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Completed

NCT Number: NCT05103462

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

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealth Physical Therapy

Behavioral

Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.

Primary outcomes

  1. Participant Satisfaction with Telehealth Treatment

    Time frame: 10-weeks

    Survey of participants evaluating treatment satisfaction

  2. Rate of refusal to participate

    Time frame: Baseline

    Ratio of persons entering the study among all those eligibility for enrollment

  3. Rate of enrolled participants initiating telehealth treatment

    Time frame: 10-weeks

    Ratio of persons attending at least 1 treatment session among all those enrolled

  4. Number of sessions

    Time frame: 10-weeks

    Number of telehealth physical therapy sessions attended

  5. Change in Oswestry from baseline to 10-weeks

    Time frame: baseline, 10 weeks

    10 item measure of back pain-related disability

  6. Change in Oswestry from baseline to 26-weeks

    Time frame: baseline, 26 weeks

    10 item measure of back pain-related disability

  7. Change in Pain Interference from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  8. Change in Pain Interference from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  9. Change in Pain Intensity from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale

  10. Change in Pain Intensity from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale

  11. Change in Fatigue from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  12. Change in Fatigue from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  13. Change in Sleep Disturbance from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  14. Change in Sleep Disturbance from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  15. Change in Anxiety from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  16. Change in Anxiety from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  17. Change in Depression from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  18. Change in Depression from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  19. Change in Social Role Participation from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  20. Change in Social Role Participation from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  21. Change in Physical Function from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  22. Change in Physical Function from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  23. Change in Pain Self-Efficacy Scale from baseline to 10 weeks

    Time frame: baseline, 10 weeks

    10-item measure of confidence in performing activities even with pain

  24. Change in Pain Self-Efficacy Scale from baseline to 26 weeks

    Time frame: baseline, 26 weeks

    10-item measure of confidence in performing activities even with pain

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Intermountain Health Care, Inc.
  • Johns Hopkins University

Registry information

Official study title

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

Acronym: TeleOPT

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 2, 2021
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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