Lumbar Herniated DiscPhase 4NCT02414698
Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy
A Phase 4 study testing Percutaneous Hydrodiscectomy and TESI in people with Lumbar Herniated Disc, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation with symptoms that persist following a treatment course of conservative management… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Herniated Disc
- What is being tested?
- Percutaneous Hydrodiscectomy and TESI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level subligamentous lumbar disc herniation with a size of up to 1/3 of the spinal canal sagittal diameter, with unilateral radicular pain attributed to nerve root impingement from lumbar disc material correlated with MRI or CT findings
- Axial MRI demonstrating unilateral focal contained disc herniation with single nerve contact
- Patient failed at least 3 weeks of conservative management within a 6 month period including anti-inflammatory medication and physical therapy
- Patient has not had previous epidural steroid injections at the affected lumbar level within 3 months of presenting for the study
- Patient is a candidate for transforaminal epidural steroid injections
- Positive Straight Leg Raising (SLR) test
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- Patient has a leg pain > back pain
- The subject is physically and mentally able to participate in the study
- Patient is willing and able to provide informed consent
- Patient is willing and able to comply with the study protocol
Who cannot join
- Patient has had surgery at the affected level
- Extruded or sequestered disc herniation
- Free fragment herniation
- Discogenic pain without nerve root compression
- Previous surgery at the involved lumbar level
- Segmental instability (motion on flexion/extension films)
Show all 15Show fewer
- Spondylolisthesis > Grade 2
- Severe central canal stenosis or bony impingement at the index level
- Significant loss of disc height (> 60%) compared with the adjacent higher level or disc height < 6mm at affected level
- Motor deficit (strength rating less than 4/5 in the lower extremity test)
- Positive Waddell test (> 3 of 5 tests)
- Active local or systemic infection
- Actively in litigation for pain symptoms
- Currently on Workman's Compensation
- Women who are pregnant
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: Single Center, Randomized PROspective Study Comparing Percutaneous HydroDiscectomy to Transforaminal Epidural Steroid Injections in the Treatment Of Radiculopathy Secondary to Lumbar Disc Herniation (PROPHESOR)
To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation with symptoms that persist following a treatment course of conservative management including physical therapy and anti-inflammatory medication.
Read the detailed description
Lumbar disc herniation is one of the leading causes of lower back pain and sciatica. If conservative management fails to relieve radiculopathy secondary to lumbar disc herniation, interventional treatments such as epidural steroid injections are indicated. Patients that do not have pain relief from transforaminal epidural steroid injections or over time relief is diminished, surgical intervention is typically recommended and microdiscectomy is the surgical intervention of choice. Over the years, a number of minimally invasive techniques for lumbar disc herniation have been introduced including percutaneous mechanical lumbar discectomy, including percutaneous hydrodiscectomy (HydroD).
The purpose of this study is to compare the outcomes of HydroD with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation that have failed a course of conservative management including anti-inflammatory medication and physical therapy. Patients will be randomized in a 1:1 ratio to Percutaneous Hydrodiscectomy or Transforaminal Epidural Steroid Injections.
Patients randomized to the TESI group that fail to have >50% relief of pain after two courses of TESI injections spaced two weeks apart within 2 months of the procedure, will be provided with the option to cross-over to the HydroD group after which they will follow the same follow-up visits. If after cross-over into the HydroD group they fail to have >50% relief of pain after the initial intervention within 2 months of the procedure, they will be referred for surgery and their participation in the study will end.
Patients randomized to the HydroD group that fail to have >50% relief of pain after the initial procedure, or within 2 months of the procedure, will be provided with the option to cross-over to the TESI group. If after cross-over to the TESI group they fail to have >50% relief of pain after two courses of TESI injections spaced two weeks apart within 2 months of the procedure, they will be referred for surgery and will no longer be followed in the study.
Patients will be followed at 1, and 4, and 2, 6, 12, and 24 months post-procedure. Outcomes assessments include NRS for pain, ODI, neurological and independent physician evaluations.
- Conditions
- Lumbar Herniated Disc
- Being tested
- Percutaneous Hydrodiscectomy, TESI
- 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.
Percutaneous HydrodiscectomyProcedure or surgery
The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
TESIDrug
Also called Transforaminal epidural steroid injections
Transforaminal epidural steroid injections given in the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Hydrodiscectomy | Active comparator | Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Receives: Procedure: Percutaneous Hydrodiscectomy |
| TESI | Active comparator | Transforaminal Epidural Steroid Injections Receives: Drug: TESI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain
Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.
