Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs

NCT01429363 | Terminated

• 1 other identifier: LTC 760-220411
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Lumbar Spine Disc Herniation

Keywords

contained herniated lumbar discs; TDD; Case series; RCT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• MPQ-DLV (second pain measurement)

  Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24

• Quebec Back Pain Disability Scale (disability)

  Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24

• Rand-36 (quality of live)

  Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24

• 7-point Likert scale (global perceived effect)

  Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24

Study Arms (1)

Targeted disc decompression

EXPERIMENTAL

Procedure: Targeted disc decompression

Interventions

Targeted disc decompression PROCEDURE

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;

Targeted disc decompression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• NeuroTherm: collaborator

Study Sites (3)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Diakonessenhuis

Utrecht, Utrecht, 3508 TG, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, 2350 CC, Netherlands

Location

Study Officials

• JW Kallewaard, Drs.

  Rijnsate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 7, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

NL (3)