Clinical trial NCT02414698
Conditions: Lumbar Herniated Disc
Sponsor: Montefiore Medical Center
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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 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.

Arms: arm 1: Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System arm 2: Transforaminal Epidural Steroid Injections
Interventions: intervention 1: Percutaneous Hydrodiscectomy intervention 2: TESI
Intervention descriptions: intervention 1: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture. intervention 2: Transforaminal epidural steroid injections given in the lumbar spine.

Protocol documents: