Chronic Low Back PainTeleBACKNCT06821607
Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)
A study testing In-Clinic Physical Therapy and Telehealth Physical Therapy (Telerehabilitation) in people with Chronic Low Back Pain, run by Johns Hopkins University at 3 sites in United States.
Trial summary
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- In-Clinic Physical Therapy and Telehealth Physical Therapy (Telerehabilitation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2025to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis.
- At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
- Meets NIH Task Force2 definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem? and 2) How often has LBP been an ongoing problem 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.
- Can speak and understand English or Spanish (Utah sites only).
Who cannot join
- Recent history (last 6 months) of lumbar spine surgery.
- Possible non-musculoskeletal cause for low back pain symptoms (e.g., pregnancy).
- Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
- Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder.
- Knowingly pregnant
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Richard L Skolasky, Sc.D., 410-502-7975, rskolas1@jhmi.edu
Richard L Skolasky, Sc.D.
- Recruiting
Intermountain Healthcare
Salt Lake City, Utah, 84111
Kate Minick, P.T., D.P.T., Ph.D., Kate.minick@imail.org
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Julie M Fritz, Ph.D., P.T., ATC, Julie.fritz@utah.edu
About this study
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization.
The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.
Read the detailed description
Low back pain (LBP) is a nearly universal human experience with 80% of adults having at least one episode in the adult's lifetime and 25% of adults reporting LBP lasting at least 1 day in the past 3 months. Not only is LBP exceedingly common, but it can be very burdensome. The tremendous burden imposed by LBP on health and well-being was recently highlighted in the Global Burden of Disease initiative of the World Health Organization, showing that LBP is associated with greater disability and overall burden for affected individuals than depression, Alzheimer's disease, substance abuse disorders, or arthritis. This high ranking of LBP reflects the sheer number of people who experience the condition and the amount of pain, functional loss, and overall diminishment in quality of life that these individuals experience. It is not surprising that LBP imposes a substantial societal burden being the most common condition encountered in healthcare and the 3rd costliest medical condition, behind only diabetes and heart disease. Despite intensive and expensive treatment efforts, the number of individuals impacted by chronic LBP continues to increase. Ineffective LBP management by health care systems is also contributing to the crisis of opioid over-prescribing.
Physical therapy (PT) has been found to be effective in reducing pain and disability related to LBP and as such, is recommended as the first line of treatment for LBP in clinical practice guidelines. Studies have shown that providing timely access to PT leads to significant decreases in pain and disability compared to usual care and has been associated with decreased odds of receiving advanced imaging, injection, surgery, or opioids over the next year. Despite the benefits of PT, only 7-13% of patients with LBP receive PT services. This low rate of utilization is likely related to barriers surrounding access (i.e., wait times, cost) and logistics (i.e., missed work time, transportation), which have been reported as reasons for not attending PT in previous studies. While these barriers are not unique to PT, the frequency of PT visits (1-3 times per week) and the length of PT care (6-12 weeks) exacerbate already existing barriers to attending in-person visits. Importantly, these barriers are amplified among minority groups and those living in rural areas of the country - minority individuals are 26% less likely than non-minority individuals to receive PT services for musculoskeletal pain.
The COVID-19 pandemic has facilitated the rapid emergence of remotely-delivered PT (i.e., telerehabilitation). Prior to the pandemic, outpatient PT was delivered almost exclusively in-person. However, as the pandemic began, policy changes led to major expansions in the way that PT is delivered. In early 2020, the Center for Medicare and Medicaid Services (CMS) announced temporary authorization for reimbursement of PT services delivered using real-time video visits. Shortly afterwards, the majority of commercial payors followed suit. A non-randomized clinical trial was recently conducted that found that patients with chronic spine pain experienced similar changes in pain, disability and quality of life with multidisciplinary rehabilitation delivered using real-time video visits compared to those that received in-clinic care. A prospective longitudinal study conducted by the study team found that a standardized PT protocol delivered using real-time video visits resulted in significant improvement in disability, pain intensity, pain interference, physical function and sleep disturbance among patients with chronic LBP.
The investigators will compare the effectiveness of telerehabilitation and in-clinic PT for patients with chronic LBP to demonstrated that telerehabilitation will provide non-inferior clinical effects to in-clinic PT.
The investigators propose to enroll 1,000 patients with chronic LBP who present to primary or specialty care at one of three health systems in Baltimore and Utah. Patients will be randomly assigned to receive an 8-session evidence-based PT treatment delivered via in-person or telehealth visits and will be followed for 12 months. Primary outcomes will be disability. Secondary outcomes will be pain intensity and interference, physical function, and patient engagement with treatment. Exploratory outcomes will be mental health, fatigue, social participation, and opioid and other LBP-related healthcare utilization. Moderating factors will be psychosocial risk for poor outcome and pain self-efficacy. Results will provide important information for patients, clinicians, physical therapists, and payers to make informed decisions about optimizing delivery of evidence-based physical therapy to improve quality of life in patients with chronic LBP.
- Conditions
- Chronic Low Back Pain
- Being tested
- In-Clinic Physical Therapy, Telehealth Physical Therapy (Telerehabilitation)
- Keywords
- chronic low back pain, physical therapy, telehealth, telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Clinic Physical TherapyBehavioural
Patients in this group will receive all PT sessions in-clinic with a trained physical therapist. Treatment provided for this group will be consistent with evidence-based guidelines that recommend patient education, exercise instruction, manual therapy interventions, and psychosocial interventions. Specific interventions to be provided within each of these categories: Education, Exercise, Manual Therapy, and Psychosocial interventions. Components of the intervention will be determined by the treating therapist based on patients' symptoms, examination findings, and patients' preferences and goals.
Telehealth Physical Therapy (Telerehabilitation)Behavioural
Those randomized to telerehabilitation will receive all PT care, including the initial evaluation and 7 follow-up sessions, via real-time video conferencing technology. Like the interventions provided to those receiving in-clinic PT, treatments provided in the telerehabilitation group will be consistent with evidence-based guidelines, adapted for delivery via real-time video visits. Consistent with the in-clinic group, specific interventions will be selected by the treating physical therapist based on patients' symptoms, examination findings, and preferences and goals. There will be an emphasis: Open-ended questions to allow patients to describe the participant's impairments and limitations; Review patient-reported measures of disability and pain intensity to help identify functional impairments; and Clinical examination of spinal movements and impairments in strength, flexibility, and joint mobility.
| Study group | Role | What they receive |
|---|---|---|
| In-Clinic Physical Therapy | Active comparator | Patients in this group will receive all PT sessions in-clinic with a trained physical therapist. Treatment provided for this group will be consistent with evidence-based guidelines that recommend patient education, exercise instruction, manual therapy interventions, and psychosocial interventions. Specific interventions to be provided within each of these categories: Education, Exercise, Manual Therapy, and Psychosocial interventions. Components of the intervention will be determined by the treating therapist based on patients' symptoms, examination findings, and patients' preferences and goals. Receives: Behavioral: In-Clinic Physical Therapy |
| Telehealth Physical Therapy (Telerehabilitation) | Experimental | Those randomized to telerehabilitation will receive all PT care, including the initial evaluation and 7 follow-up sessions, via real-time video conferencing technology. Like the interventions provided to those receiving in-clinic PT, treatments provided in the telerehabilitation group will be consistent with evidence-based guidelines, adapted for delivery via real-time video visits. Consistent with the in-clinic group, specific interventions will be selected by the treating physical therapist based on patients' symptoms, examination findings, and preferences and goals.
There will be an emphasis: Open-ended questions to allow patients to describe impairments and limitations; Review patient-reported measures of disability and pain intensity to help identify functional impairments; and Clinical examination of spinal movements and impairments in strength, flexibility, and joint mobility. Receives: Behavioral: Telehealth Physical Therapy (Telerehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index
LBP-related disability. The total score range is [0, 100] with higher values representing greater pain-related disability.
Measured: Change from baseline to 3 months after treatment initiation
Secondary outcomes (14)
Back Pain Numeric Rating Scale (NRS)
Scale of 0-10 with 0 indicating no pain and 10 indicating worst possible pain.
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in PROMIS Pain Interference (PI)
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Physical function. The total score range is [0, 100] with higher scores indicating better physical function.
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in PROMIS Pain Interference (PI) by Gender
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in PROMIS Pain Interference (PI) by Age Group
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in PROMIS Pain Interference (PI) by Psychosocial Risk
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Gender
Physical function. The total score range is [0, 100] with higher scores indicating better physical function.
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Age Group
Physical function. The total score range is [0, 100] with higher scores indicating better physical function.
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Psychosocial Risk
Physical function. The total score range is [0, 100] with higher scores indicating better physical function.
