Low Back PainTeleOPTNCT05103462
Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713
A study testing Telehealth Physical Therapy in people with Low Back Pain, run by University of Utah at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Telehealth Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2020to 13 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Intermountain Health Care
Salt Lake City, Utah, 84107
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Telehealth Physical Therapy
- Keywords
- Telehealth, Physical therapy, Chronic pain
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Physical TherapyBehavioural
Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telehealth Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction with Telehealth Treatment
Survey of participants evaluating treatment satisfaction
Measured: 10-weeks
Rate of refusal to participate
Ratio of persons entering the study among all those eligibility for enrollment
Measured: Baseline
Rate of enrolled participants initiating telehealth treatment
Ratio of persons attending at least 1 treatment session among all those enrolled
Measured: 10-weeks
Number of sessions
Number of telehealth physical therapy sessions attended
Measured: 10-weeks
Change in Oswestry from baseline to 10-weeks
10 item measure of back pain-related disability
Measured: baseline, 10 weeks
Change in Oswestry from baseline to 26-weeks
10 item measure of back pain-related disability
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start18 Aug 2020
- Primary completion18 Dec 2020
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, longitudinal cohort design
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc., Johns Hopkins University
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
- Investigators
- Julie Fritz, PT, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103462
- Sponsor's protocol ID
- IRB_00116150
- Acronym
- TeleOPT
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32393216McLaughlin KH, Fritz JM, Minick KI, Brennan GP, McGee T, Lane E, Thackeray A, Bardsley T, Wegener ST, Hunter SJ, Skolasky RL. Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain. Phys Ther. 2024 Mar 1;104(3):pzad180. doi: 10.1093/ptj/pzad180.
PubMed 38157307Fritz 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.
PubMed 35667399
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05103462
- Acronym / sponsor ID
- TeleOPT / IRB_00116150
- Conditions
- Low Back Pain
- Keywords
- Telehealth, Physical therapy, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc., Johns Hopkins University
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, longitudinal cohort design
| Arm | Type | Receives |
|---|---|---|
| Telehealth Physical Therapy | Experimental | Behavioral: Telehealth Physical TherapyWeekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Physical TherapyWeekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction. | Behavioural | Telehealth Physical Therapy |
Primary outcome
Participant Satisfaction with Telehealth Treatment
Time frame: 10-weeks
Survey of participants evaluating treatment satisfaction
Rate of refusal to participate
Time frame: Baseline
Ratio of persons entering the study among all those eligibility for enrollment
Rate of enrolled participants initiating telehealth treatment
Time frame: 10-weeks
Ratio of persons attending at least 1 treatment session among all those enrolled
Number of sessions
Time frame: 10-weeks
Number of telehealth physical therapy sessions attended
Change in Oswestry from baseline to 10-weeks
Time frame: baseline, 10 weeks
10 item measure of back pain-related disability
Change in Oswestry from baseline to 26-weeks
Time frame: baseline, 26 weeks
10 item measure of back pain-related disability
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Background: PubMed 32393216Skolasky 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.
- Derived from this study: PubMed 38157307McLaughlin KH, Fritz JM, Minick KI, Brennan GP, McGee T, Lane E, Thackeray A, Bardsley T, Wegener ST, Hunter SJ, Skolasky RL. Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain. Phys Ther. 2024 Mar 1;104(3):pzad180. doi: 10.1093/ptj/pzad180.
- Derived from this study: PubMed 35667399Fritz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Fritz, PT, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Physical Therapy in people with Low Back Pain, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction with Telehealth Treatment (time frame: 10-weeks). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103462, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.