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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Horizon Health Network
Sponsor:
Information provided by (Responsible Party):
Dr. neil Manson, Horizon Health Network
ClinicalTrials.gov Identifier:
NCT01073995
First received: February 22, 2010
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Radiculopathy
Drug: Kenalog and Sensorcaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations

Resource links provided by NLM:


Further study details as provided by Horizon Health Network:

Primary Outcome Measures:
  • Surgical Avoidance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    After a minimum 1 year follow-up of an SNRI, a statistical analysis will be conducted to determine group differences in surgical necessity


Secondary Outcome Measures:
  • Subjective questionnaires [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

Drug: Kenalog and Sensorcaine
Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc
Other Names:
  • Kenalog
  • Triamcinolone
  • Sensorcaine
  • Marcaine
  • Bupivacaine hydrochloride
Placebo Comparator: Saline
Saline injections will be used to mimic the Steroid dose
Drug: Kenalog and Sensorcaine
Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc
Other Names:
  • Kenalog
  • Triamcinolone
  • Sensorcaine
  • Marcaine
  • Bupivacaine hydrochloride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073995

Contacts
Contact: Neil A Manson, MD 506-649-2667 neilmansonmd@yahoo.ca
Contact: Melissa D McKeon, MSc 506-608-9463 mckeon.melissa@gmail.com

Locations
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Neil A Manson, MD    506-649-2667    neilmansonmd@yahoo.com   
Principal Investigator: Neil A Manson, MD         
Sponsors and Collaborators
Horizon Health Network
Investigators
Principal Investigator: Neil A Manson, MD Canada East Spine Centre
  More Information

No publications provided

Responsible Party: Dr. neil Manson, Orthopaedic surgeon, Horizon Health Network
ClinicalTrials.gov Identifier: NCT01073995     History of Changes
Other Study ID Numbers: 2009-1376
Study First Received: February 22, 2010
Last Updated: February 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by Horizon Health Network:
Radiculopathy
Sciatica
Lumbar Disc Herniation
Surgical Alternative

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014