RadiculopathyPhase 3NCT01073995
The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery
A Phase 3 study testing Kenalog and Sensorcaine in people with Radiculopathy, run by Horizon Health Network at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy
- What is being tested?
- Kenalog and Sensorcaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Systemic infection
- Idiopathic thrombocytopenic purpura
- Cerebrospinal diseases
- Pregnancy and nursing mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations
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.
Read the 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
- Being tested
- Kenalog and Sensorcaine
- Keywords
- Radiculopathy, Sciatica, Lumbar Disc Herniation, Surgical Alternative
- Medical subject headings
- Radiculopathy, Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kenalog and SensorcaineDrug
Also called Kenalog, Triamcinolone, Sensorcaine, Marcaine
Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Kenalog and Sensorcaine |
| Saline | Placebo comparator | Saline injections will be used to mimic the Steroid dose Receives: Drug: Kenalog and Sensorcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. neil Manson, Horizon Health Network
- Investigators
- Neil A Manson, MD, Principal investigator, Canada East Spine CentreErin E Bigney, MA, Study director, Canada East Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073995
- Sponsor's protocol ID
- 2009-1376
- Status last verified
- Sep 2016
- First submitted
- 22 Feb 2010
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Manuscript preparation in progress
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations
- ClinicalTrials.gov ID
- NCT01073995
- Acronym / sponsor ID
- 2009-1376
- Conditions
- Radiculopathy
- Keywords
- Radiculopathy, Sciatica, Lumbar Disc Herniation, Surgical Alternative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kenalog and Sensorcaine | Active comparator | Drug: Kenalog and SensorcaineThe 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 |
| Saline | Placebo comparator | Drug: Kenalog and SensorcaineSaline injections will be used to mimic the Steroid dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kenalog and SensorcaineAlso: Kenalog, Triamcinolone, Sensorcaine, MarcaineKenalog: 40 mg/ml Sensorcaine 0.25%: 1cc | Drug | Kenalog and Sensorcaine, Saline |
Primary outcome
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
1 secondary outcome
Subjective questionnaires
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Individual participant dataSharing planned: Yes. Manuscript preparation in progress
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil A Manson, MD principal investigator
Canada East Spine Centre
Erin E Bigney, MA study director
Canada East Spine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kenalog and Sensorcaine in people with Radiculopathy, run by Horizon Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Avoidance (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.