Chronic Low-back PainARBOR-ThNCT06471920
Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Telerehabilitation
A study testing Standardized Education and Telerehabilitation in people with Chronic Low-back Pain, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Standardized Education and Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to 31 Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care visit in the past 90 days with an LBP-related International Classification of Diseases (ICD-10) diagnosis.
- Age 18 years or older.
- At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
- Meets NIH Task Force 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.
- Access to video-enabled device and Internet.
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Richard L Skolasky, ScD, 410-502-7975, rskolas1@jhmi.edu
Richard L Skolasky, ScD
- Recruiting
Tidalhealth
Salisbury, Maryland, 21801
Jill Stone, PT, 410-543-7017, jill.stone@tidalhealth.org
Robert Joyner, Ph.D., 410-543-7017, Robert.joyner@tidalhealth.org
About this study
Official title: ARBOR Telehealth: Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Improved Access to Telerehabilitation
Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-informed telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.
Read the detailed description
Chronic low back pain (LBP) imposes tremendous burden on affected individuals, healthcare systems, and society. LBP has been identified as the most common cause of disability globally and in the United States (US). LBP is also the largest driver of US healthcare spending ($135 billion in 2016) and the most common diagnoses associated with opioid prescription and consumption. For patients with chronic LBP, physical therapy has been shown to be a cost-effective method for improving pain and disability. In addition, physical therapy has been shown to decrease the risk of advanced imaging, injections, surgery, and opioid use in patients with chronic LBP.
Despite available evidence in support, only 7-13% of patients with LBP, including those with chronic LBP, go on to receive physical therapy services, with patients reporting barriers accessing physical therapy, such as transportation, provider availability and missed work time. Access is especially limited in rural communities where there are approximately 40% fewer physical therapists available per capita compared to metropolitan regions. In addition, patients living in rural communities likely need to travel longer distances to receive physical therapy, requiring additional missed work time and transportation costs. This lack of access to physical therapy in rural communities likely contributes to the greater rates of LBP-related disability and opioid consumption that have been observed in rural communities compared to metropolitan areas. Innovative methods for improving access to physical therapy are urgently needed to address disparities in outcomes for patients with chronic LBP living in rural communities in the US. Telehealth has rapidly expanded during the COVID-19 pandemic. This includes policy changes that have allowed physical therapists to begin providing care remotely, also referred to as telerehabilitation. Telerehabilitation stands to improve access to physical therapy for patients with chronic LBP living in rural communities and may serve as a means of improving outcomes of these patients.
The investigators will conduct a prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-informed telerehabilitation to reduce opioid use and LBP-related disability and to improve physical function and health-related quality of life (HRQoL) in patients with chronic LBP. Additionally, 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 434 patients with LBP presenting to primary care clinics serving rural communities (TidalHealth, Salisbury, MD). Eligible patients will provide informed consent and be randomized to either web-based standardized education or risk-informed telerehabilitation (physical therapy telehealth visits, or informed physical therapy telehealth visits). Primary effectiveness outcome is difference in change in LBP-related disability (Oswestry Disability Index) and in opioid use after 8 weeks of treatment.
- Conditions
- Chronic Low-back Pain
- Being tested
- Standardized Education, Telerehabilitation
- Keywords
- chronic low back pain, physical therapy, Telehealth, telerehabilitation, rural, opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized EducationBehavioural
Patients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest.
TelerehabilitationBehavioural
Based on prior SBTS risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to PIPT telehealth visits (high-risk).
| Study group | Role | What they receive |
|---|---|---|
| Standardized Education | Active comparator | Patients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest. To promote increased physical activity levels, the website will also include pictures and videos of common exercises targeting the lumbopelvic region that patients can perform independently without the need for exercise equipment. Receives: Behavioral: Standardized Education |
| Telerehabilitation | Experimental | Based on prior STarT Back Tool (SBTS) screening risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to psychological informed physical therapy (PIPT) telehealth visits (high-risk).
The SBTS is a short questionnaire that assesses an individual's physical, psychosocial, and psychological risk factors for chronic back pain that can be improved with treatment. Receives: Behavioral: 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 12 weeks after treatment initiation
Participants with Opioid Use
self-reported and/or Electronic Health Record (EHR) documented opioid use
Measured: Post treatment initiation 12 weeks
Secondary outcomes (12)
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 26- and 52-weeks after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Biological Sex
Physical function. The total score range is [0, 100] with higher scores indicating better physical function.
Measured: Change from baseline to 26- and 52-weeks 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 26- and 52-weeks after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Baseline Opioid Use
Physical function. The total score range is [0, 100] with higher scores indicating better physical function.
Measured: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr)
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Biological Sex
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Age Group
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Baseline Opioid Use
Total score range is [0, 100] with higher scores indicating better outcome.
Measured: Change from baseline to 26- and 52-weeks 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: 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Biological Sex
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Measured: 26- and 52-weeks 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: 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Baseline Opioid Use
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Measured: 26- and 52-weeks 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 posted24 Jun 2024
- Study start27 Jan 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- A pragmatic randomized clinical trial used a Type I Hybrid effectiveness-implementation design
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- TidalHealth, Inc., Medstar Health Research Institute, Maryland Rural Health Association, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Richard L Skolasky, Sc.D., Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471920
- Sponsor's protocol ID
- IRB00437961
- Other IDs
- UG3AR083838
- Acronym
- ARBOR-Th
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2024
- Last updated
- 22 Jul 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 and TidalHealth (sub-award) for the proposal titled "Improving Function and Reducing Opioid Use for Patients with Chronic Low Back Pain in Rural Communities through Improved Access to Physical Therapy using Telerehabilitation" (RFA-NR-23-001) agree to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality, and data sharing plans to be developed by the Helping to End Addiction Long-term (HEAL) Consortium. The following document exists to reflect best practices for data acquisition, management, stewardship, and dissemination that are consistent with the HEAL Initiative Public Access and Data Sharing Policy.
Publications
Skolasky RL, Colantuoni E, Wegener ST, Ali KJ, McLaughlin KH. ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities - protocol of a pragmatic, individually randomised group treatment trial. BMJ Open. 2025 Jun 10;15(6):e102773. doi: 10.1136/bmjopen-2025-102773.
PubMed 40499966
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARBOR Telehealth: Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Improved Access to Telerehabilitation
- ClinicalTrials.gov ID
- NCT06471920
- Acronym / sponsor ID
- ARBOR-Th / IRB00437961
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, physical therapy, Telehealth, telerehabilitation, rural, opioid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- TidalHealth, Inc., Medstar Health Research Institute, Maryland Rural Health Association, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 24 Jun 2024 (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.
Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-informed telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.
Detailed description
Chronic low back pain (LBP) imposes tremendous burden on affected individuals, healthcare systems, and society. LBP has been identified as the most common cause of disability globally and in the United States (US). LBP is also the largest driver of US healthcare spending ($135 billion in 2016) and the most common diagnoses associated with opioid prescription and consumption. For patients with chronic LBP, physical therapy has been shown to be a cost-effective method for improving pain and disability. In addition, physical therapy has been shown to decrease the risk of advanced imaging, injections, surgery, and opioid use in patients with chronic LBP.
Despite available evidence in support, only 7-13% of patients with LBP, including those with chronic LBP, go on to receive physical therapy services, with patients reporting barriers accessing physical therapy, such as transportation, provider availability and missed work time. Access is especially limited in rural communities where there are approximately 40% fewer physical therapists available per capita compared to metropolitan regions. In addition, patients living in rural communities likely need to travel longer distances to receive physical therapy, requiring additional missed work time and transportation costs. This lack of access to physical therapy in rural communities likely contributes to the greater rates of LBP-related disability and opioid consumption that have been observed in rural communities compared to metropolitan areas. Innovative methods for improving access to physical therapy are urgently needed to address disparities in outcomes for patients with chronic LBP living in rural communities in the US. Telehealth has rapidly expanded during the COVID-19 pandemic. This includes policy changes that have allowed physical therapists to begin providing care remotely, also referred to as telerehabilitation. Telerehabilitation stands to improve access to physical therapy for patients with chronic LBP living in rural communities and may serve as a means of improving outcomes of these patients.
The investigators will conduct a prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-informed telerehabilitation to reduce opioid use and LBP-related disability and to improve physical function and health-related quality of life (HRQoL) in patients with chronic LBP. Additionally, 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 434 patients with LBP presenting to primary care clinics serving rural communities (TidalHealth, Salisbury, MD). Eligible patients will provide informed consent and be randomized to either web-based standardized education or risk-informed telerehabilitation (physical therapy telehealth visits, or informed physical therapy telehealth visits). Primary effectiveness outcome is difference in change in LBP-related disability (Oswestry Disability Index) and in opioid use after 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic randomized clinical trial used a Type I Hybrid effectiveness-implementation design
| Arm | Type | Receives |
|---|---|---|
| Standardized Education | Active comparator | Behavioral: Standardized EducationPatients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest. To promote increased physical activity levels, the website will also include pictures and videos of common exercises targeting the lumbopelvic region that patients can perform independently without the need for exercise equipment. |
| Telerehabilitation | Experimental | Behavioral: TelerehabilitationBased on prior STarT Back Tool (SBTS) screening risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to psychological informed physical therapy (PIPT) telehealth visits (high-risk). The SBTS is a short questionnaire that assesses an individual's physical, psychosocial, and psychological risk factors for chronic back pain that can be improved with treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary care visit in the past 90 days with an LBP-related International Classification of Diseases (ICD-10) diagnosis.
- Age 18 years or older.
- At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
- Meets NIH Task Force 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.
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 |
|---|---|---|
| Standardized EducationPatients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest. | Behavioural | Standardized Education |
| TelerehabilitationBased on prior SBTS risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to PIPT telehealth visits (high-risk). | Behavioural | Telerehabilitation |
Primary outcome
Change in Oswestry Disability Index
Time frame: Change from baseline to 12 weeks after treatment initiation
LBP-related disability. The total score range is [0, 100] with higher values representing greater pain-related disability.
Participants with Opioid Use
Time frame: Post treatment initiation 12 weeks
self-reported and/or Electronic Health Record (EHR) documented opioid use
12 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Biological Sex
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Age Group
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Baseline Opioid Use
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr)
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Biological Sex
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Age Group
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Baseline Opioid Use
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use
Time frame: 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Biological Sex
Time frame: 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Age Group
Time frame: 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Baseline Opioid Use
Time frame: 26- and 52-weeks 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 22 Jul 2026.
- Derived from this study: PubMed 40499966Skolasky RL, Colantuoni E, Wegener ST, Ali KJ, McLaughlin KH. ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities - protocol of a pragmatic, individually randomised group treatment trial. BMJ Open. 2025 Jun 10;15(6):e102773. doi: 10.1136/bmjopen-2025-102773.
- Individual participant dataSharing planned: Yes. The Research Team at the Johns Hopkins University and TidalHealth (sub-award) for the proposal titled "Improving Function and Reducing Opioid Use for Patients with Chronic Low Back Pain in Rural Communities through Improved Access to Physical Therapy using Telerehabilitation" (RFA-NR-23-001) agree to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality, and data sharing plans to be developed by the Helping to End Addiction Long-term (HEAL) Consortium. The following document exists to reflect best practices for data acquisition, management, stewardship, and dissemination that are consistent with the HEAL Initiative 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 School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Education and Telerehabilitation in people with Chronic Low-back Pain, run by Johns Hopkins University 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 6 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 22 Jul 2026. 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?
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 12 weeks after treatment initiation). The study lists 2 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 NCT06471920, which also lists 1 linked publication.
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 22 Jul 2026.