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Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NeuroTherm
Information provided by (Responsible Party):
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01429363
First received: September 2, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Lumbar Spine Disc Herniation
Procedure: Targeted disc decompression

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Quebec Back Pain Disability Scale (disability) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Rand-36 (quality of live) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ] [ Designated as safety issue: No ]
  • 7-point Likert scale (global perceived effect) [ Time Frame: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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;

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429363

Contacts
Contact: J.W Kallewaard, Drs. 0031(0)880058888 jkallewaard@rijnstate.nl
Contact: B. Baten, Drs. 0031(0)880056671 bbaten@rijnstate.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6800 TA
Contact: JW Kallewaard, MD    0031(88)0058888    jkallewaard@rijnstate.nl   
Rijnland Ziekenhuis Not yet recruiting
Leiderdorp, Netherlands, 2350 CC
Contact: R Sie, MD    0031(0)172467039    r.sie@rijnland.nl   
Principal Investigator: R Sie         
Diakonessenhuis Not yet recruiting
Utrecht, Netherlands, 3508 TG
Contact: F Willie, MD    0031(0)882505000    Fwille@diakhuis.nl   
Principal Investigator: F Willie         
Sponsors and Collaborators
Rijnstate Hospital
NeuroTherm
Investigators
Principal Investigator: JW Kallewaard, Drs. Rijnsate Hospital
  More Information

No publications provided

Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01429363     History of Changes
Other Study ID Numbers: LTC 760-220411
Study First Received: September 2, 2011
Last Updated: September 16, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
contained herniated lumbar discs
TDD
Case series
RCT

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014