrolled participants initiating telehealth treatment | 10-weeks | Ratio of persons attending at least 1 treatment session among all those enrolled |
| Number of sessions | 10-weeks | Number of telehealth physical therapy sessions attended |
| 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 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 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 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 |
| 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 |
| 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 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 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 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 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 |
| 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 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 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 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 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 10 weeks | baseline, 10 weeks | 10-item measure of confidence in performing activities even with pain |
| 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 |
Countries
United States
Outcome results
None listed