Disc, HerniatedNCT03319875
Epiduroscopic Laser Discectomy Procedures
An observational study of Disc, Herniated, run by Sakarya University.
Trial summary
Epiduroscopy or spinal endoscopy is the imaging of the epidural space using a percutaneous and minimally invasive fiberoptic imaging device. The definitive diagnosis and treatment of chronic pain is increasingly prevalent with epiduroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disc, Herniated
- What is being tested?
- Epiduroscopic Laser Discectomy
- Type of treatment
- Medical device
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 25 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low back and / or leg pain attached to the Lomber disc hernia were included in the study.
Who may be able to join
- Patients with low back and / or leg pain for at least 3 months or more
- Patients who do not benefit from conservative treatment
- In patients who underwent Lumbar MRI examinations and had axial sheaths with a herniation of 3 mm or more
Who cannot join
- Patients with bleeding diathesis in preoperative laboratory tests
- Patients with any local or systemic infection
About this study
Official title: Evaluation of The Efficacy of Epiduroscopic Discectomy Procedures: A Retroscopic Study
Epiduroscopy or spinal endoscopy is the imaging of the epidural space using a percutaneous and minimally invasive fiberoptic imaging device. The definitive diagnosis and treatment of chronic pain is increasingly prevalent with epiduroscopy. Recently, as a result of these studies it has been reported that laser therapy with epiduroscopy applied discectomy during multiple lesions. Investigators aimed to retrospectively investigate the efficacy of epiduroscopic discectomy procedures performed at the Algology Clinic.
Read the detailed description
In this study, epiduroscopic discectomy procedures performed between January 2012 and July 2016 at the Algology Clinic of the Department of Anesthesiology and Reanimation, Sakarya University Training and Research Hospital, were examined retrospectively. After approval was received from the Sakarya University Faculty of Medicine's Ethics Committee, patient information was obtained from the KarMed (Kardelen Software, Turkey) hospital information system. Files were scanned from the hospital archive. The age, gender, weight, lumbar disc herniation level, preoperative and postoperative surgical history, amount of physiological saline used during the procedure and duration of the procedure, whether a lumbar epidural steroid (LES) was used during the procedure, the amount of epiduroscopic laser use during the procedure, and complications after the procedure were examined. The Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores were recorded preoperatively, as well as after 2 weeks and 2, 6, and 12 months postoperatively from the patient files.
The 2007 Number Cruncher Statistical System (NCSS, Kaysville, Utah, USA) program was used for statistical analysis. The Student t-test and Mann-Whitney U test were used for descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) in two groups, as well as the normal distribution of quantitative data. The Kruskal-Wallis test and Mann-Whitney U test were used in the comparison of three groups with no normal distribution. The Pearson Chi-square test was used to evaluate qualitative data, and Spearman's correlation analysis was used to evaluate intervariable relationships. The Friedman and Wilcoxon signed ranks tests were used in the evaluation of three or more follow-up parameters without normal distribution. Diagnostic screening tests (sensitivity, specificity) and receiver operating characteristic (ROC) analysis were used to determine the cutoff value for age. Significance was evaluated at the level of p < (0.01).
- Conditions
- Disc, Herniated
- Being tested
- Epiduroscopic Laser Discectomy
- Keywords
- Epiduroscopy, Discectomy, Holmium Yag laser, Lumbar disc herniation, Minimally invasive treatment
- 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.
Epiduroscopic Laser DiscectomyDevice
Caudal epidural space after passing through sacral hiatus
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Visual Analog Scale (VAS) scores were assessed retrospectively from hospital information system. Files have been scanned from the hospital archive.
VAS is a scale that assesses the intensity of pain during rest or activity of the patient. VAS score of 0 indicates no pain and a value of 10 indicates unbearable pain
Measured: One year
Oswestry Disability Index (ODI) scores were assessed retrospectively from hospital information system. Files have been scanned from the hospital archive.
