Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis

NCT01995461 | Terminated Results

• 1 other identifier: FAR10112
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Pain Score at 6 Months

  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

  baseline (pre-1st injection) to 6 months post-1st injection

Secondary Outcomes (2)

• Change From Baseline Swiss Spinal Stenosis Score at 6 Months

  baseline (pre-1st injection) to 6 months post-1st injection

• Change From Baseline Oswestry Disability Index at 6 Months

  baseline (pre-1st injection) to 6 months post-1st injection

Other Outcomes (1)

• Change From Baseline Pain Medication Need/Use at 6 Months

  baseline (pre-1st injection) to 6 months post-1st injection

Study Arms (1)

BTESI

EXPERIMENTAL

a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)

Drug: bilateral transforaminal epidural steroid injections

Interventions

bilateral transforaminal epidural steroid injections DRUG

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.

Also known as: BTESI

BTESI

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marshfield Clinic Research Foundation: lead

Study Sites (1)

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Rachel Stankowski
• Organization: Marshfield Clinic Research Foundation

stankowski.rachel@mcrf.mfldclin.edu

715-389-3442

Study Officials

• Mustafa Farooque, MD

  Marshfield Clinic/MCRF

  PRINCIPAL INVESTIGATOR

• James Burmester, PhD

  Marshfield Clinic Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff Physician/Clinician

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 26, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 24, 2015
• Results First Posted: November 24, 2015

Record last verified: 2015-10

Locations

US (1)