- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03888963
Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
July 3, 2019 updated by: Diab Fuad Hetta, Assiut University
for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: diab hetta, MD
- Phone Number: +201091090009
- Email: diabhetta25@gmail.com
Study Locations
-
-
-
Assiut, Egypt, 71111
- Recruiting
- Diab
-
Contact:
- nuha awad
- Email: hetta@aun.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- patients with chronic mastalgia due to fibrocystic disease of the breast
- the pain duration maintained for more than 1 year
- the pain intensity is more than 5 on VAS pain score
Exclusion Criteria:
- coagulopathy
- infection at the site of the procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: SHAM
|
patients will be subjected to the same procedure like PRF group without giving PRF
|
Experimental: PRF
|
patients will receive pulsed radiofrequency, 4 cycles (each cycle, 2 minutes) on the thoracic paravertebral nerves number 2,3, and 4 under fluroscopic guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the changes in pain intensity measured by VAS pain score
Time Frame: patients will be evaluated at 3 months postoperatively
|
VAS pain score, is a scale for pain measurements scored from 0 to 10 in which 0 = no pain and 10 = the worst imaginable pain
|
patients will be evaluated at 3 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2019
Primary Completion (Anticipated)
August 20, 2019
Study Completion (Anticipated)
September 20, 2019
Study Registration Dates
First Submitted
March 22, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (Actual)
March 25, 2019
Study Record Updates
Last Update Posted (Actual)
July 8, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SECI-IRB-IORG0009563-726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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