Low Back Pain, Physical Therapy, Sciatica
Conditions
Brief summary
Low back pain and sciatica is a common condition resulting in high costs and disability for society and affected individuals. Presently there is a lack of evidence for what treatments may help this condition early in the course of care. Improved early management could reduce risks for persistent disability and high costs. The goal of this project is to examine the clinical outcomes and costs associated with adding a physical therapy program to early management of patients with low back pain and sciatica within primary care.
Detailed description
Low back pain (LBP) is a common and costly condition. When accompanied by sciatica, risks for persistent disability and future invasive treatments increase. Most patients with LBP and sciatica enter the healthcare system in primary care. Optimal primary care management is currently unclear and little data are available to assist clinicians and inform patients of the likely effects of common options. Practice guidelines agree that imaging, spinal injections and surgeries should be reserved for patients whose symptoms do not diminish within 4-8 weeks, yet utilization rates for these procedures are increasing rapidly, partly due to the uncertainty of what options may be offered to patients for initial treatment. Physical therapy is considered an option in the initial management period, but is used inconsistently. It is currently unclear what can be expected from early physical therapy for patients with LBP and sciatica, and what if any long-term effect it may have on clinical outcomes or future healthcare utilization. The investigators research team has conducted a series of clinical trials to clarify the evidence for the most effective physical therapy procedures for patients with LBP and sciatica, and is now in a position to evaluate if the use of early, evidence-based physical therapy can reduce the risk of future disability, healthcare utilization and costs. The proposed study is a randomized trial comparing the effectiveness of usual, guideline-based initial management of newly consulting patients with LBP with sciatica with or without the addition of early physical therapy. Specific aims are to compare the clinical effectiveness, costs (direct and indirect), and cost-effectiveness of the addition of physical therapy. All patients will be managed with advice, education and medication. One group will also receive 6-8 sessions of physical therapy Outcomes will include measures of disability, pain, psychological distress, healthcare, utilization, and costs over 1 year. This study will permit an examination of the effectiveness and costs associated with the use of early physical therapy within primary care for patients with acute LBP and sciatica. The results of this study will provide needed information to assist clinicians and inform patients of their options for initial management of this common condition.
Interventions
BEHAVIORALEducation and re-assurance
Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
PROCEDUREPhysical Therapy
Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
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
1. Symptoms of pain and/or numbness between the 12th rib and buttocks, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region. 2. Symptoms of pain and/or numbness primarily into one leg that have extended below the knee in the last 72 hours, and correspond to a lower lumbar nerve root distribution (L4, L5, S1) 3. Current symptoms present for 90 days or fewer 4. Oswestry disability score \> 20% 5. One or more of the following symptoms: * Positive ipsilateral or contralateral straight leg raise test (reproduction of symptoms at \<70 degrees) * Reflex, sensory, or strength deficits in a pattern consistent with lower lumbar nerve root
Exclusion criteria
1. Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past year 2. Current pregnancy 3. Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.) or any treatment for LBP in prior 6 months. 4. Judgment of primary care provider of red flags of a potentially serious condition including cauda equina, major or rapidly progressing neurologic deficit, fracture, cancer, infection or systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oswestry Disability Index | Baseline, 4 weeks, 6 months, 1 year | Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Numeric Pain Ratings | Baseline, 4 weeks, 6 months, 1 year | Separate rating for low back pain and leg pain intensity on a 0-10 scale. Higher numbers indicate greater pain intensity. |
| Change From Baseline in EQ-5D | Baseline, 4 weeks, 6 months, 1 year | Self-report measure of Quality of Life. Scores range from 0 - 1.0, with higher scores indicating greater quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fear-Avoidance Beliefs | Baseline, 4 weeks, 6 months, 1 year | Fear Avoidance Beliefs about physical activity and work on separate scales. The Fear avoidance about physical activity scale assesses participants' concern that physical activity will harm their back. Scores range from 0-24 with higher scores indicating greater fear of physical activity. The Fear avoidance about work scale assesses participants' concern that work-related activity will harm their back. Scores range from 0-42 with higher scores indicating greater fear of physical activity. |
| Change From Baseline in Pain Catastrophizing Scale | Baseline, 4 weeks, 6 months, 1 year | Self-reported measure assessing the extent to which a participant experiences catastrophizing cognitions about back pain (e.g., feelings of helplessness, hypervigilance etc.). Scores range from 13-52 with higher numbers indicating greater catastrophizing cognitions. |
| Number of Participants Utilizing Healthcare | monthly throughout 12 month follow-up period | collected via online diaries |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from February 2015 through October, 2018. Recruitment was done in 2 health systems (University of Utah and Intermountain Healthcare) in Salt Lake City, Utah. Potential participants were identified using electronic health records and were sent a letter about the study after completing a primary care visit. A research team made follow-up telephone calls to identify those interested in meeting with a research assistant to determine eligibility and provide consent.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active. | 110 |
| Early Intervention Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms. | 110 |
| Total | 220 |
Baseline characteristics
| Characteristic | Early Intervention | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 11.2 | 39.0 years STANDARD_DEVIATION 11.2 | 37.9 years STANDARD_DEVIATION 11.2 |
| Back Pain Intensity Rating | 5.1 units on a 0-10 scale STANDARD_DEVIATION 1.8 | 5.0 units on a 0-10 scale STANDARD_DEVIATION 1.9 | 4.8 units on a 0-10 scale STANDARD_DEVIATION 1.9 |
| Duration of Symptoms | 35.8 days STANDARD_DEVIATION 25.6 | 35.8 days STANDARD_DEVIATION 26.1 | 35.9 days STANDARD_DEVIATION 26.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 30 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants | 165 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 25 Participants | 10 Participants |
| Euroqol 5 Dimensions (EQ-5D) | 0.64 units on a scale STANDARD_DEVIATION 0.2 | 0.64 units on a scale STANDARD_DEVIATION 0.2 | 0.64 units on a scale STANDARD_DEVIATION 0.2 |
| Fear-Avoidance Beliefs - Physical Activity | 15.2 units on a scale STANDARD_DEVIATION 5.7 | 14.6 units on a scale STANDARD_DEVIATION 5.8 | 14.0 units on a scale STANDARD_DEVIATION 5.9 |
| Fear-Avoidance Beliefs - Work | 15.4 units on a scale STANDARD_DEVIATION 12.3 | 14.6 units on a scale STANDARD_DEVIATION 12 | 13.9 units on a scale STANDARD_DEVIATION 11.8 |
| Leg Pain Intensity Rating | 4.3 units on a 0-10 scale STANDARD_DEVIATION 2.2 | 4.1 units on a 0-10 scale STANDARD_DEVIATION 2.2 | 3.8 units on a 0-10 scale STANDARD_DEVIATION 2.2 |
| Oswestry Disability Index | 38.9 units on a scale STANDARD_DEVIATION 13.8 | 37.3 units on a scale STANDARD_DEVIATION 14.9 | 35.8 units on a scale STANDARD_DEVIATION 15.8 |
| Pain Catastrophizing Scale | 20.9 units on a scale STANDARD_DEVIATION 12.6 | 19.9 units on a scale STANDARD_DEVIATION 12.3 | 19.0 units on a scale STANDARD_DEVIATION 11.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 92 Participants | 181 Participants | 89 Participants |
| Sex: Female, Male Female | 48 Participants | 107 Participants | 59 Participants |
| Sex: Female, Male Male | 61 Participants | 112 Participants | 51 Participants |
| StartBack Risk Category High Risk | 26 Participants | 54 Participants | 28 Participants |
| StartBack Risk Category Low Risk | 16 Participants | 35 Participants | 19 Participants |
| StartBack Risk Category Medium Risk | 68 Participants | 131 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 110 |
| other Total, other adverse events | 17 / 110 | 19 / 110 |
| serious Total, serious adverse events | 0 / 110 | 0 / 110 |
Outcome results
Primary
Change From Baseline in Oswestry Disability Index
Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability.
