Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713 (TeleOPT)

Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Telehealth Physical Therapy

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Intermountain Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Johns Hopkins University; Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Julie Fritz, PT, PhD, University of Utah

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Chronic pain; Telehealth; Physical therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB_00116150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No