Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03715413|
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : March 7, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Breast Fibroadenoma||Other: pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. Drug: Tamoxifen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia|
|Actual Study Start Date :||August 15, 2018|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
they was received Tamoxifen 10 mg daily.
received Tamoxifen 10 mg daily
Active Comparator: Tamoxifen and pulsed radiofrequency group
they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.
Other: pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.
Patients were lying prone. Firstly, T2, 3, 4 disc level was detected then the target 2nd, 3rd and 4th thoracic nerve roots were identified. After marking the entry points, adequate sterilization of the skin was achieved using bovidone iodine then the skin was anasthesied by 2 ml lidocaine 2% at each entry point. The Baileys radio frequency (RF) 22G, 10 cm, sharp needles with 10 mm active tip was introduced to face the 2nd, 3rd and 4th thoracic nerve roots.The PRF course was carried out at 42°C for 120 s twice at each level followed by injection of 1 ml lidocaine 2% and 1 ml dexamethasone 4 mg at each level.
received Tamoxifen 10 mg daily
- VAS [ Time Frame: 3 months ]0=no pain, 10=worst pain
- Immediate complications for ex [ Time Frame: one day ]Hematoma, neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).
- Side effect of Tamoxifen [ Time Frame: 3 months ]nausea, vomiting, hot flashes and dizziness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715413