Management Strategies for Patients With Low Back Pain and Sciatica

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT02391350
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 220
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Sciatica; Physical Therapy	Behavioral: Education and re-assurance; Procedure: Physical Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.; Procedure: Physical Therapy; Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. Number of Participants Utilizing Healthcare [monthly throughout 12 month follow-up period]

   collected via online diaries

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Utah Healthcare System	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• University of Utah
• Agency for Healthcare Research and Quality (AHRQ)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 27, 2014
• Statistical Analysis Plan - Aug 13, 2020

More Information

Publications

None provided.

• Responsible Party: Julie Fritz, Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT02391350
• Other Study ID Numbers: R18HS022641
• First Posted: Mar 18, 2015
• Last Update Posted: Jan 22, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Sciatica; Back Pain; Low Back Pain

Study Results

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.

Arm/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	110	110
4-week Follow-up	106	105
6-month Follow-up	100	96
COMPLETED	98	93
NOT COMPLETED	12	17

Baseline Characteristics

Arm/Group Title	Usual Care	Early Intervention	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	110	110	220
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.9 (11.2)	40.0 (11.2)	39.0 (11.2)
Sex: Female, Male (Count of Participants)
Female	59 53.6%	48 43.6%	107 48.6%
Male	51 46.4%	61 55.5%	112 50.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 14.5%	14 12.7%	30 13.6%
Not Hispanic or Latino	84 76.4%	81 73.6%	165 75%
Unknown or Not Reported	10 9.1%	15 13.6%	25 11.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.8%	5 4.5%	7 3.2%
Asian	5 4.5%	2 1.8%	7 3.2%
Native Hawaiian or Other Pacific Islander	1 0.9%	1 0.9%	2 0.9%
Black or African American	3 2.7%	1 0.9%	4 1.8%
White	89 80.9%	92 83.6%	181 82.3%
More than one race	7 6.4%	7 6.4%	14 6.4%
Unknown or Not Reported	3 2.7%	2 1.8%	5 2.3%
Duration of Symptoms (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	35.9 (26.8)	35.8 (25.6)	35.8 (26.1)
StartBack Risk Category (Count of Participants)
High Risk	28 25.5%	26 23.6%	54 24.5%
Medium Risk	63 57.3%	68 61.8%	131 59.5%
Low Risk	19 17.3%	16 14.5%	35 15.9%
Oswestry Disability Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	35.8 (15.8)	38.9 (13.8)	37.3 (14.9)
Back Pain Intensity Rating (units on a 0-10 scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a 0-10 scale]	4.8 (1.9)	5.1 (1.8)	5.0 (1.9)
Leg Pain Intensity Rating (units on a 0-10 scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a 0-10 scale]	3.8 (2.2)	4.3 (2.2)	4.1 (2.2)
Euroqol 5 Dimensions (EQ-5D) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.64 (0.20)	0.64 (0.20)	0.64 (0.20)
Pain Catastrophizing Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	19.0 (11.9)	20.9 (12.6)	19.9 (12.3)
Fear-Avoidance Beliefs - Physical Activity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	14.0 (5.9)	15.2 (5.7)	14.6 (5.8)
Fear-Avoidance Beliefs - Work (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.9 (11.8)	15.4 (12.3)	14.6 (12.0)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Oswestry Disability Index
Description	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

Outcome Measure Data

Analysis Population Description

Missing data across follow-up is outlined by group

Arm/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Measure Participants	106	105
4 Weeks	-8.8	-17.0
6 months	-17.0	-22.4
1 year	-17.7	-22.5

2. Secondary Outcome

Title	Change From Baseline in Numeric Pain Ratings
Description	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

Outcome Measure Data

Analysis Population Description

Missing data reflected across follow-up points

Arm/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Measure Participants	106	105
Back pain intensity 4 weeks	-1.0	-2.4
Back pain intensity 6 months	-1.5	-2.3
Back pain intensity 1 year	-1.6	-2.6
Leg pain intensity 4 weeks	-1.0	-1.8
Leg pain intensity 6 months	-1.9	-1.8
Leg pain intensity 1 year	-1.8	-2.2

3. Secondary Outcome

Title	Change From Baseline in EQ-5D
Description	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

Outcome Measure Data

Analysis Population Description

Missing data noted across all follow-up points

Arm/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Measure Participants	106	105
EQ-5D 4 weeks	0.05	0.12
EQ-5D 6 months	0.14	0.15
EQ-5D 1 year	0.13	0.17

4. Other Pre-specified Outcome

Title	Change From Baseline in Fear-Avoidance Beliefs
Description	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

Outcome Measure Data

Analysis Population Description

Missing data noted across follow-up time points

Arm/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Measure Participants	106	105
Fear-Avoidance Beliefs - physical activity, 4 weeks	-3.2	-4.9
Fear-Avoidance Beliefs - physical activity, 6 months	-4.9	-5.6
Fear-Avoidance Beliefs - physical activity, 1 year	-3.7	-7.3
Fear-Avoidance Beliefs - work, 4 weeks	-1.4	-3.0
Fear-Avoidance Beliefs - work, 6 months	-3.2	-5.0
Fear-Avoidance Beliefs - work, 1 year	-2.6	-6.2

5. Other Pre-specified Outcome

Title	Change From Baseline in Pain Catastrophizing Scale
Description	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

Outcome Measure Data

Analysis Population Description

Missing data reflected across time points

Arm/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Measure Participants	106	105
Pain catastrophizing - 4 weeks	-3.7	-5.6
Pain catastrophizing - 6 months	-6.7	-8.0
Pain catastrophizing - 1 year	-7.8	-9.0

6. Other Pre-specified Outcome

Title	Number of Participants Utilizing Healthcare
Description	collected via online diaries
Time Frame	monthly throughout 12 month follow-up period

Outcome Measure Data

Analysis Population Description

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/Group Title	Usual Care	Early Intervention
Arm/Group Description	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.	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.
Measure Participants	109	108
Lumbar spine surgery	7 6.4%	9 8.2%
Lumbar injections	14 12.7%	15 13.6%
Advanced Imaging	31 28.2%	24 21.8%
Emergency Department Visit	11 10%	10 9.1%

Adverse Events

Time Frame	1 year
Arm/Group Title	Usual Care		Early Intervention
Arm/Group Description	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.		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.
All Cause Mortality
	Usual Care		Early Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/110 (0%)
Serious Adverse Events
	Usual Care		Early Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/110 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		Early Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/110 (15.5%)		19/110 (17.3%)
Musculoskeletal and connective tissue disorders
back surgery	7/110 (6.4%)	7	9/110 (8.2%)	9
injections	14/110 (12.7%)	20	15/110 (13.6%)	25

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.