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Trial record 20 of 21 for:    "Bone Disease" | "Methylprednisolone"

Comparison of the Order of Treatment in Lumbar Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT02103543
Recruitment Status : Withdrawn (Lack of recruitment)
First Posted : April 4, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Hassan Monfared MD, Emory University

Brief Summary:
Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Both treatments are usually helpful in patients with back pain with spinal stenosis. However, physicians and other healthcare providers don't know which treatment is better to give first. The purpose of this research is to answer that question. Patients enrolled in this study will receive both treatments: physical therapy (PT) and a steroid injection ("shot"). However, patients may get the shot first followed by PT, or they may have PT first, followed by the shot. Their time in this study will last up to 6 months, and there will be five outcome measurements (via visits or telephone). All study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization computer program.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Other: physical therapy Procedure: lumbar interlaminar epidural steroid injection Drug: epidural steroid injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial in Patients With Lumbar Spinal Stenosis, Comparing the Order of Treatment With Epidural Corticosteroid Injections and Physical Therapy
Estimated Study Start Date : January 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physical Therapy first
patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection
Other: physical therapy
physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions

Procedure: lumbar interlaminar epidural steroid injection
single lumbar interlaminar epidural steroid injection

Drug: epidural steroid injection
Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)

Active Comparator: lumbar epidural steroid first
lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions
Other: physical therapy
physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions

Procedure: lumbar interlaminar epidural steroid injection
single lumbar interlaminar epidural steroid injection

Drug: epidural steroid injection
Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)




Primary Outcome Measures :
  1. Oswestry disability Index [ Time Frame: 1 year ]
    measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year


Secondary Outcome Measures :
  1. visual analog scale [ Time Frame: 1 year ]
    measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: chronic low back pain (at least 3 months in duration), a Visual Analogue Scale (VAS) greater than 30 (on a 100 point scale), between the ages of 18 to 80 years, either without radiating leg pain (below the knees) or with low back and/or buttock pain greater than leg pain (in which case the VAS for leg pain must be 20 or less), ability to read English and complete the assessment instruments, and diagnosis of lumbar spinal stenosis by a board certified radiologist or a board certified physiatrist either by magnetic resonance imaging (MRI) or computed-tomography (CT) that has previously been done as part of a normal course of patients medical treatment. All underlying etiology or diagnoses that are the source for lumbar spinal stenosis will be recorded (e.g. spondylolisthesis, herniated or degenerative discs, spondylosis).

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Exclusion Criteria:

  • history of lumbar surgery, acute disc herniation as reported on a radiologic imaging report, acute or severe chronic illness that are unstable, cognitive impairment which prevents the patient from providing accurate data or giving informed consent, neurological conditions (e.g. stroke, Parkinson's, brain injury), lower extremity amputees, fibromyalgia or chronic generalized pain, unstable opioid use or any signs or evidence of alcohol dependence or illicit drug use (as determined by screening questionnaire), clinical suspicion of facet joint-originating back pain or a positive response to prior facet joint block, lumbar epidural steroid injections within the last 6 months, uncontrolled psychiatric disorders, serious concomitant medical illness (e.g. acute heart failure, acute renal failure) or severe pain that may impair patient's ability to participate in physical therapy exercises or pain that is deemed so severe such that withholding of an ESI until after completion of the PT exercises is seen as causing unreasonable suffering to the patient, and conditions that would prevent the patient from undergoing fluoroscopy (e.g. pregnancy).

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): NCT02103543


Locations
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United States, Georgia
Atlanta Veterans Affairs Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
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Study Director: Hassan Monfared, MD Emory University

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Responsible Party: Hassan Monfared MD, Assistant Professor, Program Director, Emory University
ClinicalTrials.gov Identifier: NCT02103543     History of Changes
Other Study ID Numbers: IRB00061868
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases