Lumbar Spine Disc HerniationTDDNCT01429363
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs
A study testing Targeted disc decompression in people with Lumbar Spine Disc Herniation, run by Rijnstate Hospital at 3 sites in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spine Disc Herniation
- What is being tested?
- Targeted disc decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesNetherlands
- Study dates
- Aug 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem, Gelderland, 6800 TA
Rijnland Ziekenhuis
Leiderdorp, 2350 CC
Diakonessenhuis
Utrecht, Utrecht, 3508 TG
About this study
Official title: Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series
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.
Read the 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.
- Conditions
- Lumbar Spine Disc Herniation
- Being tested
- Targeted disc decompression
- Keywords
- contained herniated lumbar discs, TDD, Case series, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted disc decompressionProcedure or surgery
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;
| Study group | Role | What they receive |
|---|---|---|
| Targeted disc decompression | Experimental | Not described Receives: Procedure: Targeted disc decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after treatment
Secondary outcomes (4)
MPQ-DLV (second pain measurement)
Measured: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
Quebec Back Pain Disability Scale (disability)
Measured: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
Rand-36 (quality of live)
Measured: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
7-point Likert scale (global perceived effect)
Measured: Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroTherm
- Responsible party
- Sponsor
- Investigators
- JW Kallewaard, Drs., Principal investigator, Rijnsate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429363
- Sponsor's protocol ID
- LTC 760-220411
- Acronym
- TDD
- Status last verified
- Dec 2016
- First submitted
- 2 Sep 2011
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs. A Prospective Clinical Series
- ClinicalTrials.gov ID
- NCT01429363
- Acronym / sponsor ID
- TDD / LTC 760-220411
- Conditions
- Lumbar Spine Disc Herniation
- Keywords
- contained herniated lumbar discs, TDD, Case series, RCT
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- NeuroTherm
- Study start
- Aug 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted disc decompression | Experimental | Procedure: Targeted disc decompression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted disc decompressionThe 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; | Procedure or surgery | Targeted disc decompression |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JW Kallewaard, Drs. principal investigator
Rijnsate Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted disc decompression in people with Lumbar Spine Disc Herniation, run by Rijnstate Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.