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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Physical Therapy with Usual Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating | 0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
a) 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
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| Name | Affiliation | Role |
|---|---|---|
| Julie M Fritz, PT, PhD | University of Utah and Intermountain Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Health Care | Salt Lake City | Utah | 84106 | United States | ||
| The University of Utah Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34613379 | Derived | 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. | |
| 28204740 | Derived | Magel 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | 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. |
| FG001 | Early Physical Therapy With Usual Care | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual Care: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
Adverse events were recorded for physical therapy group after 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | 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. Early Physical Therapy: 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 Care: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| side effects of physical therapy | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patients reporting increased pain, spasm, stiffness, etc. following physical therapy treatment session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Fritz | University of Utah | 801-581-6861 | julie.fritz@hsc.utah.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Usual Care | Other | 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. |
|
| 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. | 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. | 3 months |
| Health Care Utilization (MRI) | Utilization of healthcare for low back pain (MRI utilization) | 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. | 3 months |
| Lost Work Time | Missed work due to LBP | 12 months |
| Salt Lake City |
| Utah |
| 84108 |
| United States |
| 26461996 | Derived | Fritz 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. |
| BG001 |
| Early Physical Therapy With Usual Care |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Early Physical Therapy | 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. Usual Care: 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. |
|
|
| Secondary | Numeric Pain Rating | 0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | Health Care Utilization (MRI) | Utilization of healthcare for low back pain (MRI utilization) | Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Secondary | Lost Work Time | Missed work due to LBP | Posted | Number | participants | 12 months |
|
|
|
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | Early Physical Therapy | 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. Usual Care: 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. | 0 | 108 | 13 | 108 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |