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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
| Johns Hopkins University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Physical Therapy | Experimental | Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Physical Therapy | Behavioral | Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Fritz, PT, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Intermountain Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32393216 | Background | Skolasky RL, Wegener ST, Aaron RV, Ephraim P, Brennan G, Greene T, Lane E, Minick K, Hanley AW, Garland EL, Fritz JM. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z. | |
| 38157307 |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Prospective, longitudinal cohort design
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The study has only one arm
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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 |
| Salt Lake City |
| Utah |
| 84107 |
| United States |
| McLaughlin KH, Fritz JM, Minick KI, Brennan GP, McGee T, Lane E, Thackeray A, Bardsley T, Wegener ST, Hunter SJ, Skolasky RL. Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain. Phys Ther. 2024 Mar 1;104(3):pzad180. doi: 10.1093/ptj/pzad180. |
| 35667399 | Derived | Fritz JM, Minick KI, Brennan GP, McGee T, Lane E, Skolasky RL, Thackeray A, Bardsley T, Wegener ST, Hunter SJ. Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. Arch Phys Med Rehabil. 2022 Oct;103(10):1924-1934. doi: 10.1016/j.apmr.2022.04.016. Epub 2022 Jun 3. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |