The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery
Condition: Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      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: 
      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.
    

Intervention name(s): Kenalog and Sensorcaine
Intervention type(s): Drug
Intervention description(s): Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc
Other intervention name(s): Kenalog; Triamcinolone; Sensorcaine; Marcaine; Bupivacaine hydrochloride
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bupivacaine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radiculopathy; Sciatica; Lumbar Disc Herniation; Surgical Alternative