The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery

The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations

The median Orthopaedic surgery wait time in Canada is 36.7 weeks (Esmail 2008), thus there is a need to find alternative treatments for pathologies such as lumbar disc herniations (LDH). The literature has demonstrated that selective nerve root injections (SNRI) are able to alleviate sciatic symptoms caused by LDH (Riew 2006) and may be beneficial as an alternative to surgery. It is necessary to determine whether SNRIs provide significant symptom resolution alleviating the need for surgery, or to determine if their success is transient and delays the time to surgery. The purpose of the proposed study is to evaluate the success of SNRI in patients suffering with LDH and to determine which factors influence outcome. Over the span of 2 years, data from 100 patients will be collected. These patients will be surgical candidates and have exhausted all non-operative measures prior to receiving a SNRI. Upon first assessment, each eligible patient will be randomly assigned to the treatment (steroid) or control (saline) group. The patient and all treating physicians will be blinded to the treatment given. Each patient will be followed over their course of treatment and information pertaining to their pain and symptoms will be recorded using standard questionnaires. Patient demographics, diagnosis, Worker's Compensation status, spinal levels treatment/outcome, and time from referral to treatment will also be evaluated. The primary outcome measure will be defined as the avoidance of surgery.

Study Overview

• Status: Completed
• Conditions: Radiculopathy
• Intervention / Treatment: Drug: Kenalog and Sensorcaine

Detailed Description

Patient Selection: All patients (ages 18-65 years) who have been diagnosed with lower extremity radiculopathy (sciatica) secondary to a lumbar disc herniation that have been referred for SNRI by the principal investigator (Dr. Neil Manson) will be asked to participate in the study. All patients will have exhausted non-operative measures.

Initial Assessment: During the initial office visit, patients will be assessed by the principle investigator for inclusion in the study. If the patient demonstrates interest in the proposed research they will be provided a Consent Form and given the opportunity to ask a Research Assistant questions regarding their participation.

. Injections: Standard procedures for SNRI will be used by the participating Radiologists in the Department of Radiology at the Saint John Regional Hospital. Each patient will be randomly assigned by a Research Assistant to either the treatment (Kenalog/Sensorcaine) or control (Saline) group. All treatments will be blinded to the treating physicians and the patient.

Injectates: Control Group: Saline Treatment Group: Kenalog 40cc/0.25% Sensorcaine

Follow up assessment: During a follow-up visit, patients will be re-assessed to determine the success of the injection. SNRI success will be determined by self-reported pain and symptom reduction. If the patient and principle investigator do not deem the injection successful, further treatment options will be discussed (second injection, surgery, etc) and follow-up evaluations will be scheduled.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18-65
• Diagnosed with lower extremity radiculopathy (sciatica) secondary to a lumbar disc herniation
• Exhausted non-operative measures:
• Medication has not been helpful in treating the patient's pain/symptoms
• Modification of daily activities has not been helpful in treating the patient's pain/symptoms
• Physiotherapy has not been helpful in treating the patient's pain/symptoms.
• Patient of the Investigator
• Patient willing to proceed with surgical intervention

Exclusion Criteria:

• Age: < 18 or > 65
• Any patient who has not attempted conservative non-operative treatment for a minimum of 6 weeks
• Any patient who has not been deemed a surgical candidate
• Any patient who has a contraindication for surgery
• Any patient who has a contraindication for Kenalog or Sensorcaine
• Known sensitivity to medicinal or non-medicinal ingredients
• Systemic infection
• Idiopathic thrombocytopenic purpura
• Cerebrospinal diseases
• Pregnancy and nursing mothers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Kenalog and Sensorcaine; The following drugs will be administered during a one time injection of the appropriate spinal level based off clinical and radiographic information: Intervention: Kenalog 40 mg/ml and Sensorcaine 0.25% 1cc	Drug: Kenalog and Sensorcaine; Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc; Other Names: Marcaine; Triamcinolone; Sensorcaine; Kenalog; Bupivacaine hydrochloride
PLACEBO_COMPARATOR: Saline; Saline injections will be used to mimic the Steroid dose	Drug: Kenalog and Sensorcaine; Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc; Other Names: Marcaine; Triamcinolone; Sensorcaine; Kenalog; Bupivacaine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Avoidance	After a minimum 1 year follow-up of an SNRI, a statistical analysis will be conducted to determine group differences in surgical necessity	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective questionnaires	Each patient will be followed over their course of treatment and information pertaining to their pain and symptoms will be recorded using standard questionnaires such as the SF-36 Questionnaire, the Oswestry Disability Index, and the Visual Analogue Scale. Patient demographics, diagnosis, Worker's Compensation status, spinal levels treatment/outcome, and time from referral to treatment will also be evaluated.	5 Years

Collaborators and Investigators

• Sponsor: Horizon Health Network
• Investigators: Principal Investigator: Neil A Manson, MD, Canada East Spine Centre; Study Director: Erin E Bigney, MA, Canada East Spine Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (ESTIMATE): February 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Sciatica; Radiculopathy; Lumbar Disc Herniation; Surgical Alternative
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Bupivacaine
• Other Study ID Numbers: 2009-1376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Manuscript preparation in progress