NCT05235308

Brief Summary

The primary aim of this exploratory study was to determine the demographic, clinical, and technical factors associated with treatment outcome, to create a better select treatment candidates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

28 days

First QC Date

February 2, 2022

Last Update Submit

August 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.

    baseline to 12 months post-procedure

Interventions

Percutaneous adhesiolysis is a minimally invasive technique which involves the use of a spring-wound catheter, ideally placed in the ventrolateral aspect of the epidural space for the lysis of adhesions.

Eligibility Criteria

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

Patients presenting with low back or leg pain who have not had positive responsive to the conservative treatments or procedures, such as epidural steroid injections.

You may qualify if:

  • patients in whom percutaneous epidural lysis of adhesions was performed

You may not qualify if:

  • nonadhesiolytic procedure
  • lack of follow-up
  • incomplete outcome data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

February 15, 2022

Primary Completion

March 15, 2022

Study Completion

April 15, 2022

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations