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Management Strategies for Patients With Low Back Pain and Sciatica

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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

Tracking Information
First Submitted Date  ICMJE January 12, 2015
First Posted Date  ICMJE March 18, 2015
Results First Submitted Date  ICMJE October 6, 2020
Results First Posted Date  ICMJE December 24, 2020
Last Update Posted Date January 22, 2021
Study Start Date  ICMJE February 2015
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
Change From Baseline in Oswestry Disability Index [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
Change From Baseline in Oswestry Disability Index [ Time Frame: 4 weeks, 6 months, 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
  • Change From Baseline in Numeric Pain Ratings [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
  • Change From Baseline in Numeric Pain Ratings [ Time Frame: 4 weeks, 6 months, 1 year ]
    Separate rating for low back and leg pain intensity
  • Change From Baseline in EQ-5D [ Time Frame: 4 weeks, 6 months, 1 year ]
Current Other Pre-specified Outcome Measures
 (submitted: December 30, 2020)
  • Change From Baseline in Fear-Avoidance Beliefs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: monthly throughout 12 month follow-up period ]
    collected via online diaries
Original Other Pre-specified Outcome Measures
 (submitted: March 11, 2015)
  • Change from Baseline in Fear-avoidance beliefs [ Time Frame: 4 weeks, 6 months, 1 year ]
    Beliefs about physical activity and work on separate scales
  • Change from Baseline in Pain Catastrophizing Scale [ Time Frame: 4 weeks, 6 months, 1 year ]
  • Healthcare utilization and costs [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months ]
    collected via cost diaries online
 
Descriptive Information
Brief Title  ICMJE Management Strategies for Patients With Low Back Pain and Sciatica
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Sciatica
  • Physical Therapy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Education and re-assurance
  • 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.
    Interventions:
    • Behavioral: Education and re-assurance
    • Procedure: Physical Therapy
Publications * Fritz JM, Lane E, McFadden M, Brennan G, Magel JS, Thackeray A, Minick K, Meier W, Greene T. Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial. Ann Intern Med. 2021 Jan;174(1):8-17. doi: 10.7326/M20-4187. Epub 2020 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2015)
220
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02391350
Other Study ID Numbers  ICMJE R18HS022641( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Fritz, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP