Status:
TERMINATED
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
NeuroTherm
Conditions:
Lumbar Spine Disc Herniation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The prospective Clinical Series (CS) aims to prove the hypothesis that Targeted Disc Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary to a contained focal d...
Detailed Description
The study will start with a prospective clinical series (CS) in which 20 patients after careful selection will be treated with TDD, followed by a standardized rehabilitation program. After the diagnos...
Eligibility Criteria
Inclusion
- Mono radicular leg pain for at least 6 weeks as a result from a lumbar contained herniated disc. Leg pain must be of greater impact then concomitant back-pain
- Failing conservative treatment; analgesics and/or physical therapy ( WHO 1-3). Failing means persisting pain leading to problems with daily activities.
- MRI: must be performed \< 6 weeks before start treatment. On MRI signs of contained herniated disc, maximum 33% obliteration of the spinal channel. No signs of other significant spine pathology (see exclusion criteria).
- Negative response to a transforaminal epidural injection. Injection must be performed \< 6 weeks before start treatment but least 2 weeks before start treatment
- Neurological investigation by neurologist. Symptoms should be clinical related to the disc herniation level.
- Age \>18 and \< 50 years
- Mean pain on visual analogue scale (VAS) \>50 mm (0 -100)
Exclusion
- Herniated disc with more then 33% obliteration of the spinal channel.
- Annulus rupture with sequestrated herniated disc.
- Pain on VAS below 50 mm
- Pain existing longer then one year
- Less then 50% preserved disc height
- Conflict with social security/insurance
- Major motor impairment as a result of the herniation, paresis gr 3 MRC or more
- Other degenerative causes of nerve root compression; ligament flavum or facet joint hypertrophy, degenerative spinal channel stenosis, loss of lumbar kyphosis, discopathy with signs of Schmorls' nodules and loss of nucleus pulposus signal. Other causes of radicular syndrome such as cancer, radiculitis or neural degeneration.
- Spinal instability (spondylolisthesis, spinal fracture or tumor)
- History of back surgery, chemonucleolysis or other intra discal procedures
- Coagulopathies or oral anti-coagula therapy
- Infection
- Pregnancy
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01429363
Start Date
August 1 2011
End Date
December 1 2016
Last Update
December 30 2016
Active Locations (3)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
2
Diakonessenhuis
Utrecht, Utrecht, Netherlands, 3508 TG
3
Rijnland Ziekenhuis
Leiderdorp, Netherlands, 2350 CC