NCT03319875

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

4.5 years

First QC Date

September 26, 2017

Last Update Submit

October 19, 2017

Conditions

Keywords

EpiduroscopyDiscectomyHolmium Yag laserLumbar disc herniationMinimally invasive treatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Caudal epidural space after passing through sacral hiatus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with low back and / or leg pain attached to the Lomber disc hernia were included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with bleeding diathesis in preoperative laboratory tests
  • Patients with any local or systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 24, 2017

Study Start

January 1, 2012

Primary Completion

June 30, 2016

Study Completion

June 25, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share