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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Radiculopathy

Intervention / Treatment
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* Drug: Kenalog and Sensorcaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kenalog and Sensorcaine<br>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<br>* Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc<br>* Other names: Bupivacaine hydrochloride;|
| Placebo Comparator: Saline<br>Saline injections will be used to mimic the Steroid dose | Drug: Kenalog and Sensorcaine<br>* Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc<br>* Other names: Bupivacaine hydrochloride;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiculopathy, Sciatica, Lumbar Disc Herniation, Surgical Alternative