Visual Analogue Pain ScaleRFNaTDDNCT02025283
Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy
An observational study of Visual Analogue Pain Scale and Pain Measurement, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare early and long term efficacy of lumbar radiofrequency nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed previous conventional therapy. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Visual Analogue Pain Scale, Pain Measurement
- What is being tested?
- Group Decompression or Group Nucleoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 120 patients with lumbar radiculopathy undergoing nucleoplasty and targetted disc decompression in Algology Department of a University Hospital between 2010 and 2012 were retrospectively evaluated and complete data of only 73 patients were reached and they were included to the study
Who may be able to join
- patients having radicular pain with or without low back pain for at least 6 weeks inspite of conservative treatment who have unsequestrated, bulging, protruded or extruded hernia confirmed with MRI.
Who cannot join
- patients having a more than 50% loss in disc area, sequestrated disc, the presence of vertebra fracture or tumor, the patients having spinal stenosis or spondylolisthesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical School Algology Department
Ankara
About this study
Official title: The Comparison of the Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy: A Retrospective Review
The aim of this study is to compare early and long term efficacy of lumbar radiofrequency nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed previous conventional therapy. Medical records of 37 patients undergoing targeted disc decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Functional Rating Index, Backache index, Oswestry Lumbar Back Pain Disability Index, Rolland-Morris Lumbar Back Pain Questionnaire scales were used before treatment and 1,6,12 months after the procedure. North American Spine Society Satisfaction Scale was used at 12th month after the procedure.
- Conditions
- Visual Analogue Pain Scale, Pain Measurement
- Being tested
- Group Decompression or Group Nucleoplasty
- Keywords
- Intervertebral disc disease, Radiculopathy, Chronic pain, Thermocoagulation
- Medical subject headings
- Intervertebral disc disease, Radiculopathy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Decompression or Group NucleoplastyProcedure or surgery
Also called ArthroCare Spine, SpineCATH®
Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA]
| Study group | Role | What they receive |
|---|---|---|
| Group Decompression | Group Decompression: Patients assigned to Group Decompression. After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc. Then site verification was done again with water soluble contrast material under floroscopy guidance. Then flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) were advanced inside the trochar needle towards the disc and decompression was performed. After being sure of achieving sufficient decompression inside the disc, the decompression device were removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours. Receives: Procedure: Group Decompression or Group Nucleoplasty | |
| Group Nucleoplasty | Group Nucleoplasty : Patients assigned to Group Nucleoplasty. After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc. Then site verification was done again with water soluble contrast material under floroscopy guidance. Then radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA] were advanced inside the trochar needle towards the disc and nucleoplasty was performed. After being sure of achieving sufficient decompression inside the disc, the nucleoplasty probe was removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours. Receives: Procedure: Group Decompression or Group Nucleoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Visual Analogue Scale (VAS)
Measured: 12 months
Secondary outcomes (1)
More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Analogue Pain ScaleStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barıs Adaklı, Ankara University
- Investigators
- Barış Adaklı, Specialist, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025283
- Sponsor's protocol ID
- 10-402-13
- Acronym
- RFNaTDD
- Status last verified
- Dec 2013
- First submitted
- 24 Dec 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy: A Retrospective Review
- ClinicalTrials.gov ID
- NCT02025283
- Acronym / sponsor ID
- RFNaTDD / 10-402-13
- Conditions
- Visual Analogue Pain Scale, Pain Measurement
- Keywords
- Intervertebral disc disease, Radiculopathy, Chronic pain, Thermocoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Jan 2014 (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 aim of this study is to compare early and long term efficacy of lumbar radiofrequency nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed previous conventional therapy. Medical records of 37 patients undergoing targeted disc decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Functional Rating Index, Backache index, Oswestry Lumbar Back Pain Disability Index, Rolland-Morris Lumbar Back Pain Questionnaire scales were used before treatment and 1,6,12 months after the procedure. North American Spine Society Satisfaction Scale was used at 12th month after the procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Decompression | – | Procedure: Group Decompression or Group NucleoplastyGroup Decompression: Patients assigned to Group Decompression. After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc. Then site verification was done again with water soluble contrast material under floroscopy guidance. Then flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) were advanced inside the trochar needle towards the disc and decompression was performed. After being sure of achieving sufficient decompression inside the disc, the decompression device were removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours. |
| Group Nucleoplasty | – | Procedure: Group Decompression or Group NucleoplastyGroup Nucleoplasty : Patients assigned to Group Nucleoplasty. After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc. Then site verification was done again with water soluble contrast material under floroscopy guidance. Then radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA] were advanced inside the trochar needle towards the disc and nucleoplasty was performed. After being sure of achieving sufficient decompression inside the disc, the nucleoplasty probe was removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 120 patients with lumbar radiculopathy undergoing nucleoplasty and targetted disc decompression in Algology Department of a University Hospital between 2010 and 2012 were retrospectively evaluated and complete data of only 73 patients were reached and they were included to the study
Key inclusion criteria (1 listed)
- patients having radicular pain with or without low back pain for at least 6 weeks inspite of conservative treatment who have unsequestrated, bulging, protruded or extruded hernia confirmed with MRI.
Key exclusion criteria (1 listed)
- patients having a more than 50% loss in disc area, sequestrated disc, the presence of vertebra fracture or tumor, the patients having spinal stenosis or spondylolisthesis
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 |
|---|---|---|
| Group Decompression or Group NucleoplastyAlso: ArthroCare Spine, SpineCATH®Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA] | Procedure or surgery | Group Decompression, Group Nucleoplasty |
Primary outcome
Decrease in Visual Analogue Scale (VAS)
Time frame: 12 months
1 secondary outcome
More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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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.
Barış Adaklı, Specialist principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Analogue Pain Scale and Pain Measurement, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease in Visual Analogue Scale (VAS) (time frame: 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 1 Jan 2014.