TeleOPT: Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telehealth Physical Therapy 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
Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 - 64 years at the time of enrollment.
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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.
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Healthcare visit for LBP in the past 90 days.
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At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4.
Exclusion Criteria:
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Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
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Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc.
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Knowingly pregnant
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Unable to participate in telehealth due to lack of technology or internet access
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Has received physical therapy for LBP in prior 90 days
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Currently receiving substance use disorder treatment
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Any lumbar spine surgery in the past year.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
| 2 | Intermountain Health Care | Salt Lake City | Utah | United States | 84107 |
Sponsors and Collaborators
- University of Utah
- Intermountain Health Care, Inc.
- Johns Hopkins University
Investigators
- Principal Investigator: Julie Fritz, PT, PhD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
- IRB_00116150