Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs

Lumbar Spine Disc Herniation Clinical Trial

— TDD  

Official title:

Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01429363
• Other study ID #: LTC 760-220411
• Status: Terminated
• Phase: N/A
• First received: September 2, 2011
• Last updated: December 29, 2016
• Start date: August 2011
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Spine Disc Herniation

Intervention

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;

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Rijnland Ziekenhuis	Leiderdorp
Netherlands	Diakonessenhuis	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	NeuroTherm

Country where clinical trial is conducted

Netherlands, 

Outcome

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