Measured: 6 months
Secondary outcomes (2)
Change From Baseline Oswestry Disability Index (ODI)
Measured: 24 months
Change From Baseline ED-5Q Questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Integral investigator left study; could not continue recruiting.
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 Lumbar Herniated DiscStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sayed E Wahezi, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414698
- Sponsor's protocol ID
- 2014-3750
- Status last verified
- Feb 2020
- First submitted
- 8 Apr 2015
- Last updated
- 2 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized PROspective Study Comparing Percutaneous HydroDiscectomy to Transforaminal Epidural Steroid Injections in the Treatment Of Radiculopathy Secondary to Lumbar Disc Herniation (PROPHESOR)
- ClinicalTrials.gov ID
- NCT02414698
- Acronym / sponsor ID
- 2014-3750
- Conditions
- Lumbar Herniated Disc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Integral investigator left study; could not continue recruiting.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation with symptoms that persist following a treatment course of conservative management including physical therapy and anti-inflammatory medication.
Detailed description
Lumbar disc herniation is one of the leading causes of lower back pain and sciatica. If conservative management fails to relieve radiculopathy secondary to lumbar disc herniation, interventional treatments such as epidural steroid injections are indicated. Patients that do not have pain relief from transforaminal epidural steroid injections or over time relief is diminished, surgical intervention is typically recommended and microdiscectomy is the surgical intervention of choice. Over the years, a number of minimally invasive techniques for lumbar disc herniation have been introduced including percutaneous mechanical lumbar discectomy, including percutaneous hydrodiscectomy (HydroD).
The purpose of this study is to compare the outcomes of HydroD with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation that have failed a course of conservative management including anti-inflammatory medication and physical therapy. Patients will be randomized in a 1:1 ratio to Percutaneous Hydrodiscectomy or Transforaminal Epidural Steroid Injections.
Patients randomized to the TESI group that fail to have >50% relief of pain after two courses of TESI injections spaced two weeks apart within 2 months of the procedure, will be provided with the option to cross-over to the HydroD group after which they will follow the same follow-up visits. If after cross-over into the HydroD group they fail to have >50% relief of pain after the initial intervention within 2 months of the procedure, they will be referred for surgery and their participation in the study will end.
Patients randomized to the HydroD group that fail to have >50% relief of pain after the initial procedure, or within 2 months of the procedure, will be provided with the option to cross-over to the TESI group. If after cross-over to the TESI group they fail to have >50% relief of pain after two courses of TESI injections spaced two weeks apart within 2 months of the procedure, they will be referred for surgery and will no longer be followed in the study.
Patients will be followed at 1, and 4, and 2, 6, 12, and 24 months post-procedure. Outcomes assessments include NRS for pain, ODI, neurological and independent physician evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Hydrodiscectomy | Active comparator | Procedure: Percutaneous HydrodiscectomyPercutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System |
| TESI | Active comparator | Drug: TESITransforaminal Epidural Steroid Injections |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Single level subligamentous lumbar disc herniation with a size of up to 1/3 of the spinal canal sagittal diameter, with unilateral radicular pain attributed to nerve root impingement from lumbar disc material correlated with MRI or CT findings
- Axial MRI demonstrating unilateral focal contained disc herniation with single nerve contact
- Patient failed at least 3 weeks of conservative management within a 6 month period including anti-inflammatory medication and physical therapy
- Patient has not had previous epidural steroid injections at the affected lumbar level within 3 months of presenting for the study
- Patient is a candidate for transforaminal epidural steroid injections
Key exclusion criteria (15 listed)
- Patient has had surgery at the affected level
- Extruded or sequestered disc herniation
- Free fragment herniation
- Discogenic pain without nerve root compression
- Previous surgery at the involved lumbar level
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 |
|---|---|---|
| Percutaneous HydrodiscectomyThe HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture. | Procedure or surgery | Percutaneous Hydrodiscectomy |
| TESIAlso: Transforaminal epidural steroid injectionsTransforaminal epidural steroid injections given in the lumbar spine. | Drug | TESI |
Primary outcome
Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain
Time frame: 6 months
Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.
2 secondary outcomes
Change From Baseline Oswestry Disability Index (ODI)
Time frame: 24 months
Change From Baseline ED-5Q Questionnaire
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- 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.
Sayed E Wahezi, MD principal investigator
Montefiore Medical Center
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 Percutaneous Hydrodiscectomy and TESI in people with Lumbar Herniated Disc, 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 10 inclusion and 15 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 2 Mar 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.
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 12 Feb 2020). 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?
Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain (time frame: 6 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 2 Mar 2020.