Clinical trial NCT05103462: Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713
Official title: Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Telehealth
Physical therapy
Chronic pain
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
name: Johns Hopkins University
First posted: 2021-11-02
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, longitudinal cohort design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Participant Satisfaction with Telehealth Treatment
timeFrame: 10-weeks
measure: Rate of refusal to participate
timeFrame: Baseline
measure: Rate of enrolled participants initiating telehealth treatment
timeFrame: 10-weeks
measure: Number of sessions
timeFrame: 10-weeks
measure: Change in Oswestry from baseline to 10-weeks
timeFrame: baseline, 10 weeks
measure: Change in Oswestry from baseline to 26-weeks
timeFrame: baseline, 26 weeks
measure: Change in Pain Interference from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Pain Interference from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Pain Intensity from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Pain Intensity from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Fatigue from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Fatigue from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Sleep Disturbance from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Sleep Disturbance from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Anxiety from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Anxiety from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Depression from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Depression from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Social Role Participation from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Social Role Participation from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Physical Function from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Physical Function from baseline to 26 weeks
timeFrame: baseline, 26 weeks
measure: Change in Pain Self-Efficacy Scale from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Pain Self-Efficacy Scale from baseline to 26 weeks
timeFrame: baseline, 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Salt Lake City
country: United States
facility: Intermountain Health Care
state: Utah
Study officials:
affiliation: University of Utah
name: Julie Fritz, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.