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

Primary Purpose

Lumbar Spine Disc Herniation

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Targeted disc decompression
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Disc Herniation focused on measuring contained herniated lumbar discs, TDD, Case series, RCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital
  • Rijnland Ziekenhuis
  • Diakonessenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted disc decompression

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MPQ-DLV (second pain measurement)
Quebec Back Pain Disability Scale (disability)
Rand-36 (quality of live)
7-point Likert scale (global perceived effect)

Full Information

First Posted
September 2, 2011
Last Updated
December 29, 2016
Sponsor
Rijnstate Hospital
Collaborators
NeuroTherm
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1. Study Identification

Unique Protocol Identification Number
NCT01429363
Brief Title
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs
Acronym
TDD
Official Title
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
NeuroTherm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 disc protrusion (Lumboradicular Syndrome). Secondary objective will be to prove that the treatment Group will have less disability and better quality of life.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disc Herniation
Keywords
contained herniated lumbar discs, TDD, Case series, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted disc decompression
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Targeted disc decompression
Intervention Description
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 Outcome Measure Information:
Title
Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale
Description
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.
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
MPQ-DLV (second pain measurement)
Time Frame
Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
Title
Quebec Back Pain Disability Scale (disability)
Time Frame
Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
Title
Rand-36 (quality of live)
Time Frame
Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
Title
7-point Likert scale (global perceived effect)
Time Frame
Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JW Kallewaard, Drs.
Organizational Affiliation
Rijnsate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800 TA
Country
Netherlands
Facility Name
Rijnland Ziekenhuis
City
Leiderdorp
ZIP/Postal Code
2350 CC
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
ZIP/Postal Code
3508 TG
Country
Netherlands

12. IPD Sharing Statement

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Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs

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