Pain, ChronicNCT05235308

Predictive Factors on the Results of Epidural Adhesiolysis in Patient With Chronic Spinal Pain

An observational study of Pain, Chronic, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Chronic
What is being tested?: Percutaneous adhesiolysis
Type of treatment: Surgery or procedure
How many people: 193 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Feb 2022to 15 Apr 2022
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 presenting with low back or leg pain who have not had positive responsive to the conservative treatments or procedures, such as epidural steroid injections.

Who may be able to join

patients in whom percutaneous epidural lysis of adhesions was performed

Who cannot join

nonadhesiolytic procedure
lack of follow-up
incomplete outcome data

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110

Other trials in Turkey (Türkiye)

About this study

Official title: Predictive Factors on the Results of Percutaneous Epidural Adhesiolysis in Patient With Chronic Spinal Pain

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.

Conditions: Pain, Chronic
Being tested: Percutaneous adhesiolysis
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous adhesiolysisProcedure or surgery
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline to 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202215 Apr 2022

First posted11 Feb 2022
Study start15 Feb 2022
Primary completion15 Mar 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, ChronicStudies 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: Cohort
Time perspective: Retrospective
Enrolment: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05235308
Sponsor's protocol ID: 127/22
Status last verified: Aug 2023
First submitted: 2 Feb 2022
Last updated: 15 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictive Factors on the Results of Percutaneous Epidural Adhesiolysis in Patient With Chronic Spinal Pain
ClinicalTrials.gov ID: NCT05235308
Acronym / sponsor ID: 127/22
Conditions: Pain, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: Diskapi Teaching and Research HospitalUniversity, hospital or other
Study start: 15 Feb 2022 (actual)
Primary completion: 15 Mar 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 11 Feb 2022 (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.

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.

Study design

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

Key inclusion criteria (1 listed)

patients in whom percutaneous epidural lysis of adhesions was performed

Key exclusion criteria (3 listed)

nonadhesiolytic procedure
lack of follow-up
incomplete outcome data

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
Percutaneous adhesiolysisPercutaneous 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.	Procedure or surgery	–

Primary outcome

pain intensity
Time frame: baseline to 12 months post-procedure
The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.

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 15 Aug 2023.
Individual participant dataSharing planned: No

Related trials for Pain, Chronic

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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.

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 Pain, Chronic, run by Diskapi Teaching and Research Hospital 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 3 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 15 Aug 2023. 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?

pain intensity (time frame: baseline to 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05235308.

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 15 Aug 2023.