Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis

This study has been terminated.
(biostatistician determined 20 subjects would be adequate to perform statistics)
Sponsor:
Information provided by (Responsible Party):
Mustafa Farooque, MD, Marshfield Clinic Research Foundation
ClinicalTrials.gov Identifier:
NCT01995461
First received: November 18, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a bilateral TESI would probably be more beneficial.

To date, there have not been any well designed prospective studies to determine the effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC. Therefore, the goal of this prospective, non-randomized case-series outcome study is to evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving function in patients with DLSS. The hypothesis is that BTESI at the level below the most stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and improves function in patients with DLSS.


Condition Intervention
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Drug: bilateral transforaminal epidural steroid injections

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness of Bilateral Transforaminal Epidural Steroid Injections in Degenerative Lumbar Spinal Stenosis Patients With Neurogenic Claudication: A Prospective Outcome Study

Resource links provided by NLM:


Further study details as provided by Marshfield Clinic Research Foundation:

Primary Outcome Measures:
  • change from baseline pain score at 6 months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ] [ Designated as safety issue: No ]
    change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection


Secondary Outcome Measures:
  • change from baseline Swiss spinal stenosis score at 6 months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ] [ Designated as safety issue: No ]
    The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life.

  • change from baseline Oswestry Disability Index at 6 months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ] [ Designated as safety issue: No ]
    The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients.


Other Outcome Measures:
  • change from baseline pain medication need/use at 6 months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTESI
a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
Drug: bilateral transforaminal epidural steroid injections
BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Other Name: BTESI

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of back/buttock/leg pain (NOT radicular pain) in a neurogenic claudicatory fashion, relieved by stooping or sitting down, for at least 3 months with no or poor response to conservative treatment (analgesics, NSAIDs, or physical therapy)
  • Patients with bilateral buttock and/or bilateral lower extremity pain in a neurogenic fashion with or without lower back pain
  • Radiologic documentation of degree of degenerative lumbar spinal stenosis (DLSS)
  • MRI/CT showing at least moderate central canal spinal stenosis (neuro-radiologist definition) with symptoms correlating with stenosis (symptoms of back/buttock/leg pain without unilateral radicular pain in a neurogenic claudicatory fashion, relieved by stooping or sitting down)
  • Patients choosing to receive BTESI as their next treatment option, following discussions with their spine doctor
  • Patients who can give informed consent, could tolerate the procedure, and who are able to understand and answer the forms and questionnaires properly.

Exclusion Criteria:

  • Radiologic spinal stenosis without symptoms of spinal stenosis
  • Symptoms of neurogenic claudication without at least moderate degree of radiologic spinal stenosis
  • Patients with specific lumbo-sacral radicular symptoms or radiculopathy (radicular pain secondary to a single nerve root compression/inflammation; usually follows a specific dermatome in lower extremities; unilateral radiculopathy either from disc herniation or lateral recess stenosis)
  • Patients with vascular claudication (pain in the legs secondary to arterial insufficiency)
  • Previous lumbo-sacral surgery
  • Any condition that does not allow the patient to stand and/or walk for any length of time (e.g., COPD, severe lung disease, etc.)
  • Patients with symptomatic hip joint pathology concurrent with spinal stenosis
  • A coexisting musculoskeletal condition that would negate functional improvement from the injection (e.g., severe Parkinson disease, hemiparesis, etc.)
  • Malignancy or infection to the spine
  • Another pain generating condition that would mask the improvement provided by the injection
  • Patients who had lumbar epidural steroid injections within the past six months
  • Significant psychologic diagnosis and/or dementia
  • Patients receiving workman's compensation benefit
  • Patients unable to give consent on their own, or who are not able to understand and answer the forms and questionnaires, or their answers will not be reliable.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995461

Locations
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Marshfield Clinic Research Foundation
Investigators
Principal Investigator: Mustafa Farooque, MD Marshfield Clinic/MCRF
Principal Investigator: James Burmester, PhD Marshfield Clinic Research Foundation
  More Information

No publications provided

Responsible Party: Mustafa Farooque, MD, Medical Staff Physician/Clinician, Marshfield Clinic Research Foundation
ClinicalTrials.gov Identifier: NCT01995461     History of Changes
Other Study ID Numbers: FAR10112
Study First Received: November 18, 2013
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Intermittent Claudication
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014