Low Back Pain
Conditions
Keywords
Low Back Pain, Primary Care, Physical Therapy
Brief 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. 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.
Interventions
OTHEREarly Physical Therapy with Usual Care
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.
OTHERUsual 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.
Sponsors
Intermountain Health Care, Inc.
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | 3 months | 10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 3 months | 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. |
| Fear-Avoidance Beliefs Questionnaire (Work Subscale) | 3 months | Measures fear-avoidance beliefs related to work. Scores range from 0-42 with higher numbers representing greater levels of fear avoidance beliefs about work. |
| Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome) | 3 months | 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. |
| Numeric Pain Rating | 3 months | 0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity. |
| Pain Catastrophizing | 3 months | 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. |
| Lost Work Time | 12 months | Missed work due to LBP |
| Health Care Utilization (MRI) | 12 months | Utilization of healthcare for low back pain (MRI utilization) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| 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. | 108 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Total | Early Physical Therapy With Usual Care |
|---|---|---|---|
| Age, Continuous | 36.5 Years STANDARD_DEVIATION 10.2 | 37.5 Years STANDARD_DEVIATION 10.3 | 38.3 Years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 18 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 202 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) White | 90 Participants | 179 Participants | 89 Participants |
| Region of Enrollment United States | 112 participants | 220 participants | 108 participants |
| Sex: Female, Male Female | 53 Participants | 115 Participants | 62 Participants |
| Sex: Female, Male Male | 59 Participants | 105 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 13 / 108 |
| serious Total, serious adverse events | 0 / 112 | 0 / 108 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Oswestry Disability Index | 9.8 units on a scale |
| Early Physical Therapy | Oswestry Disability Index | 6.6 units on a scale |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | EQ-5D | 0.88 units on a scale |
| Early Physical Therapy | EQ-5D | 0.91 units on a scale |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Fear-Avoidance Beliefs Questionnaire (Work Subscale) | 7.5 units on a scale |
| Early Physical Therapy | Fear-Avoidance Beliefs Questionnaire (Work Subscale) | 5.2 units on a scale |
Secondary
Health Care Utilization (MRI)
Utilization of healthcare for low back pain (MRI utilization)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Health Care Utilization (MRI) | 3 participants |
| Early Physical Therapy | Health Care Utilization (MRI) | 4 participants |
Secondary
Lost Work Time
Missed work due to LBP
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Lost Work Time | 46 participants |
| Early Physical Therapy | Lost Work Time | 40 participants |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Numeric Pain Rating | 1.8 units on a scale |
| Early Physical Therapy | Numeric Pain Rating | 1.4 units on a scale |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Pain Catastrophizing | 5.2 units on a scale |
| Early Physical Therapy | Pain Catastrophizing | 3.0 units on a scale |
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome) | 49 percentage of participants |
| Early Physical Therapy | Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome) | 64 percentage of participants |