Disc HerniationPhase 4NCT01267825
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
A Phase 4 study testing CT-guided corticosteroid+ bupivicaine and Standard medical care in people with Disc Herniation and Lumbosacral Radiculopathy, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Disc Herniation, Lumbosacral Radiculopathy
- What is being tested?
- CT-guided corticosteroid+ bupivicaine and Standard medical care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to Aug 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults <60y
- < 1m of symptoms
- Symptoms consistent with herniated disc
- MRI demonstrates corresponding disc
- Back pain resulting in functional disability
Who cannot join
- Chronic pain
- Daily pain medication
- Frequent back pain
- On the job injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Trial of CT-guided Perineural Injection With a Corticosteroid Plus a Long Acting Local Anesthetic Versus Standard Medical Management in Patients With Acute Lumbar Radiculopathy and a Corresponding Disc Herniation
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.
- Conditions
- Disc Herniation, Lumbosacral Radiculopathy
- Being tested
- CT-guided corticosteroid+ bupivicaine, Standard medical care
- Keywords
- Disc herniation, Lumbosacral radiculopathy, Corticosteroids
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided corticosteroid+ bupivicaineDrug
CT-guided corticosteroid+ bupivicaine Also get standard medical care
Standard medical careDrug
Naproxen + Oxycodone/ Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| CT-guided intervention | Experimental | CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care Receives: Drug: CT-guided corticosteroid+ bupivicaine |
| Standard medical care | Active comparator | Not described Receives: Drug: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
Measured: Baseline and one week after emergency department discharge
Secondary outcomes (2)
Functional Disability Assessed Using Roland-Morris Scale
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, increasing functional disability.
Measured: 1 month
Adverse Events
Any adverse events since randomization. %s will be compared between groups
Measured: 1 week after discharge from emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study start1 Sep 2010
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Study terminated early due to low enrollment. No data collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disc HerniationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin W. Friedman, MD, Montefiore Medical Center
- Investigators
- Todd Miller, MD, Principal investigator, Montefiore Medical CenterBenjamin W. Friedman, MD, MS, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267825
- Sponsor's protocol ID
- 10-06-162
- Status last verified
- Aug 2018
- First submitted
- 25 Oct 2010
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of CT-guided Perineural Injection With a Corticosteroid Plus a Long Acting Local Anesthetic Versus Standard Medical Management in Patients With Acute Lumbar Radiculopathy and a Corresponding Disc Herniation
- ClinicalTrials.gov ID
- NCT01267825
- Acronym / sponsor ID
- 10-06-162
- Conditions
- Disc Herniation, Lumbosacral Radiculopathy
- Keywords
- Disc herniation, Lumbosacral radiculopathy, Corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to low enrollment. No data collected.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Posted 1 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-guided intervention | Experimental | Drug: CT-guided corticosteroid+ bupivicaineCT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care |
| Standard medical care | Active comparator | Drug: Standard medical care |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults <60y
- < 1m of symptoms
- Symptoms consistent with herniated disc
- MRI demonstrates corresponding disc
- Back pain resulting in functional disability
Key exclusion criteria (4 listed)
- Chronic pain
- Daily pain medication
- Frequent back pain
- On the job injury
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 |
|---|---|---|
| CT-guided corticosteroid+ bupivicaineCT-guided corticosteroid+ bupivicaine Also get standard medical care | Drug | CT-guided intervention |
| Standard medical careNaproxen + Oxycodone/ Acetaminophen | Drug | Standard medical care |
Primary outcome
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
Time frame: Baseline and one week after emergency department discharge
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
2 secondary outcomes
Functional Disability Assessed Using Roland-Morris Scale
Time frame: 1 month
Adverse Events
Time frame: 1 week after discharge from emergency department
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Todd Miller, MD principal investigator
Montefiore Medical Center
Benjamin W. Friedman, MD, MS principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CT-guided corticosteroid+ bupivicaine and Standard medical care in people with Disc Herniation and Lumbosacral Radiculopathy, run by Montefiore Medical Center 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 4 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: stopped early, as of the sponsor's last update on 31 Aug 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (time frame: Baseline and one week after emergency department discharge). 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 31 Aug 2018; AzTrials last refreshed its copy on 26 Oct 2026.