Back to resultsPulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRF
SHAM
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- DiabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
PRF
SHAM
Arm Description
Outcomes
Primary Outcome Measures
the changes in pain intensity measured by VAS pain score
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03888963
Brief Title
Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
Official Title
for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
August 20, 2019 (Anticipated)
Study Completion Date
September 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRF
Arm Type
Experimental
Arm Title
SHAM
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
PRF
Intervention Description
patients will receive pulsed radiofrequency, 4 cycles (each cycle, 2 minutes) on the thoracic paravertebral nerves number 2,3, and 4 under fluroscopic guidance
Intervention Type
Procedure
Intervention Name(s)
SHAM
Intervention Description
patients will be subjected to the same procedure like PRF group without giving PRF
Primary Outcome Measure Information:
Title
the changes in pain intensity measured by VAS pain score
Description
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
Time Frame
patients will be evaluated at 3 months postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
diab hetta, MD
Phone
+201091090009
Email
diabhetta25@gmail.com
Facility Information:
Facility Name
Diab
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
nuha awad
Email
hetta@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
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