Percutaneous Hydrodiscectomy Compared to TESI for Radiculopathy
Purpose and Objective
The purpose of this clinical trial is to compare the outcomes of percutaneous lumbar hydrodiscectomy with 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. 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 transforaminal epidural steroid injections spaced two weeks apart within 2 months of the procedure, will be provided with the option to cross-over to the hydrodiscectomy group, after which they will follow the same follow-up visits.
If after cross-over into the hydrodiscectomy 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 will be followed at 1, and 4, and 2, 6, 12, and 24 months post-procedure.
Outcomes assessments include numeric rating scale for pain, Oswestry Disability Index, and neurological and independent physician evaluations.
Condition: Lumbar Herniated Disc
Intervention: Percutaneous yydrodiscectomy
Clinical Trial Sponsor
This clinical trial is sponsored by Montefiore Medical Center.
Recruiting Location (United States)
Montefiore Medical Center
Bronx, New York, United States, 10467
Contact: Sayed E Wahezi, MD 718-920-7246
Eligibility, Inclusion and Exclusion Criteria
- 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
- 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
- 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)
- 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
* Additional inclusion/exclusion criteria apply. Please consult with your physician to review the complete eligibility criteria.