Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Background: Breast pain, mastalgia or mastodynia, is recognized as an organic benign breast disease. Mastalgia may be bilateral, may be in only one breast or part of one breast, and may radiate to the axilla and down the medial aspect of the upper arm. This study aimed to evaluate the additional pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia to the routine regimen treatment of mastalgia tamoxifen 10 mg daily may improve breast pain severity and quality of life.

Method: Patients was randomly classified into two groups:Group A (n=13): they was received Tamoxifen 10 mg daily. Group B (n=13): they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. The following parameters were monitored: Primary outcome: VAS after injection and at interval two weeks, 1, 2 and 3 months after injection. Secondary outcome:1-Immediate complications for ex. Hematoma, neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).2-Need for analgesic intake was recorded.3-Side effect of Tamoxifen as nausea, vomiting, hot flashes and dizziness.4-Quality of life (The American Chronic Pain Association's Quality of life scale).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mansoura University
• Treatments: Analgesics; Tamoxifen

Criteria

Inclusion Criteria:

• complain from non-cyclic mastalgia aged from 20 to 60 with VAS > 4

Exclusion Criteria:

• cyclical mastalgia

• extra-mammary mastalgia

• patients refusal

• suspicion of malignancy

• acute inflammatory breast conditions

• presence of polycystic ovarian diseases or cervical hyperplasia

• pregnant patients and patients during lactation period

• coagulopathy disorder

• sepsis at the side of injection

• history of thromboembolic disease

• mental disorder and who was not willing or cannot finish the whole study

• disturbed anatomy (congenital, traumatic, and postsurgical), which increase the intervention difficulty.