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NCT03715413
Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia
Phase 2 trial testing pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. in Breast Fibroadenoma in 64 participants. Completed in 1 December 2018.
1 December 2018
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 15 August 2018 |
| Primary completion | 1 December 2018 |
| Estimated completion | 1 December 2018 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.
- Tamoxifen — full drug profile →
Conditions studied
- Breast Fibroadenoma — all drugs for Breast Fibroadenoma →
Sponsor
Mansoura University
Who can join
Adults 20 to 60, female only, with Breast Fibroadenoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03715413 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 7 March 2019
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