Lumbar Spine Disc Herniation Clinical Trial
— TDDOfficial title:
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series
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 disc protrusion (Lumboradicular Syndrome). Secondary objective will be to prove that the treatment Group will have less disability and better quality of life.
Status | Terminated |
Enrollment | 9 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Netherlands | Rijnland Ziekenhuis | Leiderdorp | |
Netherlands | Diakonessenhuis | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | NeuroTherm |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale | Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale. Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 months by a Anesthesiologist and the research nurse - both blinded for the performed procedure. | 3 months after treatment | No |
Secondary | MPQ-DLV (second pain measurement) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 | No | |
Secondary | Quebec Back Pain Disability Scale (disability) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 | No | |
Secondary | Rand-36 (quality of live) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 | No | |
Secondary | 7-point Likert scale (global perceived effect) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 | No |
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