Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs (TDD)
|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.|
|ClinicalTrials.gov Identifier: NCT01429363|
Recruitment Status : Terminated
First Posted : September 7, 2011
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spine Disc Herniation||Procedure: Targeted disc decompression||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
|Experimental: Targeted disc decompression||
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;
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429363
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Leiderdorp, Netherlands, 2350 CC|
|Utrecht, Netherlands, 3508 TG|
|Principal Investigator:||JW Kallewaard, Drs.||Rijnsate Hospital|