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Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs (TDD)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429363
First Posted: September 7, 2011
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NeuroTherm
Information provided by (Responsible Party):
Rijnstate Hospital
September 2, 2011
September 7, 2011
December 30, 2016
August 2011
December 2016   (Final data collection date for primary outcome measure)
Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale [ Time Frame: 3 months after treatment ]
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.
Same as current
Complete list of historical versions of study NCT01429363 on ClinicalTrials.gov Archive Site
  • MPQ-DLV (second pain measurement) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ]
  • Quebec Back Pain Disability Scale (disability) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ]
  • Rand-36 (quality of live) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ]
  • 7-point Likert scale (global perceived effect) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ]
Same as current
Not Provided
Not Provided
 
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs
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.

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 diagnosis Lumboradicular syndrome the patient will first receive an transforaminal epidural injection at the site and level of the herniated disc, proven on MRI. Two weeks after the epidural injection the patient is evaluated. When the response is negative (a decrease less than 2.5 points on the 10 points VAS scale) TDD can be performed. Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 months after the study intervention. End point of this study is 3 months after TDD treatment. A positive response is defined as a minimal decrease of 2.5 points on the 10 points VAS scale compared to the VAS score at baseline.

A positive response in at least seven patients and acceptable side-effects and complications will lead to the start of a RCT.

If the response is positive < 7 out of 20 patients, the decision to proceed with a RCT following the prospective CS is made after evaluation of the CS by a team of experts. The results from this prospective study will be published.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lumbar Spine Disc Herniation
Procedure: Targeted disc decompression
The Targeted disc catheter is connected to Neurotherm TDD unit and heating protocol is started.In this heating protocol temperature gradually increases from 65C to 90C during a time period of 12 minutes;
Experimental: Targeted disc decompression
Intervention: Procedure: Targeted disc decompression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01429363
LTC 760-220411
No
Not Provided
Not Provided
Rijnstate Hospital
Rijnstate Hospital
NeuroTherm
Principal Investigator: JW Kallewaard, Drs. Rijnsate Hospital
Rijnstate Hospital
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP