Low Back PainNCT01726803
Comparative Effectiveness of Acute Low Back Pain Management
A study of Low Back Pain, run by University of Utah at 2 sites in United States.
Trial summary
Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, are originating from tissues of the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Both of the following clinical decision rule criteria: a)Duration of current symptoms < 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.
Who cannot join
- Prior surgery to the lumbosacral spine
- Any treatment for low back pain in past 6 months
- Current pregnancy
- Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
- Presence of neurogenic LBP defined as the presence of either of the following:
- Positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45 degrees); or b)Reflex, sensory, or strength deficits in a pattern 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, infection or systemic disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Health Care
Salt Lake City, Utah, 84106
The University of Utah Healthcare System
Salt Lake City, Utah, 84108
About this study
Official title: Comparative Effectiveness of Management Strategies for Acute Low Back Pain
Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.
- Conditions
- Low Back Pain
- Being tested
- Early Physical Therapy with Usual Care, Usual Care
- Keywords
- Low Back Pain, Primary Care, Physical Therapy
- 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.
Early Physical Therapy with Usual CareOther
The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.
Usual CareOther
The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks. Receives: Other: Usual Care |
| Early Physical Therapy with Usual Care | Experimental | The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise. Receives: Other: Early Physical Therapy with Usual Care; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability.
Measured: 3 months
Secondary outcomes (7)
Numeric Pain Rating
0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity.
Measured: 3 months
EQ-5D
European Quality of Life Measure, assesses general quality of life. Scores are expressed on a scale from 0 - 1.0 with higher scores representing greater quality of life.
Measured: 3 months
Fear-Avoidance Beliefs Questionnaire (Work Subscale)
Measures fear-avoidance beliefs related to work. Scores range from 0-42 with higher numbers representing greater levels of fear avoidance beliefs about work.
Measured: 3 months
Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)
15-point patient global rating scale. Patient is asked to rate current condition relative to condition at the beginning of treatment on a scale ranging from "A Very Great Deal Worse" to "A Very Great Deal Better". Higher numbers indicate greater self-rating. Those rating at least 12 are considered successful as a dichotomous outcome.
Measured: 3 months
Health Care Utilization (MRI)
Utilization of healthcare for low back pain (MRI utilization)
Measured: 12 months
Pain Catastrophizing
13-item Pain Catastrophizing Scale assessing the extent of catastrophizing thinking is response to pain. Each item is scored 1-4 for a total score of 13-52. Higher numbers indicate greater levels of catastrophizing.
Measured: 3 months
Lost Work Time
Missed work due to LBP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startApr 2011
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
- Investigators
- Julie M Fritz, PT, PhD, Principal investigator, University of Utah and Intermountain Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726803
- Sponsor's protocol ID
- 1R18HS018672
- Status last verified
- Dec 2017
- First submitted
- 8 Nov 2012
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sisco-Taylor BL, Magel JS, McFadden M, Greene T, Shen J, Fritz JM. Changes in Pain Catastrophizing and Fear-Avoidance Beliefs as Mediators of Early Physical Therapy on Disability and Pain in Acute Low-Back Pain: A Secondary Analysis of a Clinical Trial. Pain Med. 2022 May 30;23(6):1127-1137. doi: 10.1093/pm/pnab292.
PubMed 34613379Magel J, Fritz JM, Greene T, Kjaer P, Marcus RL, Brennan GP. Outcomes of Patients With Acute Low Back Pain Stratified by the STarT Back Screening Tool: Secondary Analysis of a Randomized Trial. Phys Ther. 2017 Mar 1;97(3):330-337. doi: 10.2522/ptj.20160298.
PubMed 28204740Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648.
PubMed 26461996
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Management Strategies for Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT01726803
- Acronym / sponsor ID
- 1R18HS018672
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Primary Care, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareUsual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks. |
| Early Physical Therapy with Usual Care | Experimental | Other: Early Physical Therapy with Usual Care, Other: Usual CareThe Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise. |
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, are originating from tissues of the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Both of the following clinical decision rule criteria: a)Duration of current symptoms < 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.
Key exclusion criteria (7 listed)
- Prior surgery to the lumbosacral spine
- Any treatment for low back pain in past 6 months
- Current pregnancy
- Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
- Presence of neurogenic LBP defined as the presence of either of the following:
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 |
|---|---|---|
| Early Physical Therapy with Usual CareThe early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only. | Other | Early Physical Therapy with Usual Care |
| Usual CareThe usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress. | Other | Early Physical Therapy with Usual Care, Usual Care |
Primary outcome
Oswestry Disability Index
Time frame: 3 months
10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability.
7 secondary outcomes
Numeric Pain Rating
Time frame: 3 months
EQ-5D
Time frame: 3 months
Fear-Avoidance Beliefs Questionnaire (Work Subscale)
Time frame: 3 months
Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)
Time frame: 3 months
Health Care Utilization (MRI)
Time frame: 12 months
Pain Catastrophizing
Time frame: 3 months
Lost Work Time
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34613379Sisco-Taylor BL, Magel JS, McFadden M, Greene T, Shen J, Fritz JM. Changes in Pain Catastrophizing and Fear-Avoidance Beliefs as Mediators of Early Physical Therapy on Disability and Pain in Acute Low-Back Pain: A Secondary Analysis of a Clinical Trial. Pain Med. 2022 May 30;23(6):1127-1137. doi: 10.1093/pm/pnab292.
- Derived from this study: PubMed 28204740Magel J, Fritz JM, Greene T, Kjaer P, Marcus RL, Brennan GP. Outcomes of Patients With Acute Low Back Pain Stratified by the STarT Back Screening Tool: Secondary Analysis of a Randomized Trial. Phys Ther. 2017 Mar 1;97(3):330-337. doi: 10.2522/ptj.20160298.
- Derived from this study: PubMed 26461996Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648.
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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, PT, PhD principal investigator
University of Utah and Intermountain Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Low Back Pain, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Index (time frame: 3 months). 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 NCT01726803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.