ODI is an evaluation questionnaire that questions how much the pain affects the person's daily activities. It consists of 10 subgroups and each section contains 6 questions. Each episode has 0 points for the first option and 5 points for the sixth option. Subgroups are questioning pain severity, self-care, lifting-carrying, walking, sitting, standing, sleeping, sexual life, travel and social life. As the total score increases, the level of disability also increases.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Jan 2012
- Primary completion30 Jun 2016
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc, HerniatedStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serbülent Gökhan BEYAZ, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319875
- Sponsor's protocol ID
- Sakarya University Algology
- Status last verified
- Oct 2017
- First submitted
- 26 Sep 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Efficacy of Epiduroscopic Discectomy Procedures: A Retroscopic Study
- ClinicalTrials.gov ID
- NCT03319875
- Acronym / sponsor ID
- Sakarya University Algology
- Conditions
- Disc, Herniated
- Keywords
- Epiduroscopy, Discectomy, Holmium Yag laser, Lumbar disc herniation, Minimally invasive treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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.
Epiduroscopy or spinal endoscopy is the imaging of the epidural space using a percutaneous and minimally invasive fiberoptic imaging device. The definitive diagnosis and treatment of chronic pain is increasingly prevalent with epiduroscopy. Recently, as a result of these studies it has been reported that laser therapy with epiduroscopy applied discectomy during multiple lesions. Investigators aimed to retrospectively investigate the efficacy of epiduroscopic discectomy procedures performed at the Algology Clinic.
Detailed description
In this study, epiduroscopic discectomy procedures performed between January 2012 and July 2016 at the Algology Clinic of the Department of Anesthesiology and Reanimation, Sakarya University Training and Research Hospital, were examined retrospectively. After approval was received from the Sakarya University Faculty of Medicine's Ethics Committee, patient information was obtained from the KarMed (Kardelen Software, Turkey) hospital information system. Files were scanned from the hospital archive. The age, gender, weight, lumbar disc herniation level, preoperative and postoperative surgical history, amount of physiological saline used during the procedure and duration of the procedure, whether a lumbar epidural steroid (LES) was used during the procedure, the amount of epiduroscopic laser use during the procedure, and complications after the procedure were examined. The Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores were recorded preoperatively, as well as after 2 weeks and 2, 6, and 12 months postoperatively from the patient files.
The 2007 Number Cruncher Statistical System (NCSS, Kaysville, Utah, USA) program was used for statistical analysis. The Student t-test and Mann-Whitney U test were used for descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) in two groups, as well as the normal distribution of quantitative data. The Kruskal-Wallis test and Mann-Whitney U test were used in the comparison of three groups with no normal distribution. The Pearson Chi-square test was used to evaluate qualitative data, and Spearman's correlation analysis was used to evaluate intervariable relationships. The Friedman and Wilcoxon signed ranks tests were used in the evaluation of three or more follow-up parameters without normal distribution. Diagnostic screening tests (sensitivity, specificity) and receiver operating characteristic (ROC) analysis were used to determine the cutoff value for age. Significance was evaluated at the level of p < (0.01).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back and / or leg pain attached to the Lomber disc hernia were included in the study.
Key inclusion criteria (3 listed)
- Patients with low back and / or leg pain for at least 3 months or more
- Patients who do not benefit from conservative treatment
- In patients who underwent Lumbar MRI examinations and had axial sheaths with a herniation of 3 mm or more
Key exclusion criteria (2 listed)
- Patients with bleeding diathesis in preoperative laboratory tests
- Patients with any local or systemic infection
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 |
|---|---|---|
| Epiduroscopic Laser DiscectomyCaudal epidural space after passing through sacral hiatus | Device | – |
Primary outcome
Patients Visual Analog Scale (VAS) scores were assessed retrospectively from hospital information system. Files have been scanned from the hospital archive.
Time frame: One year
VAS is a scale that assesses the intensity of pain during rest or activity of the patient. VAS score of 0 indicates no pain and a value of 10 indicates unbearable pain
Oswestry Disability Index (ODI) scores were assessed retrospectively from hospital information system. Files have been scanned from the hospital archive.
Time frame: One year
ODI is an evaluation questionnaire that questions how much the pain affects the person's daily activities. It consists of 10 subgroups and each section contains 6 questions. Each episode has 0 points for the first option and 5 points for the sixth option. Subgroups are questioning pain severity, self-care, lifting-carrying, walking, sitting, standing, sleeping, sexual life, travel and social life. As the total score increases, the level of disability also increases.
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 24 Oct 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disc, Herniated, run by Sakarya University.
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 3 inclusion and 2 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 24 Oct 2017. 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 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?
Patients Visual Analog Scale (VAS) scores were assessed retrospectively from hospital information system. Files have been scanned from the hospital archive. (time frame: One year). The study lists 2 primary outcomes in all. 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 24 Oct 2017.