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

Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073995
• Other study ID #: 2009-1376
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2010
• Last updated: September 28, 2016
• Start date: March 2010
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Horizon Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiculopathy

Intervention

Drug:
• Kenalog and Sensorcaine
Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc

Locations

Country	Name	City	State
Canada	Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Health Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subjective questionnaires	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.	5 Years	No