Herniated DiscNCT00300898
Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation
A study testing Nucleoplasty, Percutaneous decompression and Intervertebral electrothermal disc decompression (IDET) in people with Herniated Disc, run by The Cleveland Clinic.
Trial summary
The purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Herniated Disc
- What is being tested?
- Nucleoplasty, Percutaneous decompression and Intervertebral electrothermal disc decompression (IDET)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Aug 2007
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months
- Leg pain must be greater than back pain
- Contained disc herniation as evidenced by MRI
- No evidence of psychological issues by exam or history
Who cannot join
- A score of greater than 10 on Beck Depression Inventory (BDI)
- Patients with pending workers compensation claim or litigation
- Pregnancy
- Tumor
- Systemic infection or localized infection at the anticipated entry needle site
- Traumatic spinal fracture
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- History of coagulopathy
- Unexplained bleeding
- Progressive neurological deficits
- History of opioid abuse or patients currently on long acting opioids
- Patients presenting with moderate or severe lumbar central or lateral canal stenosis, free disc fragments or degenerative disc disease as described on MRI
About this study
Official title: Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy (Dekompressor) vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation: A Prospective Randomized Controlled Study
The purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.
Read the detailed description
Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back pain. Over the last decade, there is a tendency to shift from surgical treatment of the intervertebral disc including laminectomy/discectomy to an excess of nonoperative management. Three techniques introduced recently are used as minimally invasive treatments for decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation® radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter disc decompression uses heat from a resistive coil positioned in the area of disc herniation while Dekompressor® uses volume reduction to decrease an intradiscal pressure.
This is a comparison study which investigates if intervertebral electrothermal disc decompression produces better pain relief measured on VAS scale, improvement in functional capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled study. Patients will be randomized into four treatment groups in equal numbers. The first group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc decompression, the third will receive thermal treatment using decompression catheter (Achutherm TM) and the forth will be the control group. The control group will be treated conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.
Patients will be followed and assessed at one, three, six, nine and twelve months following the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and return to work evaluation.
- Conditions
- Herniated Disc
- Being tested
- Nucleoplasty, Percutaneous decompression, Intervertebral electrothermal disc decompression (IDET), Conservative treatment
- Keywords
- contained lumbar herniated disc, nucleoplasty, percutaneous decompression, Dekompressor, intervertebral electrothermal disc decompression, IDET
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NucleoplastyProcedure or surgery
Percutaneous decompressionProcedure or surgery
Intervertebral electrothermal disc decompression (IDET)Procedure or surgery
Conservative treatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nucleoplasty | Active comparator | Procedure/Surgery: Nucleoplasty Receives: Procedure: Nucleoplasty |
| Percutaneous decompression | Active comparator | Procedure/Surgery: Percutaneous decompression Receives: Procedure: Percutaneous decompression |
| Electrothermal disc decompression (IDET) | Active comparator | Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET) Receives: Procedure: Intervertebral electrothermal disc decompression (IDET) |
| Behavioral:Conservative treatment | Experimental | Conservative treatment with oral medications, physical therapy, epidural steroid injections Receives: Behavioral: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months
Measured: baseline 1, 3, 6, 9, 12 months
Secondary outcomes (5)
Oswestry results
Disability Index
Measured: baseline 1, 3, 6, 9, 12 months
Quality of Life SF-36
SF-36 score at baseline 1, 3, 6, 9, 12 months
Measured: baseline 1, 3, 6, 9, 12 months
Return to work evaluation
Return to work evaluation
Measured: 1 month
Depression score
Beck Depression Inventory score at pre-treatment visit
Measured: BASELINE
Opioid use
Opioid use
Measured: 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: Unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonardo Kapural, MD, OhD, Principal investigator, Cleveland Clinic Foundation, Pain Management Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300898
- Sponsor's protocol ID
- IRB 8006
- Status last verified
- May 2022
- First submitted
- 8 Mar 2006
- Last updated
- 3 May 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy (Dekompressor) vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00300898
- Acronym / sponsor ID
- IRB 8006
- Conditions
- Herniated Disc
- Keywords
- contained lumbar herniated disc, nucleoplasty, percutaneous decompression, Dekompressor, intervertebral electrothermal disc decompression, IDET
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2006 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 10 Mar 2006 (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 purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.
Detailed description
Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back pain. Over the last decade, there is a tendency to shift from surgical treatment of the intervertebral disc including laminectomy/discectomy to an excess of nonoperative management. Three techniques introduced recently are used as minimally invasive treatments for decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation® radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter disc decompression uses heat from a resistive coil positioned in the area of disc herniation while Dekompressor® uses volume reduction to decrease an intradiscal pressure.
This is a comparison study which investigates if intervertebral electrothermal disc decompression produces better pain relief measured on VAS scale, improvement in functional capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled study. Patients will be randomized into four treatment groups in equal numbers. The first group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc decompression, the third will receive thermal treatment using decompression catheter (Achutherm TM) and the forth will be the control group. The control group will be treated conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.
Patients will be followed and assessed at one, three, six, nine and twelve months following the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and return to work evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nucleoplasty | Active comparator | Procedure: NucleoplastyProcedure/Surgery: Nucleoplasty |
| Percutaneous decompression | Active comparator | Procedure: Percutaneous decompressionProcedure/Surgery: Percutaneous decompression |
| Electrothermal disc decompression (IDET) | Active comparator | Procedure: Intervertebral electrothermal disc decompression (IDET)Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET) |
| Behavioral:Conservative treatment | Experimental | Behavioral: Conservative treatmentConservative treatment with oral medications, physical therapy, epidural steroid injections |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months
- Leg pain must be greater than back pain
- Contained disc herniation as evidenced by MRI
- No evidence of psychological issues by exam or history
Key exclusion criteria (11 listed)
- A score of greater than 10 on Beck Depression Inventory (BDI)
- Patients with pending workers compensation claim or litigation
- Pregnancy
- Tumor
- Systemic infection or localized infection at the anticipated entry needle site
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 |
|---|---|---|
| Nucleoplasty | Procedure or surgery | Nucleoplasty |
| Percutaneous decompression | Procedure or surgery | Percutaneous decompression |
| Intervertebral electrothermal disc decompression (IDET) | Procedure or surgery | Electrothermal disc decompression (IDET) |
| Conservative treatment | Behavioural | Behavioral:Conservative treatment |
Primary outcome
VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months
Time frame: baseline 1, 3, 6, 9, 12 months
5 secondary outcomes
Oswestry results
Time frame: baseline 1, 3, 6, 9, 12 months
Quality of Life SF-36
Time frame: baseline 1, 3, 6, 9, 12 months
Return to work evaluation
Time frame: 1 month
Depression score
Time frame: BASELINE
Opioid use
Time frame: 1, 3, 6, 9, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
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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.
Leonardo Kapural, MD, OhD principal investigator
Cleveland Clinic Foundation, Pain Management Department
Questions about this trial
What is this clinical trial studying?
A study testing Nucleoplasty, Percutaneous decompression and Intervertebral electrothermal disc decompression (IDET) in people with Herniated Disc, run by The Cleveland Clinic.
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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months (time frame: baseline 1, 3, 6, 9, 12 months). 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 3 May 2022.