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Opioid Use
Self-reported and/or Electronic Health Record (EHR) documented opioid use
Measured: Change from baseline to 3 months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Gender
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Age Group
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Psychosocial Risk
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Measured: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Intermountain Health Care, Inc., Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Richard L. Skolasky, Sc.D., Principal investigator, Johns Hopkins UniversityKevin McLaughlin, D.P.T., Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821607
- Sponsor's protocol ID
- IRB00460142
- Acronym
- TeleBACK
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Research Team at the Johns Hopkins University for the proposal titled "Telerehabilitation for Patients with Chronic Low Back Pain (TeleBACK Clinical Trial) agree to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality, and data sharing plans to be developed by the Patient-Centered Outcomes Research Institute (PCORI). The following document exists to reflect best practices for data acquisition, management, stewardship, and dissemination that are consistent with the PCORI Public Access and Data Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)
- ClinicalTrials.gov ID
- NCT06821607
- Acronym / sponsor ID
- TeleBACK / IRB00460142
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, physical therapy, telehealth, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Utah, Intermountain Health Care, Inc., Patient-Centered Outcomes Research Institute
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 12 Feb 2025 (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.
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization.
The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.
Detailed description
Low back pain (LBP) is a nearly universal human experience with 80% of adults having at least one episode in the adult's lifetime and 25% of adults reporting LBP lasting at least 1 day in the past 3 months. Not only is LBP exceedingly common, but it can be very burdensome. The tremendous burden imposed by LBP on health and well-being was recently highlighted in the Global Burden of Disease initiative of the World Health Organization, showing that LBP is associated with greater disability and overall burden for affected individuals than depression, Alzheimer's disease, substance abuse disorders, or arthritis. This high ranking of LBP reflects the sheer number of people who experience the condition and the amount of pain, functional loss, and overall diminishment in quality of life that these individuals experience. It is not surprising that LBP imposes a substantial societal burden being the most common condition encountered in healthcare and the 3rd costliest medical condition, behind only diabetes and heart disease. Despite intensive and expensive treatment efforts, the number of individuals impacted by chronic LBP continues to increase. Ineffective LBP management by health care systems is also contributing to the crisis of opioid over-prescribing.
Physical therapy (PT) has been found to be effective in reducing pain and disability related to LBP and as such, is recommended as the first line of treatment for LBP in clinical practice guidelines. Studies have shown that providing timely access to PT leads to significant decreases in pain and disability compared to usual care and has been associated with decreased odds of receiving advanced imaging, injection, surgery, or opioids over the next year. Despite the benefits of PT, only 7-13% of patients with LBP receive PT services. This low rate of utilization is likely related to barriers surrounding access (i.e., wait times, cost) and logistics (i.e., missed work time, transportation), which have been reported as reasons for not attending PT in previous studies. While these barriers are not unique to PT, the frequency of PT visits (1-3 times per week) and the length of PT care (6-12 weeks) exacerbate already existing barriers to attending in-person visits. Importantly, these barriers are amplified among minority groups and those living in rural areas of the country - minority individuals are 26% less likely than non-minority individuals to receive PT services for musculoskeletal pain.
The COVID-19 pandemic has facilitated the rapid emergence of remotely-delivered PT (i.e., telerehabilitation). Prior to the pandemic, outpatient PT was delivered almost exclusively in-person. However, as the pandemic began, policy changes led to major expansions in the way that PT is delivered. In early 2020, the Center for Medicare and Medicaid Services (CMS) announced temporary authorization for reimbursement of PT services delivered using real-time video visits. Shortly afterwards, the majority of commercial payors followed suit. A non-randomized clinical trial was recently conducted that found that patients with chronic spine pain experienced similar changes in pain, disability and quality of life with multidisciplinary rehabilitation delivered using real-time video visits compared to those that received in-clinic care. A prospective longitudinal study conducted by the study team found that a standardized PT protocol delivered using real-time video visits resulted in significant improvement in disability, pain intensity, pain interference, physical function and sleep disturbance among patients with chronic LBP.
The investigators will compare the effectiveness of telerehabilitation and in-clinic PT for patients with chronic LBP to demonstrated that telerehabilitation will provide non-inferior clinical effects to in-clinic PT.
