Low Back PainNCT03065894
Risk Stratification in Primary Care Combined With Stratified-specific Physical Therapy Care for Low Back Pain
A study testing Matched Physical Therapy Intervention and Current Care in Family Medicine in people with Low Back Pain, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
This study aims to examine patient outcomes following risk stratification for low back pain in Family Medicine combined with either matched physical therapy (PT - i.e., stratified-specific PT) treatments or current treatment in primary care across The University of Vermont Health Network. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Matched Physical Therapy Intervention and Current Care in Family Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 31 Aug 2018
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of acute, chronic or non-specific LBP,
- between 21 - 60 years of age,
- able to stand and walk without assistance,
- able to understand and read English,
- able to understand and sign a consent form.
Who cannot join
- active serious spinal complications such as tumor or infection,
- active treatment for metastatic or bone cancer of the spine,
- pregnancy or less than 6 months post-partum or less than 6 months post weaning.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Does Risk Stratification in Primary Care Combined With Stratified-specific Physical Therapy Care Improve Clinical Outcomes for Patients With Nonspecific Low Back Pain Compared to Those Who Receive Only Current Care?
This study aims to examine patient outcomes following risk stratification for low back pain in Family Medicine combined with either matched physical therapy (PT - i.e., stratified-specific PT) treatments or current treatment in primary care across The University of Vermont Health Network.
Read the detailed description
The University of Vermont Health Network is a five hospital network that serves primarily a rural population of approximately 1 million people in Vermont and upstate New York. The primary aim of this prospective, longitudinal, pragmatic, non-randomized clustered, non-blinded, controlled trial is to examine whether PT treatment stratified to match the patient's risk factors based on the STarT Back Tool is more effective than the current treatment in primary care for non-specific low back pain (LBP) in improving short- (6 months) and long-term (12-month) patient outcomes (disability).
To do the risk stratification, investigators will use the STarT Back Tool which is designed for primary care settings and is validated for non-specific LBP (acute flare-ups or chronic pain). The tool is designed to identify the prognostic risk (low, medium, high) for progression to chronic LBP. In addition, the tool assists clinicians in decision making to ensure that low risk patients are not over treated or medicalized, that 'at risk' patients get access to the right provider early on and that enhanced care is given for complex cases. Thus, the tool assists in matching the 'right patient to the right treatment' at the 'right time' which is critical given the high prevalence and cost of LBP.
Patients with a primary diagnosis of LBP (acute flare-up or chronic) who are seen in any of the six Family Medicine sites will complete the STarT Back Tool and the Modified Low Back Pain Disability Questionnaire (mODI). With the non-randomized, cluster design, three of the Family Medicine sites are identified as "Participating Sites" and three are identified as "Comparator Sites." Patients with low back pain from "Participating Sites" who are stratified as medium- or high-risk patients will be referred to physical therapy (PT) for a matched (i.e., stratified-specific treatment). Those patients who are identified as low-risk will be retained in Family Medicine for management using advice, reassurance, patient education, NSAIDs (no imaging or specialist referral is encouraged). Patients with low back pain from "Comparator Sites" will be managed according to current care practices in Family Medicine. Using the mODI, the investigators will compare the two study arms at short- (6 months) and long-term points (12 months).
- Conditions
- Low Back Pain
- Being tested
- Matched Physical Therapy Intervention, Current Care in Family Medicine
- Keywords
- stratified care, psychologically informed practice, matched care
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matched Physical Therapy InterventionOther
Patients who are medium-risk will receive up to 6-8 physical therapy (PT) visits over a 3 month period that is guided by published evidence based practice guidelines. The PT treatment will be tailored to the physical findings and specific patient needs, and appropriate exercises, spinal mobilization/manipulation, strengthening/stretching as well as a home program will be given to improve patient pain and function and reduce disability.
Patients who are high-risk will receive the evidence based PT treatment as deemed necessary. In addition, the PT treatment will incorporate principles of psychologically informed practice to address psychosocial barriers (e.g., fear avoidance, anxiety, etc) that may be impeding disability reduction. This may include instruction on chronic pain rehabilitation techniques such as the use of: pacing in order to maintain or increase activity; graded activity principles in order to increase function; and pain education and understanding responses to pain.
Current Care in Family MedicineOther
Patient education, medication management
| Study group | Role | What they receive |
|---|---|---|
| Stratified Care | Experimental | In three "Participating Sites" from Family Medicine sites, the Keele STarT Back Screening Tool will be administered to patients with acute and chronic low back pain and based on patients' responses, patients will be stratified into one of three risk groups: low, medium or high-risk. Patients in the medium- and high-risk groups will be referred to physical therapy for a matched physical therapy (PT) intervention based on the risk strata. Patients in the low-risk group will be managed in Family Medicine with an intervention that includes advice, reassurance, patient education, and NSAIDs (with no referral for imaging or specialist care). Receives: Other: Matched Physical Therapy Intervention |
| Current Care | Active comparator | In three "Comparator Sites" from Family Medicine, providers will give the current care at The University of Vermont Medical Center for patients with acute and chronic low back pain. Receives: Other: Current Care in Family Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Low Back Pain Disability Questionnaire
Low back pain disability measure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start29 Mar 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Why it stopped: Lack of subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, longitudinal, pragmatic, non-randomized clustered, non-blinded, controlled trial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Henry, University of Vermont Medical Center
- Investigators
- Sharon M Henry, PT, PhD, Principal investigator, The University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065894
- Sponsor's protocol ID
- 16-494
- Status last verified
- Sep 2018
- First submitted
- 23 Feb 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Risk Stratification in Primary Care Combined With Stratified-specific Physical Therapy Care Improve Clinical Outcomes for Patients With Nonspecific Low Back Pain Compared to Those Who Receive Only Current Care?
- ClinicalTrials.gov ID
- NCT03065894
- Acronym / sponsor ID
- 16-494
- Conditions
- Low Back Pain
- Keywords
- stratified care, psychologically informed practice, matched care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject enrollment
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 28 Feb 2017 (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 aims to examine patient outcomes following risk stratification for low back pain in Family Medicine combined with either matched physical therapy (PT - i.e., stratified-specific PT) treatments or current treatment in primary care across The University of Vermont Health Network.
Detailed description
The University of Vermont Health Network is a five hospital network that serves primarily a rural population of approximately 1 million people in Vermont and upstate New York. The primary aim of this prospective, longitudinal, pragmatic, non-randomized clustered, non-blinded, controlled trial is to examine whether PT treatment stratified to match the patient's risk factors based on the STarT Back Tool is more effective than the current treatment in primary care for non-specific low back pain (LBP) in improving short- (6 months) and long-term (12-month) patient outcomes (disability).
To do the risk stratification, investigators will use the STarT Back Tool which is designed for primary care settings and is validated for non-specific LBP (acute flare-ups or chronic pain). The tool is designed to identify the prognostic risk (low, medium, high) for progression to chronic LBP. In addition, the tool assists clinicians in decision making to ensure that low risk patients are not over treated or medicalized, that 'at risk' patients get access to the right provider early on and that enhanced care is given for complex cases. Thus, the tool assists in matching the 'right patient to the right treatment' at the 'right time' which is critical given the high prevalence and cost of LBP.
Patients with a primary diagnosis of LBP (acute flare-up or chronic) who are seen in any of the six Family Medicine sites will complete the STarT Back Tool and the Modified Low Back Pain Disability Questionnaire (mODI). With the non-randomized, cluster design, three of the Family Medicine sites are identified as "Participating Sites" and three are identified as "Comparator Sites." Patients with low back pain from "Participating Sites" who are stratified as medium- or high-risk patients will be referred to physical therapy (PT) for a matched (i.e., stratified-specific treatment). Those patients who are identified as low-risk will be retained in Family Medicine for management using advice, reassurance, patient education, NSAIDs (no imaging or specialist referral is encouraged). Patients with low back pain from "Comparator Sites" will be managed according to current care practices in Family Medicine. Using the mODI, the investigators will compare the two study arms at short- (6 months) and long-term points (12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, longitudinal, pragmatic, non-randomized clustered, non-blinded, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Stratified Care | Experimental | Other: Matched Physical Therapy InterventionIn three "Participating Sites" from Family Medicine sites, the Keele STarT Back Screening Tool will be administered to patients with acute and chronic low back pain and based on patients' responses, patients will be stratified into one of three risk groups: low, medium or high-risk. Patients in the medium- and high-risk groups will be referred to physical therapy for a matched physical therapy (PT) intervention based on the risk strata. Patients in the low-risk group will be managed in Family Medicine with an intervention that includes advice, reassurance, patient education, and NSAIDs (with no referral for imaging or specialist care). |
| Current Care | Active comparator | Other: Current Care in Family MedicineIn three "Comparator Sites" from Family Medicine, providers will give the current care at The University of Vermont Medical Center for patients with acute and chronic low back pain. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of acute, chronic or non-specific LBP,
- between 21 - 60 years of age,
- able to stand and walk without assistance,
- able to understand and read English,
- able to understand and sign a consent form.
Key exclusion criteria (3 listed)
- active serious spinal complications such as tumor or infection,
- active treatment for metastatic or bone cancer of the spine,
- pregnancy or less than 6 months post-partum or less than 6 months post weaning.
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 |
|---|---|---|
| Matched Physical Therapy InterventionPatients who are medium-risk will receive up to 6-8 physical therapy (PT) visits over a 3 month period that is guided by published evidence based practice guidelines. The PT treatment will be tailored to the physical findings and specific patient needs, and appropriate exercises, spinal mobilization/manipulation, strengthening/stretching as well as a home program will be given to improve patient pain and function and reduce disability. Patients who are high-risk will receive the evidence based PT treatment as deemed necessary. In addition, the PT treatment will incorporate principles of psychologically informed practice to address psychosocial barriers (e.g., fear avoidance, anxiety, etc) that may be impeding disability reduction. This may include instruction on chronic pain rehabilitation techniques such as the use of: pacing in order to maintain or increase activity; graded activity principles in order to increase function; and pain education and understanding responses to pain. | Other | Stratified Care |
| Current Care in Family MedicinePatient education, medication management | Other | Current Care |
Primary outcome
Modified Low Back Pain Disability Questionnaire
Time frame: 6 months
Low back pain disability measure
Results and safety
The study was stopped early (reason given: Lack of subject enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
Low Back Pain, Functional Motor Disorder
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.
Sharon M Henry, PT, PhD principal investigator
The University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matched Physical Therapy Intervention and Current Care in Family Medicine in people with Low Back Pain, run by University of Vermont Medical Center at 1 site 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Lack of subject enrollment). Results are not available in the source record.
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?
Modified Low Back Pain Disability Questionnaire (time frame: 6 months). 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 7 Sep 2018.