Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast

Chronic Pain Clinical Trial

Official title:

for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888963
• Other study ID #: SECI-IRB-IORG0009563-726
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: diab hetta, MD
• Phone: +201091090009
• Email: diabhetta25[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases
• Chronic Pain
• Cystic Fibrosis

Intervention

Procedure:
• 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
• SHAM
patients will be subjected to the same procedure like PRF group without giving PRF

Locations

Country	Name	City	State
Egypt	Diab	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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