The investigators propose to enroll 1,000 patients with chronic LBP who present to primary or specialty care at one of three health systems in Baltimore and Utah. Patients will be randomly assigned to receive an 8-session evidence-based PT treatment delivered via in-person or telehealth visits and will be followed for 12 months. Primary outcomes will be disability. Secondary outcomes will be pain intensity and interference, physical function, and patient engagement with treatment. Exploratory outcomes will be mental health, fatigue, social participation, and opioid and other LBP-related healthcare utilization. Moderating factors will be psychosocial risk for poor outcome and pain self-efficacy. Results will provide important information for patients, clinicians, physical therapists, and payers to make informed decisions about optimizing delivery of evidence-based physical therapy to improve quality of life in patients with chronic LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Clinic Physical Therapy | Active comparator | Behavioral: In-Clinic Physical TherapyPatients in this group will receive all PT sessions in-clinic with a trained physical therapist. Treatment provided for this group will be consistent with evidence-based guidelines that recommend patient education, exercise instruction, manual therapy interventions, and psychosocial interventions. Specific interventions to be provided within each of these categories: Education, Exercise, Manual Therapy, and Psychosocial interventions. Components of the intervention will be determined by the treating therapist based on patients' symptoms, examination findings, and patients' preferences and goals. |
| Telehealth Physical Therapy (Telerehabilitation) | Experimental | Behavioral: Telehealth Physical Therapy (Telerehabilitation)Those randomized to telerehabilitation will receive all PT care, including the initial evaluation and 7 follow-up sessions, via real-time video conferencing technology. Like the interventions provided to those receiving in-clinic PT, treatments provided in the telerehabilitation group will be consistent with evidence-based guidelines, adapted for delivery via real-time video visits. Consistent with the in-clinic group, specific interventions will be selected by the treating physical therapist based on patients' symptoms, examination findings, and preferences and goals. There will be an emphasis: Open-ended questions to allow patients to describe impairments and limitations; Review patient-reported measures of disability and pain intensity to help identify functional impairments; and Clinical examination of spinal movements and impairments in strength, flexibility, and joint mobility. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis.
- At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
- Meets NIH Task Force2 definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem? and 2) How often has LBP been an ongoing problem 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.
- Can speak and understand English or Spanish (Utah sites only).
Key exclusion criteria (5 listed)
- Recent history (last 6 months) of lumbar spine surgery.
- Possible non-musculoskeletal cause for low back pain symptoms (e.g., pregnancy).
- Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
- Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder.
- Knowingly pregnant
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 |
|---|---|---|
| In-Clinic Physical TherapyPatients in this group will receive all PT sessions in-clinic with a trained physical therapist. Treatment provided for this group will be consistent with evidence-based guidelines that recommend patient education, exercise instruction, manual therapy interventions, and psychosocial interventions. Specific interventions to be provided within each of these categories: Education, Exercise, Manual Therapy, and Psychosocial interventions. Components of the intervention will be determined by the treating therapist based on patients' symptoms, examination findings, and patients' preferences and goals. | Behavioural | In-Clinic Physical Therapy |
| Telehealth Physical Therapy (Telerehabilitation)Those randomized to telerehabilitation will receive all PT care, including the initial evaluation and 7 follow-up sessions, via real-time video conferencing technology. Like the interventions provided to those receiving in-clinic PT, treatments provided in the telerehabilitation group will be consistent with evidence-based guidelines, adapted for delivery via real-time video visits. Consistent with the in-clinic group, specific interventions will be selected by the treating physical therapist based on patients' symptoms, examination findings, and preferences and goals. There will be an emphasis: Open-ended questions to allow patients to describe the participant's impairments and limitations; Review patient-reported measures of disability and pain intensity to help identify functional impairments; and Clinical examination of spinal movements and impairments in strength, flexibility, and joint mobility. | Behavioural | Telehealth Physical Therapy (Telerehabilitation) |
Primary outcome
Change in Oswestry Disability Index
Time frame: Change from baseline to 3 months after treatment initiation
LBP-related disability. The total score range is [0, 100] with higher values representing greater pain-related disability.
14 secondary outcomes
Back Pain Numeric Rating Scale (NRS)
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in PROMIS Pain Interference (PI)
Time frame: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in PROMIS Pain Interference (PI) by Gender
Time frame: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in PROMIS Pain Interference (PI) by Age Group
Time frame: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in PROMIS Pain Interference (PI) by Psychosocial Risk
Time frame: Change from baseline to 3-, 6-, and 12-months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Gender
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Age Group
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Psychosocial Risk
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Opioid Use
Time frame: Change from baseline to 3 months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Gender
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Age Group
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Psychosocial Risk
Time frame: Change from baseline to 3-, 6-, and 12- months after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. The Research Team at the Johns Hopkins University for the proposal titled "Telerehabilitation for Patients with Chronic Low Back Pain (TeleBACK Clinical Trial) agree to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality, and data sharing plans to be developed by the Patient-Centered Outcomes Research Institute (PCORI). The following document exists to reflect best practices for data acquisition, management, stewardship, and dissemination that are consistent with the PCORI Public Access and Data Sharing Policy.
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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.
Richard L. Skolasky, Sc.D. principal investigator
Johns Hopkins University
Kevin McLaughlin, D.P.T. principal investigator
Johns Hopkins School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Clinic Physical Therapy and Telehealth Physical Therapy (Telerehabilitation) in people with Chronic Low Back Pain, run by Johns Hopkins University at 3 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 5 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard L Skolasky, Sc.D. (410-502-7975, rskolas1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (time frame: Change from baseline to 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.