Time frame: Baseline, 4 weeks, 6 months, 1 year
Population: Missing data across follow-up is outlined by group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Change From Baseline in Oswestry Disability Index | 4 Weeks | -8.8 units on a scale |
| Usual Care | Change From Baseline in Oswestry Disability Index | 6 months | -17.0 units on a scale |
| Usual Care | Change From Baseline in Oswestry Disability Index | 1 year | -17.7 units on a scale |
| Early Intervention | Change From Baseline in Oswestry Disability Index | 4 Weeks | -17.0 units on a scale |
| Early Intervention | Change From Baseline in Oswestry Disability Index | 6 months | -22.4 units on a scale |
| Early Intervention | Change From Baseline in Oswestry Disability Index | 1 year | -22.5 units on a scale |
Secondary
Change From Baseline in EQ-5D
Self-report measure of Quality of Life. Scores range from 0 - 1.0, with higher scores indicating greater quality of life.
Time frame: Baseline, 4 weeks, 6 months, 1 year
Population: Missing data noted across all follow-up points
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Change From Baseline in EQ-5D | EQ-5D 4 weeks | 0.05 score on a scale |
| Usual Care | Change From Baseline in EQ-5D | EQ-5D 6 months | 0.14 score on a scale |
| Usual Care | Change From Baseline in EQ-5D | EQ-5D 1 year | 0.13 score on a scale |
| Early Intervention | Change From Baseline in EQ-5D | EQ-5D 4 weeks | 0.12 score on a scale |
| Early Intervention | Change From Baseline in EQ-5D | EQ-5D 6 months | 0.15 score on a scale |
| Early Intervention | Change From Baseline in EQ-5D | EQ-5D 1 year | 0.17 score on a scale |
Secondary
Change From Baseline in Numeric Pain Ratings
Separate rating for low back pain and leg pain intensity on a 0-10 scale. Higher numbers indicate greater pain intensity.
Time frame: Baseline, 4 weeks, 6 months, 1 year
Population: Missing data reflected across follow-up points
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Change From Baseline in Numeric Pain Ratings | Back pain intensity 4 weeks | -1.0 units on a scale |
| Usual Care | Change From Baseline in Numeric Pain Ratings | Back pain intensity 6 months | -1.5 units on a scale |
| Usual Care | Change From Baseline in Numeric Pain Ratings | Back pain intensity 1 year | -1.6 units on a scale |
| Usual Care | Change From Baseline in Numeric Pain Ratings | Leg pain intensity 4 weeks | -1.0 units on a scale |
| Usual Care | Change From Baseline in Numeric Pain Ratings | Leg pain intensity 6 months | -1.9 units on a scale |
| Usual Care | Change From Baseline in Numeric Pain Ratings | Leg pain intensity 1 year | -1.8 units on a scale |
| Early Intervention | Change From Baseline in Numeric Pain Ratings | Leg pain intensity 6 months | -1.8 units on a scale |
| Early Intervention | Change From Baseline in Numeric Pain Ratings | Back pain intensity 4 weeks | -2.4 units on a scale |
| Early Intervention | Change From Baseline in Numeric Pain Ratings | Leg pain intensity 4 weeks | -1.8 units on a scale |
| Early Intervention | Change From Baseline in Numeric Pain Ratings | Back pain intensity 6 months | -2.3 units on a scale |
| Early Intervention | Change From Baseline in Numeric Pain Ratings | Leg pain intensity 1 year | -2.2 units on a scale |
| Early Intervention | Change From Baseline in Numeric Pain Ratings | Back pain intensity 1 year | -2.6 units on a scale |
Other Pre-specified
Change From Baseline in Fear-Avoidance Beliefs
Fear Avoidance Beliefs about physical activity and work on separate scales. The Fear avoidance about physical activity scale assesses participants' concern that physical activity will harm their back. Scores range from 0-24 with higher scores indicating greater fear of physical activity. The Fear avoidance about work scale assesses participants' concern that work-related activity will harm their back. Scores range from 0-42 with higher scores indicating greater fear of physical activity.
