Low Back Pain
Conditions
Keywords
back pain, primary care, physical therapy
Brief summary
The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.
Detailed description
The specific aims of this study are the following: 1. Compare the effectiveness of two primary care management strategies for patients with a recent onset of combat-related LBP. We hypothesize early physical therapy access for these Soldiers will result in greater improvements in function and quality of life over 1 year as compared to a stepped care strategy. 2. Compare the subsequent healthcare utilization associated with two management strategies for patients with a recent onset combat-related LBP. We hypothesize early physical therapy access will result in decreased healthcare utilization over 1 year as compared to a stepped care strategy. 3. Evaluate the importance of psychosocial factors on outcomes within both groups of treatment.
Interventions
PROCEDUREUsual Care (UC)
Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress.
PROCEDUREEarly Physical Therapy (PT)
Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms).
Sponsors
U.S. Army Medical Research and Development Command
William Beaumont Army Medical Center
Madigan Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- * Military personnel on active duty and eligible for healthcare at a military treatment facility * A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region. * Duration of current episode of low back pain \< 90 days * Age 18 - 60 years (or emancipated minors on active duty) * Available for the following 4 weeks to complete a regimen of treatment
Exclusion criteria
* Oswestry Disability Index \< 20% * History of receiving any medical care for this episode of low back pain within the last 3 months * Prior surgery to the thoraco-lumbar spine or pelvis * This episode of back pain is due to a traumatic fracture * Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months. * Any red flags that would indicate a potentially serious condition or other significant disease process. These could include but not limited to cauda equina syndrome, large or rapidly progressing neurological deficit, fracture, cancer, ankylosing spondylitis, or other systemic disease. * Current episode occurred because of a motor vehicle accident * Currently pregnant (or history of pregnancy in the previous 6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Oswestry Disability Index | 12 months | The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | 12 months | A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability. Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference of two points among patients with acute LBP receiving physical therapy. |
| Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change) | 12 Months | The GRC is a 15-point scale that asks the patient to rate the degree of change in his or her condition from the beginning of treatment to the present. The mid-point of the scale is no change (0). Ratings from -1 to -7 represent varying degrees of a worsening of the patient's condition, while rating from +1 to +7 represent varying degrees of improvement. A score of 3 or higher is considered clinically meaningful change. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (UC) The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.
Usual Care (UC): Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress. | 61 |
| Early Physical Therapy (PT) All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.
Early Physical Therapy (PT): Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms). | 58 |
| Total | 119 |
Baseline characteristics
| Characteristic | Early Physical Therapy (PT) | Usual Care (UC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 61 Participants | 119 Participants |
| Age, Continuous | 29.1 years STANDARD_DEVIATION 6.7 | 26.9 years STANDARD_DEVIATION 6.3 | 28.1 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment United States | 58 participants | 61 participants | 119 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 50 Participants | 49 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 58 |
| other Total, other adverse events | 0 / 61 | 0 / 58 |
| serious Total, serious adverse events | 0 / 61 | 0 / 58 |
Outcome results
Primary
Modified Oswestry Disability Index
The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points.
Time frame: 12 months
Population: Active duty Soldiers in the United States Army
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care (UC) | Modified Oswestry Disability Index | 23.46 score on a scale |
| Early Physical Therapy (PT) | Modified Oswestry Disability Index | 24.26 score on a scale |
Secondary
Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)
The GRC is a 15-point scale that asks the patient to rate the degree of change in his or her condition from the beginning of treatment to the present. The mid-point of the scale is no change (0). Ratings from -1 to -7 represent varying degrees of a worsening of the patient's condition, while rating from +1 to +7 represent varying degrees of improvement. A score of 3 or higher is considered clinically meaningful change.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change) | 16 Participants |
| Early Physical Therapy (PT) | Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change) | 20 Participants |
Secondary
Numeric Pain Rating Scale (NPRS)
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability. Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference of two points among patients with acute LBP receiving physical therapy.
Time frame: 12 months
Population: Active duty Soldiers in US Army
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care (UC) | Numeric Pain Rating Scale (NPRS) | 3.7 units on a scale |
| Early Physical Therapy (PT) | Numeric Pain Rating Scale (NPRS) | 3.7 units on a scale |