Clinical trial · Interventional
Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Fibroadenoma | Breast Fibroadenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. | Other | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Tamoxifen group
- description
- they was received Tamoxifen 10 mg daily.
- interventionNames
- Drug: Tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- Tamoxifen and pulsed radiofrequency group
- description
- they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.
- interventionNames
- Other: pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- VAS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available