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

NCT ID: NCT01073995

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-11-30

Brief 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.

Conditions

Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Kenalog and Sensorcaine

Intervention Type: DRUG

Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc

Saline

Saline injections will be used to mimic the Steroid dose

Group Type: PLACEBO_COMPARATOR

Kenalog and Sensorcaine

Intervention Type: DRUG

Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc

Interventions

Kenalog and Sensorcaine

Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc

Intervention Type: DRUG

Other Intervention Names

Kenalog; Triamcinolone; Sensorcaine; Marcaine; Bupivacaine hydrochloride

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon Health Network

OTHER

Sponsor Role: lead

Responsible Party

Dr. neil Manson

Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil A Manson, MD

Role: PRINCIPAL_INVESTIGATOR

Canada East Spine Centre

Erin E Bigney, MA

Role: STUDY_DIRECTOR

Canada East Spine Center

Locations

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Countries

Canada

Other Identifiers

2009-1376

Identifier Type: -

Identifier Source: org_study_id