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

NCT05103462 | Completed

• 1 other identifier: IRB_00116150
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Keywords

Telehealth; Physical therapy; Chronic pain

Outcome Measures

Primary Outcomes (24)

• 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

Study Arms (1)

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.

Behavioral: Telehealth Physical Therapy

Interventions

Telehealth Physical Therapy BEHAVIORAL

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

Telehealth Physical Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Intermountain Health Care, Inc.: collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Intermountain Health Care

Salt Lake City, Utah, 84107, United States

Location

Related Publications (2)

• 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.

  PMID: 32393216 BACKGROUND

• 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.

  PMID: 35667399 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Fritz, PT, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study has only one arm
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: Prospective, longitudinal cohort design

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 2, 2021
• Study Start: August 18, 2020
• Primary Completion: December 18, 2020
• Study Completion: August 13, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (2)