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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Physical Therapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Telehealth, Physical therapy, Chronic pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University
  • Intermountain Health Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telehealth Physical Therapy

Arm Description

Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform.

Outcomes

Primary Outcome Measures

Participant Satisfaction with Telehealth Treatment
Survey of participants evaluating treatment satisfaction
Rate of refusal to participate
Ratio of persons entering the study among all those eligibility for enrollment
Rate of enrolled participants initiating telehealth treatment
Ratio of persons attending at least 1 treatment session among all those enrolled
Number of sessions
Number of telehealth physical therapy sessions attended
Change in Oswestry from baseline to 10-weeks
10 item measure of back pain-related disability
Change in Oswestry from baseline to 26-weeks
10 item measure of back pain-related disability
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
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
Change in Pain Intensity from baseline to 10 weeks
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Change in Pain Intensity from baseline to 26 weeks
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
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
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
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
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
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
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
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
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
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
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
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
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
Change in Pain Self-Efficacy Scale from baseline to 10 weeks
10-item measure of confidence in performing activities even with pain
Change in Pain Self-Efficacy Scale from baseline to 26 weeks
10-item measure of confidence in performing activities even with pain

Secondary Outcome Measures

Full Information

First Posted
October 11, 2021
Last Updated
October 20, 2021
Sponsor
University of Utah
Collaborators
Intermountain Health Care, Inc., Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05103462
Brief Title
Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713
Acronym
TeleOPT
Official Title
Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Intermountain Health Care, Inc., Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Telehealth, Physical therapy, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, longitudinal cohort design
Masking
None (Open Label)
Masking Description
The study has only one arm
Allocation
N/A
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Physical Therapy
Arm Type
Experimental
Arm Description
Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Physical Therapy
Intervention Description
Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
Primary Outcome Measure Information:
Title
Participant Satisfaction with Telehealth Treatment
Description
Survey of participants evaluating treatment satisfaction
Time Frame
10-weeks
Title
Rate of refusal to participate
Description
Ratio of persons entering the study among all those eligibility for enrollment
Time Frame
Baseline
Title
Rate of enrolled participants initiating telehealth treatment
Description
Ratio of persons attending at least 1 treatment session among all those enrolled
Time Frame
10-weeks
Title
Number of sessions
Description
Number of telehealth physical therapy sessions attended
Time Frame
10-weeks
Title
Change in Oswestry from baseline to 10-weeks
Description
10 item measure of back pain-related disability
Time Frame
baseline, 10 weeks
Title
Change in Oswestry from baseline to 26-weeks
Description
10 item measure of back pain-related disability
Time Frame
baseline, 26 weeks
Title
Change in Pain Interference from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Pain Interference from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Pain Intensity from baseline to 10 weeks
Description
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Time Frame
baseline, 10 weeks
Title
Change in Pain Intensity from baseline to 26 weeks
Description
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Time Frame
baseline, 26 weeks
Title
Change in Fatigue from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Fatigue from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Sleep Disturbance from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Sleep Disturbance from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Anxiety from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Anxiety from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Depression from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Depression from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Social Role Participation from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Social Role Participation from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Physical Function from baseline to 10 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 10 weeks
Title
Change in Physical Function from baseline to 26 weeks
Description
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Time Frame
baseline, 26 weeks
Title
Change in Pain Self-Efficacy Scale from baseline to 10 weeks
Description
10-item measure of confidence in performing activities even with pain
Time Frame
baseline, 10 weeks
Title
Change in Pain Self-Efficacy Scale from baseline to 26 weeks
Description
10-item measure of confidence in performing activities even with pain
Time Frame
baseline, 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Fritz, PT, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Intermountain Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32393216
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.
Results Reference
background
PubMed Identifier
35667399
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.
Results Reference
derived

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

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