Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Management Strategies for Patients With Low Back Pain and Sciatica

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02391350
Recruitment Status : Completed
First Posted : March 18, 2015
Results First Posted : December 24, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Julie Fritz, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Low Back Pain
Sciatica
Physical Therapy
Interventions Behavioral: Education and re-assurance
Procedure: Physical Therapy
Enrollment 220
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.
Pre-assignment Details  
Arm/Group Title Usual Care Early Intervention
Hide 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 [1] 98 93
Not Completed 12 17
[1]
One-year follow-up
Arm/Group Title Usual Care Early Intervention Total
Hide 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 Number of Baseline Participants 110 110 220
Hide Baseline Analysis Population Description
Missing baseline scores; sex (n = 1 EPT), age (n = 1 UC), duration of symptoms (n = 1 UC), Numeric Pain Rating Scale-leg pain intensity (n = 1 EPT), Pain Catastrophizing Scale (n = 3 EPT, n = 2 UC), Fear-Avoidance Beliefs Questionnaire physical activity subscale (n = 1 UC) and work subscale (n = 4 EPT, n = 1 UC), and EQ-5D overall health rating (n = 6 EPT, n = 3 UC).
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 110 participants 219 participants
37.9  (11.2) 40.0  (11.2) 39.0  (11.2)
[1]
Measure Analysis Population Description: Age was missing for one participant in the usual care group.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 109 participants 219 participants
Female
59
  53.6%
48
  44.0%
107
  48.9%
Male
51
  46.4%
61
  56.0%
112
  51.1%
[1]
Measure Analysis Population Description: Gender missing for one participant in Early Intervention
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 110 participants 220 participants
Hispanic or Latino
16
  14.5%
14
  12.7%
30
  13.6%
Not Hispanic or Latino
84
  76.4%
81
  73.6%
165
  75.0%
Unknown or Not Reported
10
   9.1%
15
  13.6%
25
  11.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 110 participants 220 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   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 109 participants 110 participants 219 participants
35.9  (26.8) 35.8  (25.6) 35.8  (26.1)
[1]
Measure Analysis Population Description: Duration of symptoms data was missing for one participant in Usual Care at Baseline
StartBack Risk Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 110 participants 220 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%
[1]
Measure Description: The StartBack Risk Category describes the participant's risk for developing persistent low back pain based on physical and psychological factors. Risk stratification is based on participants' responses to 9 items about their physical and psychological symptom responses.
Oswestry Disability Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 110 participants 110 participants 220 participants
35.8  (15.8) 38.9  (13.8) 37.3  (14.9)
[1]
Measure Description: Measure of back pain-related disability. Scores range from 0-100 with higher scores indicating more disability due to low back pain.
Back Pain Intensity Rating   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a 0-10 scale
Number Analyzed 110 participants 110 participants 220 participants
4.8  (1.9) 5.1  (1.8) 5.0  (1.9)
[1]
Measure Description: Participant reported back pain intensity of 0-10 scale with higher numbers indicating greater pain intensity.
Leg Pain Intensity Rating   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a 0-10 scale
Number Analyzed 110 participants 109 participants 219 participants
3.8  (2.2) 4.3  (2.2) 4.1  (2.2)
[1]
Measure Description: Participant reported intensity of pain in the leg(s) on a 0-10 scale with higher numbers indicating greater pain intensity.
[2]
Measure Analysis Population Description: Leg pain intensity rating was missing at baseline for one participant in the Early Intervention group.
Euroqol 5 Dimensions (EQ-5D)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 107 participants 104 participants 211 participants
0.64  (0.20) 0.64  (0.20) 0.64  (0.20)
[1]
Measure Description: Participant reported measure of overall quality of life reported on five dimensions (mobility, self-care, depression/anxiety, pain/discomfort, usual activities). Scores range from 0 - 1.0 with higher scores indicating higher level of quality of life.
[2]
Measure Analysis Population Description: Baseline values were missing for 3 participants in Usual Care and 6 participants in Early Physical Therapy group.
Pain Catastrophizing Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
19.0  (11.9) 20.9  (12.6) 19.9  (12.3)
[1]
Measure Description: Participant-reported measure of the tendency to magnify the threat value of pain. Scores range from 13-52 with higher scores indicating a higher level of pain catastrophizing.
[2]
Measure Analysis Population Description: Pain Catastrophizing Scale was missing at baseline for 2 participants in Usual Care and 3 participants in Early Physical Therapy group.
Fear-Avoidance Beliefs - Physical Activity   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 109 participants 110 participants 219 participants
14.0  (5.9) 15.2  (5.7) 14.6  (5.8)
[1]
Measure Description: Participant reported measure of fear that physical activity will harm the back and should be avoided. Scores range from 0-24. Higher scores indicate greater levels of fear about physical activity.
[2]
Measure Analysis Population Description: Fear avoidance beliefs about physical activity data was missing for one participant in usual care group
Fear-Avoidance Beliefs - Work   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 109 participants 106 participants 215 participants
13.9  (11.8) 15.4  (12.3) 14.6  (12.0)
[1]
Measure Description: Participant reported measure of fear that work-related activities will harm the back and should be avoided. Scores range from 0-42. Higher scores indicate greater levels of fear about work-related activities.
[2]
Measure Analysis Population Description: The Fear Avoidance Beliefs about Work questionnaire was missing for 4 participants in the Early Intervention group and 1 participant in the Usual Care group.
1.Primary Outcome
Title Change From Baseline in Oswestry Disability Index
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data across follow-up is outlined by group
Arm/Group Title Usual Care Early Intervention
Hide 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.

Overall Number of Participants Analyzed 106 105
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4 Weeks Number Analyzed 106 participants 105 participants
-8.8
(-11.5 to -6.0)
-17.0
(-19.7 to -14.2)
6 months Number Analyzed 100 participants 96 participants
-17.0
(-19.9 to -14.2)
-22.4
(-25.3 to -19.6)
1 year Number Analyzed 98 participants 93 participants
-17.7
(-20.6 to -14.8)
-22.5
(-25.4 to -19.5)
2.Secondary Outcome
Title Change From Baseline in Numeric Pain Ratings
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data reflected across follow-up points
Arm/Group Title Usual Care Early Intervention
Hide 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.

Overall Number of Participants Analyzed 106 105
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Back pain intensity 4 weeks Number Analyzed 106 participants 105 participants
-1.0
(-1.4 to -0.60)
-2.4
(-2.8 to -2.1)
Back pain intensity 6 months Number Analyzed 100 participants 96 participants
-1.5
(-1.9 to -1.1)
-2.3
(-2.7 to -1.9)
Back pain intensity 1 year Number Analyzed 98 participants 93 participants
-1.6
(-2.0 to -1.2)
-2.6
(-3.0 to -2.2)
Leg pain intensity 4 weeks Number Analyzed 106 participants 105 participants
-1.0
(-1.4 to -0.6)
-1.8
(-2.3 to -1.4)
Leg pain intensity 6 months Number Analyzed 100 participants 96 participants
-1.9
(-2.3 to -1.5)
-1.8
(-2.2 to -1.3)
Leg pain intensity 1 year Number Analyzed 98 participants 93 participants
-1.8
(-2.2 to -1.3)
-2.2
(-2.7 to -1.8)
3.Secondary Outcome
Title Change From Baseline in EQ-5D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data noted across all follow-up points
Arm/Group Title Usual Care Early Intervention
Hide 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.

Overall Number of Participants Analyzed 106 105
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
EQ-5D 4 weeks Number Analyzed 106 participants 105 participants
0.05
(0.02 to 0.08)
0.12
(0.08 to 0.15)
EQ-5D 6 months Number Analyzed 100 participants 96 participants
0.14
(0.10 to 0.17)
0.15
(0.12 to 0.19)
EQ-5D 1 year Number Analyzed 98 participants 93 participants
0.13
(0.10 to 0.17)
0.17
(0.14 to 0.21)
4.Other Pre-specified Outcome
Title Change From Baseline in Fear-Avoidance Beliefs
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data noted across follow-up time points
Arm/Group Title Usual Care Early Intervention
Hide 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.

