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NCT Number: NCT01073995

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

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.

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Key information

Conditions

Radiculopathy Bone Diseases Hernia Intervertebral Disc Displacement Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kenalog and Sensorcaine

Drug

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

Other names: Kenalog, Triamcinolone, Sensorcaine, Marcaine, Bupivacaine hydrochloride

Primary outcomes

  1. Surgical Avoidance

    Time frame: 5 years

    After a minimum 1 year follow-up of an SNRI, a statistical analysis will be conducted to determine group differences in surgical necessity

Secondary outcomes

  1. Subjective questionnaires

    Time frame: 5 Years

    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.

Sponsors and collaborators

Lead sponsor

Horizon Health Network

Other

Registry information

Official study title

The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2010
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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