Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast

NCT ID: NCT03888963

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2019-09-20

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRF

Group Type EXPERIMENTAL

PRF

Intervention Type PROCEDURE

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

Group Type SHAM_COMPARATOR

SHAM

Intervention Type PROCEDURE

patients will be subjected to the same procedure like PRF group without giving PRF

Interventions

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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

Intervention Type PROCEDURE

SHAM

patients will be subjected to the same procedure like PRF group without giving PRF

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Diab Fuad Hetta

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diab

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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diab hetta, MD

Role: CONTACT

+201091090009

Facility Contacts

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nuha awad

Role: primary

Other Identifiers

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SECI-IRB-IORG0009563-726

Identifier Type: -

Identifier Source: org_study_id

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