Lumbar RadiculopathyNCT03543033
Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes
A study testing Corticosteroid injection in people with Lumbar Radiculopathy, run by Lahey Clinic at 1 site in United States.
Trial summary
This randomized control trial will compare opioid use, pain, and functional outcomes following decompression surgery for single-level lumbar radiculopathy in patients who undergo placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to those who do not. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 1 May 2020
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 30-75 years of age
- Patients diagnosed with diagnoses with single level unilateral lumbar radiculopathy
- Patients diagnosed with spinal stenosis or disc herniation
- Patients who have a history of > 6 weeks of at least 1 conservative treatment
- ASA < III
Who cannot join
- Patients who have undergone previous lumbar spinal surgery at index level
- Patients diagnosed with spondylolisthesis at index level
- Patients currently taking anti-coagulant therapy
- Active treatment of major psychiatric condition such as major depression and/or anxiety disorder.
- Patients currently seeking or receiving workers compensation
- Patients who have undergone previous corticosteroid injection at index level
Show all 10Show fewer
- Morbid obesity defined as BMI > 40
- Patients with history of chronic opioid use
- Patients with a contrast dye allergy
- Extruded disc fragment
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01803
About this study
Official title: Randomized Control Trial Comparing Pain and Functional Outcome Following Single Level Lumbar Nerve Decompression Surgery With or Without Preoperative Corticosteroid Epidural Injection
This randomized control trial will compare opioid use, pain, and functional outcomes following decompression surgery for single-level lumbar radiculopathy in patients who undergo placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to those who do not. The hypothesis of this study is that patients who receive the preoperative corticosteroid injection will have less reduced postoperative opioid use, as well as earlier mobilization, reduced length of stay, and faster return to work compared to control patients who do not receive the injection.
Read the detailed description
This is a randomized control study that will be completed within the Department of Neurosurgery at Lahey Hospital \& Medical Center. Patients will undergo their recommended surgery to treat single-level lumbar radiculopathy. Patients who are randomized to and consent to receiving a preoperative corticosteroid injection will report to clinic within 2 weeks prior to date of surgery to receive a corticosteroid injection. These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline. To assure the injection is epidural, we will be using loss of resistance technique under fluoroscopy and epidural placement will be confirmed with the live-image instillation in the AP and lateral positions of dye, with pattern confirming epidermal needle placement.
All patients will complete health outcome questionnaires (VAS, EQ-5D, ODI) at baseline (treatment cohort: prior to injection, control cohort: prior to spine surgery), 1 week post-op, 1 month post-op, and 3 months post-op. Patients will be instructed to bring all condition-related pain medication containers to each follow-up for research measuring purposes. Research personnel will record number of pills remaining in container, number of opioid prescription refills, and respective dates. Opioid usage for each subject will be tracked and converted to mg oral morphine equivalents using a standard table. Research personnel will capture additional clinic information such as length of stay, length of time before ambulation, and occurrence of any complications (i.e. DVT, infection). Opioid use, muscle relaxants, and other pain medication use will be followed for 3 months. At baseline and at each post-op follow up, patients will be asked to define their use of illicit drugs over the past 6 months (heroin, cocaine, marijuana, methamphetamine, other). Return to work date and work status will be captured out to 3 months. Patients will submit a health-cost diary at 1 week, 1 month, and 3 months, and this data will be combined with hospital-based cost information to generate a cost analysis. This diary will capture costs such as medication costs, copayments, travel, etc. Additionally, all patient surgery cancelations as well as reason for cancelation will be recorded. No additional medical testing will be required by the patient.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Corticosteroid injection
- Keywords
- lumbar radiculopathy, corticosteroid epidural injection
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injectionDrug
These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients will receive a corticosteroid epidural injection within 2 weeks of their scheduled lumbar surgery Receives: Drug: Corticosteroid injection |
| Control | No intervention | Patients will not receive a corticosteroid injection within 2 weeks of their scheduled lumbar surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use - conversion to oral morphine equivalents using standard table
Following spine surgery, # of prescription opioid pills used will be recorded and converted to oral morphine equivalents using a standard table. Information collected will include # of pills taken, # of prescription refills, and respective dates.
Measured: Primary endpoint is 3 Months
Secondary outcomes (3)
Disability - Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) will be used to measure disability associated with their spinal condition. The ODI contains 10 questions; each with 6 choices and each answer choice ranges from 0 to 5 points. The minimum score is 0 and maximum score is 50; the higher the score, the greater the disability indicated. Each question is 5 points each and is summed then divided by total possible point. Scores from each cohort will be compared.
Measured: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Pain - Visual Analog Scale (VAS)
VAS will be used to measure pain and discomfort. The scale is a horizontal line numbered 0 through 10 with "0" indicating no pain, "5" indicating moderate pain, and 10 indicating worst pain. Patients will be instructed to mark an "X" on the number corresponding to their level of back pain over the past week. They will also be asked to indicate their leg pain on a similar, but separate scale. Scores from each cohort will be compared.
Measured: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Quality of Life - EuroQol-5D
EuroQol-5D (EQ-5D) will be used to measure quality of life. The EQ-5D includes 5 multiple-choice questions with 3 choices each; each choice corresponding to a value of 1,2,or 3. Each value is entered into an algorithm that computes a score. The score can range from "1" = high quality of life" and "0" = poor quality of life. Scores will be compared between both cohorts.
Measured: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start10 Sep 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: The study was closed by the investigators due to lack of study population to enroll.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial with randomization ratio 1:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica J Bial, M.D., M.S., Principal investigator, Lahey ClinicRobert G Whitmore, M.D., Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543033
- Sponsor's protocol ID
- 2018-008
- Status last verified
- Jun 2020
- First submitted
- 11 Apr 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Pain and Functional Outcome Following Single Level Lumbar Nerve Decompression Surgery With or Without Preoperative Corticosteroid Epidural Injection
- ClinicalTrials.gov ID
- NCT03543033
- Acronym / sponsor ID
- 2018-008
- Conditions
- Lumbar Radiculopathy
- Keywords
- lumbar radiculopathy, corticosteroid epidural injection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was closed by the investigators due to lack of study population to enroll.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 1 Jun 2018 (actual)
- 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.
This randomized control trial will compare opioid use, pain, and functional outcomes following decompression surgery for single-level lumbar radiculopathy in patients who undergo placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to those who do not. The hypothesis of this study is that patients who receive the preoperative corticosteroid injection will have less reduced postoperative opioid use, as well as earlier mobilization, reduced length of stay, and faster return to work compared to control patients who do not receive the injection.
Detailed description
This is a randomized control study that will be completed within the Department of Neurosurgery at Lahey Hospital \& Medical Center. Patients will undergo their recommended surgery to treat single-level lumbar radiculopathy. Patients who are randomized to and consent to receiving a preoperative corticosteroid injection will report to clinic within 2 weeks prior to date of surgery to receive a corticosteroid injection. These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline. To assure the injection is epidural, we will be using loss of resistance technique under fluoroscopy and epidural placement will be confirmed with the live-image instillation in the AP and lateral positions of dye, with pattern confirming epidermal needle placement.
All patients will complete health outcome questionnaires (VAS, EQ-5D, ODI) at baseline (treatment cohort: prior to injection, control cohort: prior to spine surgery), 1 week post-op, 1 month post-op, and 3 months post-op. Patients will be instructed to bring all condition-related pain medication containers to each follow-up for research measuring purposes. Research personnel will record number of pills remaining in container, number of opioid prescription refills, and respective dates. Opioid usage for each subject will be tracked and converted to mg oral morphine equivalents using a standard table. Research personnel will capture additional clinic information such as length of stay, length of time before ambulation, and occurrence of any complications (i.e. DVT, infection). Opioid use, muscle relaxants, and other pain medication use will be followed for 3 months. At baseline and at each post-op follow up, patients will be asked to define their use of illicit drugs over the past 6 months (heroin, cocaine, marijuana, methamphetamine, other). Return to work date and work status will be captured out to 3 months. Patients will submit a health-cost diary at 1 week, 1 month, and 3 months, and this data will be combined with hospital-based cost information to generate a cost analysis. This diary will capture costs such as medication costs, copayments, travel, etc. Additionally, all patient surgery cancelations as well as reason for cancelation will be recorded. No additional medical testing will be required by the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial with randomization ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Corticosteroid injectionPatients will receive a corticosteroid epidural injection within 2 weeks of their scheduled lumbar surgery |
| Control | No intervention | –Patients will not receive a corticosteroid injection within 2 weeks of their scheduled lumbar surgery. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 30-75 years of age
- Patients diagnosed with diagnoses with single level unilateral lumbar radiculopathy
- Patients diagnosed with spinal stenosis or disc herniation
- Patients who have a history of > 6 weeks of at least 1 conservative treatment
- ASA < III
Key exclusion criteria (10 listed)
- Patients who have undergone previous lumbar spinal surgery at index level
- Patients diagnosed with spondylolisthesis at index level
- Patients currently taking anti-coagulant therapy
- Active treatment of major psychiatric condition such as major depression and/or anxiety disorder.
- Patients currently seeking or receiving workers compensation
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 |
|---|---|---|
| Corticosteroid injectionThese subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline | Drug | Treatment |
Primary outcome
Opioid Use - conversion to oral morphine equivalents using standard table
Time frame: Primary endpoint is 3 Months
Following spine surgery, # of prescription opioid pills used will be recorded and converted to oral morphine equivalents using a standard table. Information collected will include # of pills taken, # of prescription refills, and respective dates.
3 secondary outcomes
Disability - Oswestry Disability Index (ODI)
Time frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Pain - Visual Analog Scale (VAS)
Time frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Quality of Life - EuroQol-5D
Time frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Lumbar Radiculopathy
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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.
Erica J Bial, M.D., M.S. principal investigator
Lahey Clinic
Robert G Whitmore, M.D. principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid injection in people with Lumbar Radiculopathy, run by Lahey Clinic at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 18 Jun 2020. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Opioid Use - conversion to oral morphine equivalents using standard table (time frame: Primary endpoint is 3 Months). 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 18 Jun 2020.