Overall Number of Participants Analyzed 106 105
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Fear-Avoidance Beliefs - physical activity, 4 weeks Number Analyzed 106 participants 105 participants
-3.2
(-4.4 to -2.0)
-4.9
(-6.1 to -3.7)
Fear-Avoidance Beliefs - physical activity, 6 months Number Analyzed 100 participants 96 participants
-4.9
(-6.1 to -3.6)
-5.6
(-6.9 to -4.3)
Fear-Avoidance Beliefs - physical activity, 1 year Number Analyzed 98 participants 93 participants
-3.7
(-5.0 to -2.5)
-7.3
(-8.6 to -6.0)
Fear-Avoidance Beliefs - work, 4 weeks Number Analyzed 106 participants 105 participants
-1.4
(-3.1 to 0.20)
-3.0
(-4.7 to -1.3)
Fear-Avoidance Beliefs - work, 6 months Number Analyzed 100 participants 96 participants
-3.2
(-4.9 to -1.4)
-5.0
(-6.8 to -3.3)
Fear-Avoidance Beliefs - work, 1 year Number Analyzed 98 participants 93 participants
-2.6
(-4.3 to -0.90)
-6.2
(-8.0 to -4.4)
5.Other Pre-specified Outcome
Title Change From Baseline in Pain Catastrophizing Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data reflected across time points
Arm/Group Title Usual Care Early Intervention
Hide 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.

Overall Number of Participants Analyzed 106 105
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Pain catastrophizing - 4 weeks Number Analyzed 106 participants 105 participants
-3.7
(-5.5 to -1.9)
-5.6
(-7.5 to -3.7)
Pain catastrophizing - 6 months Number Analyzed 100 participants 96 participants
-6.7
(-8.7 to -4.8)
-8.0
(-9.9 to -6.1)
Pain catastrophizing - 1 year Number Analyzed 98 participants 93 participants
-7.8
(-9.7 to -5.9)
-9.0
(-11.0 to -7.0)
6.Other Pre-specified Outcome
Title Number of Participants Utilizing Healthcare
Hide Description collected via online diaries
Time Frame monthly throughout 12 month follow-up period
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 109 108
Measure Type: Count of Participants
Unit of Measure: Participants
Lumbar spine surgery
7
   6.4%
9
   8.3%
Lumbar injections
14
  12.8%
15
  13.9%
Advanced Imaging
31
  28.4%
24
  22.2%
Emergency Department Visit
11
  10.1%
10
   9.3%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Early Intervention
Hide 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 (%) Affected / at Risk (%)
Total   0/110 (0.00%)      0/110 (0.00%)    
Hide Serious Adverse Events
Usual Care Early Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/110 (0.00%)      0/110 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Early Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/110 (15.45%)      19/110 (17.27%)    
Musculoskeletal and connective tissue disorders     
back surgery *  7/110 (6.36%)  7 9/110 (8.18%)  9
injections * [1]  14/110 (12.73%)  20 15/110 (13.64%)  25
*
Indicates events were collected by non-systematic assessment
[1]
Spinal injections
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julie Fritz
Organization: University of Utah
Phone: 8015872237
EMail: julie.fritz@utah.edu
Layout table for additonal information
Responsible Party: Julie Fritz, University of Utah
ClinicalTrials.gov Identifier: NCT02391350    
Other Study ID Numbers: R18HS022641 ( U.S. AHRQ Grant/Contract )
First Submitted: January 12, 2015
First Posted: March 18, 2015
Results First Submitted: October 6, 2020
Results First Posted: December 24, 2020
Last Update Posted: January 22, 2021