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

NCT01073995 | Completed Phase 3 DMC

• 1 other identifier: 2009-1376
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy

Keywords

Radiculopathy; Sciatica; Lumbar Disc Herniation; Surgical Alternative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective questionnaires

  5 Years

Study Arms (2)

Kenalog and Sensorcaine

ACTIVE COMPARATOR

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

Saline

PLACEBO COMPARATOR

Saline injections will be used to mimic the Steroid dose

Drug: Kenalog and Sensorcaine

Interventions

Kenalog and Sensorcaine DRUG

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

Also known as: Kenalog, Triamcinolone, Sensorcaine, Marcaine, Bupivacaine hydrochloride

Kenalog and Sensorcaine; Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Horizon Health Network: lead

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

MeSH Terms

Conditions

Radiculopathy; Sciatica; Intervertebral Disc Displacement

Interventions

Triamcinolone Acetonide; Bupivacaine; Triamcinolone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Neil A Manson, MD

  Canada East Spine Centre

  PRINCIPAL INVESTIGATOR

• Erin E Bigney, MA

  Canada East Spine Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)