NCT03715413

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

October 15, 2018

Last Update Submit

March 6, 2019

Conditions

Breast Fibroadenoma

Keywords

pulsed radiofrequency, non-cyclic mastalgia

Outcome Measures

Primary Outcomes (1)

  • VAS

    0=no pain, 10=worst pain

    3 months

Secondary Outcomes (2)

  • Immediate complications for ex

    one day

  • Side effect of Tamoxifen

    3 months

Study Arms (2)

Tamoxifen group

OTHER

they was received Tamoxifen 10 mg daily.

Drug: Tamoxifen

Tamoxifen and pulsed radiofrequency group

ACTIVE COMPARATOR

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.Drug: Tamoxifen

Interventions

pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.OTHER

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.

Tamoxifen and pulsed radiofrequency group
TamoxifenDRUG

received Tamoxifen 10 mg daily

Tamoxifen and pulsed radiofrequency groupTamoxifen group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yahay wahba

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Fibroadenoma

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 23, 2018

Study Start

August 15, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

EG(1)