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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Health Network
• Treatments: Bupivacaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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