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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
Sponsor:
Information provided by (Responsible Party):
Nevert Adel, Mansoura University

Brief 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).


Condition or disease Intervention/treatment Phase
Breast Fibroadenoma Other: pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. Drug: Tamoxifen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Tamoxifen group
they was received Tamoxifen 10 mg daily.
Drug: Tamoxifen
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.

Drug: Tamoxifen
received Tamoxifen 10 mg daily




Primary Outcome Measures :
  1. VAS [ Time Frame: 3 months ]
    0=no pain, 10=worst pain


Secondary Outcome Measures :
  1. Immediate complications for ex [ Time Frame: one day ]
    Hematoma, neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).

  2. Side effect of Tamoxifen [ Time Frame: 3 months ]
    nausea, vomiting, hot flashes and dizziness.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Egypt
Yahay wahba
Mansourah, Egypt
Sponsors and Collaborators
Mansoura University

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Responsible Party: Nevert Adel, lecturer of anesthesia, Mansoura University
ClinicalTrials.gov Identifier: NCT03715413    
Other Study ID Numbers: MansouraU3
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nevert Adel, Mansoura University:
pulsed radiofrequency, non-cyclic mastalgia
Additional relevant MeSH terms:
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Fibroadenoma
Mastodynia
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Pain
Neurologic Manifestations
Signs and Symptoms
Tamoxifen
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents