Back PainPhase 3NCT00769626
Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
A Phase 3 study testing Early Treatment in people with Back Pain and Low Back Pain, run by Intermountain Health Care, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to compare the clinical outcomes and costs associated with two different management strategies for patients with acute low back pain who consult their primary care physician. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Back Pain, Low Back Pain
- What is being tested?
- Early Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, originate from the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Both of the clinical decision rule criteria: Duration of current symptoms < 16 days, and patient report of no symptoms (pain, numbness, etc.) distal to the knee since onset.
Who cannot join
- Prior surgery to the lumbosacral spine
- Current pregnancy
- Neurogenic LBP defined as the presence of either: a positive straight leg raise test (symptom reproduction at <450) or reflex, sensory, or strength consistent with lumbar nerve root compression
- Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, or infection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Intermountain Healthcare, South Jordan Health Center
South Jordan, Utah, 84095
Intermountain Healthcare Taylorsville Health Center
Taylorsville, Utah, 84118
Intermountain Healthcare West Jordan Health Center
West Jordan, Utah, 84088
About this study
Official title: Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy: A Randomized Clinical Trial
The purpose of this study is to compare the clinical outcomes and costs associated with two different management strategies for patients with acute low back pain who consult their primary care physician. The investigators hypothesize that management using a brief, standardized physical therapy intervention will result in better outcomes than management based on current practice guideline recommendations of watchful waiting for the first 4 weeks following consultation.
Read the detailed description
The Institute of Medicine recognizes low back pain (LBP) as a top 15 priority condition, calling for health care organizations to develop new, evidence-based management strategies. Most patients with acute LBP are managed in primary care. Primary care management is characterized by high variability in decision-making, including referral to specialties such as physical therapy. In the face of this variability it is not surprising that the outcomes of management for patients with acute LBP are also inconsistent, with a considerable proportion going on to persistent or recurrent symptoms. Costs associated with patients who fail to recover quickly or completely can be substantial.
Many patients with acute LBP are referred from primary care to physical therapy. Physical therapy management of patients with acute LBP is also highly variable in terms of the interventions used and the outcomes achieved. More effective and standardized management for patients with acute LBP could impact progression of the condition before the concerns associated with chronic pain become evident, and are therefore central to reducing costs and improving outcomes.
Numerous practice guidelines have been developed to attempt to reduce variability and improve outcomes for patients with acute LBP managed in primary care. Current guidelines provide little direction for determining the optimal type of patient and timing for referral to physical therapy, other than a broad recommendation to delay referral for at least a few weeks. Within physical therapy there is an absence of validated decision-support tools to reduce inappropriate variation in care and improve outcomes. The Investigators have developed and validated a clinical decision rule identifying a subgroup of patients with LBP likely to experience rapid and sustained improvement with a brief, standardized physical therapy intervention delivered early in the course of care, suggesting it may be more cost-effective to manage this subgroup with early referral to physical therapy. The impact of integrating this rule into routine clinical care has not been assessed.
We will conduct a randomized clinical trial examining outcomes and costs associated with integrating the decision rule into primary care management of patients with LBP. Patients with LBP who fit the decision rule criteria will be randomized into one of two groups; one managed with usual care based on current practice guidelines; the other managed based on the decision rule with early, standardized physical therapy. Patients will be followed for 6 months. Outcomes will include measures of disability, pain, satisfaction, and costs.
- Conditions
- Back Pain, Low Back Pain
- Being tested
- Usual Care, Early Treatment
- Keywords
- Low Back Pain, Clinical Practice Guidelines, Spinal Manipulation, Physical Therapy Techniques
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Patients in the usual care group will receive advice and education to remain active and anticipate a favorable prognosis. Patients will also receive medication from the primary care provider consistent with current evidence-based guidelines(acetaminophen or non-steroidal anti-inflammatories). Consistent with current practice guidelines, patients will be instructed to return to the primary care provider if they are not satisfied with their progress after 4 weeks.
Early TreatmentOther
Patients in the early treatment group will receive the usual care intervention (advice and education, and medication consistent with current evidence-based guidelines). Patients will also be referred to physical therapy for 4 sessions over a 3-week period. A standardized protocol will be used in physical therapy including spinal manipulation and trunk strengthening exercises. Patients will be instructed to return to the primary care provider if they are not satisfied with their progress after completion of the 4 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment | Experimental | Not described Receives: Other: Early Treatment |
| Usual Care | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Questionnaire Patient Global Rating of Improvement
Measured: 6 months
Secondary outcomes (1)
Numeric Pain Rating Scale Fear-Avoidance Beliefs Questionnaire Patient Satisfaction Questionnaire European Quality of Life (EuroQOL) Direct medical costs
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 posted9 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionMay 2010
Why it stopped: Unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Julie M Fritz, PhD,PT,ATC, Principal investigator, Intermountain Healthcare, The University of UtahGerard P Brennan, PhD, PT, Study director, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769626
- Sponsor's protocol ID
- DES-529-2008
- Status last verified
- Oct 2008
- First submitted
- 8 Oct 2008
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00769626
- Acronym / sponsor ID
- DES-529-2008
- Conditions
- Back Pain, Low Back Pain
- Keywords
- Low Back Pain, Clinical Practice Guidelines, Spinal Manipulation, Physical Therapy Techniques
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Oct 2008 (estimated)
- 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 purpose of this study is to compare the clinical outcomes and costs associated with two different management strategies for patients with acute low back pain who consult their primary care physician. The investigators hypothesize that management using a brief, standardized physical therapy intervention will result in better outcomes than management based on current practice guideline recommendations of watchful waiting for the first 4 weeks following consultation.
Detailed description
The Institute of Medicine recognizes low back pain (LBP) as a top 15 priority condition, calling for health care organizations to develop new, evidence-based management strategies. Most patients with acute LBP are managed in primary care. Primary care management is characterized by high variability in decision-making, including referral to specialties such as physical therapy. In the face of this variability it is not surprising that the outcomes of management for patients with acute LBP are also inconsistent, with a considerable proportion going on to persistent or recurrent symptoms. Costs associated with patients who fail to recover quickly or completely can be substantial.
Many patients with acute LBP are referred from primary care to physical therapy. Physical therapy management of patients with acute LBP is also highly variable in terms of the interventions used and the outcomes achieved. More effective and standardized management for patients with acute LBP could impact progression of the condition before the concerns associated with chronic pain become evident, and are therefore central to reducing costs and improving outcomes.
Numerous practice guidelines have been developed to attempt to reduce variability and improve outcomes for patients with acute LBP managed in primary care. Current guidelines provide little direction for determining the optimal type of patient and timing for referral to physical therapy, other than a broad recommendation to delay referral for at least a few weeks. Within physical therapy there is an absence of validated decision-support tools to reduce inappropriate variation in care and improve outcomes. The Investigators have developed and validated a clinical decision rule identifying a subgroup of patients with LBP likely to experience rapid and sustained improvement with a brief, standardized physical therapy intervention delivered early in the course of care, suggesting it may be more cost-effective to manage this subgroup with early referral to physical therapy. The impact of integrating this rule into routine clinical care has not been assessed.
We will conduct a randomized clinical trial examining outcomes and costs associated with integrating the decision rule into primary care management of patients with LBP. Patients with LBP who fit the decision rule criteria will be randomized into one of two groups; one managed with usual care based on current practice guidelines; the other managed based on the decision rule with early, standardized physical therapy. Patients will be followed for 6 months. Outcomes will include measures of disability, pain, satisfaction, and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Treatment | Experimental | Other: Early Treatment |
| Usual Care | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, originate from the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Both of the clinical decision rule criteria: Duration of current symptoms < 16 days, and patient report of no symptoms (pain, numbness, etc.) distal to the knee since onset.
Key exclusion criteria (4 listed)
- Prior surgery to the lumbosacral spine
- Current pregnancy
- Neurogenic LBP defined as the presence of either: a positive straight leg raise test (symptom reproduction at <450) or reflex, sensory, or strength consistent with lumbar nerve root compression
- Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, or infection
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 |
|---|---|---|
| Usual CarePatients in the usual care group will receive advice and education to remain active and anticipate a favorable prognosis. Patients will also receive medication from the primary care provider consistent with current evidence-based guidelines(acetaminophen or non-steroidal anti-inflammatories). Consistent with current practice guidelines, patients will be instructed to return to the primary care provider if they are not satisfied with their progress after 4 weeks. | Other | Usual Care |
| Early TreatmentPatients in the early treatment group will receive the usual care intervention (advice and education, and medication consistent with current evidence-based guidelines). Patients will also be referred to physical therapy for 4 sessions over a 3-week period. A standardized protocol will be used in physical therapy including spinal manipulation and trunk strengthening exercises. Patients will be instructed to return to the primary care provider if they are not satisfied with their progress after completion of the 4 sessions. | Other | Early Treatment |
Primary outcome
Oswestry Disability Questionnaire Patient Global Rating of Improvement
Time frame: 6 months
1 secondary outcome
Numeric Pain Rating Scale Fear-Avoidance Beliefs Questionnaire Patient Satisfaction Questionnaire European Quality of Life (EuroQOL) Direct medical costs
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Unable to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
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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 M Fritz, PhD,PT,ATC principal investigator
Intermountain Healthcare, The University of Utah
Gerard P Brennan, PhD, PT study director
Intermountain Health Care, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early Treatment in people with Back Pain and Low Back Pain, run by Intermountain Health Care, Inc. 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 4 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 18 Jul 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit patients). 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?
Oswestry Disability Questionnaire Patient Global Rating of Improvement (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 18 Jul 2011.