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

Low Back Pain Clinical Trial

— TeleOPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103462
• Other study ID #: IRB_00116150
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: August 13, 2021

Study information

• Verified date: October 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 13, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Telehealth Physical Therapy
Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Intermountain Health Care	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Intermountain Health Care, Inc., Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Satisfaction with Telehealth Treatment	Survey of participants evaluating treatment satisfaction	10-weeks
Primary	Rate of refusal to participate	Ratio of persons entering the study among all those eligibility for enrollment	Baseline
Primary	Rate of enrolled participants initiating telehealth treatment	Ratio of persons attending at least 1 treatment session among all those enrolled	10-weeks
Primary	Number of sessions	Number of telehealth physical therapy sessions attended	10-weeks
Primary	Change in Oswestry from baseline to 10-weeks	10 item measure of back pain-related disability	baseline, 10 weeks
Primary	Change in Oswestry from baseline to 26-weeks	10 item measure of back pain-related disability	baseline, 26 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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