Time frame: Baseline, 4 weeks, 6 months, 1 year
Population: Missing data noted across follow-up time points
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - physical activity, 4 weeks | -3.2 units on a scale |
| Usual Care | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - physical activity, 6 months | -4.9 units on a scale |
| Usual Care | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - physical activity, 1 year | -3.7 units on a scale |
| Usual Care | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - work, 4 weeks | -1.4 units on a scale |
| Usual Care | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - work, 6 months | -3.2 units on a scale |
| Usual Care | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - work, 1 year | -2.6 units on a scale |
| Early Intervention | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - work, 6 months | -5.0 units on a scale |
| Early Intervention | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - physical activity, 4 weeks | -4.9 units on a scale |
| Early Intervention | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - work, 4 weeks | -3.0 units on a scale |
| Early Intervention | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - physical activity, 6 months | -5.6 units on a scale |
| Early Intervention | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - work, 1 year | -6.2 units on a scale |
| Early Intervention | Change From Baseline in Fear-Avoidance Beliefs | Fear-Avoidance Beliefs - physical activity, 1 year | -7.3 units on a scale |
Other Pre-specified
Change From Baseline in Pain Catastrophizing Scale
Self-reported measure assessing the extent to which a participant experiences catastrophizing cognitions about back pain (e.g., feelings of helplessness, hypervigilance etc.). Scores range from 13-52 with higher numbers indicating greater catastrophizing cognitions.
Time frame: Baseline, 4 weeks, 6 months, 1 year
Population: Missing data reflected across time points
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Change From Baseline in Pain Catastrophizing Scale | Pain catastrophizing - 4 weeks | -3.7 units on a scale |
| Usual Care | Change From Baseline in Pain Catastrophizing Scale | Pain catastrophizing - 6 months | -6.7 units on a scale |
| Usual Care | Change From Baseline in Pain Catastrophizing Scale | Pain catastrophizing - 1 year | -7.8 units on a scale |
| Early Intervention | Change From Baseline in Pain Catastrophizing Scale | Pain catastrophizing - 6 months | -8.0 units on a scale |
| Early Intervention | Change From Baseline in Pain Catastrophizing Scale | Pain catastrophizing - 4 weeks | -5.6 units on a scale |
| Early Intervention | Change From Baseline in Pain Catastrophizing Scale | Pain catastrophizing - 1 year | -9.0 units on a scale |
Other Pre-specified
Number of Participants Utilizing Healthcare
collected via online diaries
Time frame: monthly throughout 12 month follow-up period
Population: Health care utilization over 1 year follow-up period. Participants are included in the analyses if at least one monthly utilization report was provided over the 12 month follow-up period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants Utilizing Healthcare | Lumbar spine surgery | 7 Participants |
| Usual Care | Number of Participants Utilizing Healthcare | Lumbar injections | 14 Participants |
| Usual Care | Number of Participants Utilizing Healthcare | Advanced Imaging | 31 Participants |
| Usual Care | Number of Participants Utilizing Healthcare | Emergency Department Visit | 11 Participants |
| Early Intervention | Number of Participants Utilizing Healthcare | Emergency Department Visit | 10 Participants |
| Early Intervention | Number of Participants Utilizing Healthcare | Lumbar spine surgery | 9 Participants |
| Early Intervention | Number of Participants Utilizing Healthcare | Advanced Imaging | 24 Participants |
| Early Intervention | Number of Participants Utilizing Healthcare | Lumbar injections | 15 Participants |