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

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2015
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Sciatica

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Number of Participants Utilizing Healthcare [ Time Frame: monthly throughout 12 month follow-up period ]
    collected via online diaries



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391350


Locations
Layout table for location information
United States, Utah
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)
  Study Documents (Full-Text)

Documents provided by Julie Fritz, University of Utah:
Study Protocol  [PDF] October 27, 2014
Statistical Analysis Plan  [PDF] August 13, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Julie Fritz, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02391350    
Other Study ID Numbers: R18HS022641 ( U.S. AHRQ Grant/Contract )
First Posted: March 18, 2015    Key Record Dates
Results First Posted: December 24, 2020
Last Update Posted: January 22, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Sciatica
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia