Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
1 other identifier
interventional
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Mar 2019
Shorter than P25 for not_applicable chronic-pain
1 active site
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
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedJuly 8, 2019
July 1, 2019
5 months
March 22, 2019
July 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
patients will be evaluated at 3 months postoperatively
Study Arms (2)
PRF
EXPERIMENTALSHAM
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- coagulopathy
- infection at the site of the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diab
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
March 22, 2019
First Posted
March 25, 2019
Study Start
March 28, 2019
Primary Completion
August 20, 2019
Study Completion
September 20, 2019
Last Updated
July 8, 2019
Record last verified: 2019-07