Epiduroscopic Laser Discectomy Procedures

Disc, Herniated Clinical Trial

Official title:

Evaluation of The Efficacy of Epiduroscopic Discectomy Procedures: A Retroscopic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319875
• Other study ID #: Sakarya University Algology
• Status: Completed
• Phase: N/A
• First received: September 26, 2017
• Last updated: October 19, 2017
• Start date: January 1, 2012
• Est. completion date: June 25, 2017

Study information

• Verified date: October 2017
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: June 25, 2017
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with low back and / or leg pain for at least 3 months or more

2. Patients who do not benefit from conservative treatment

3. In patients who underwent Lumbar MRI examinations and had axial sheaths with a herniation of 3 mm or more

Exclusion Criteria:

1. Patients with bleeding diathesis in preoperative laboratory tests

2. Patients with any local or systemic infection

Related Conditions & MeSH terms

• Disc, Herniated
• Intervertebral Disc Displacement

Intervention

Device:
• Epiduroscopic Laser Discectomy
Caudal epidural space after passing through sacral hiatus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year
Primary	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.	One year