Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management

October 14, 2020 updated by: Shereen Mamdouh, Assiut University
the role of transcranial magnetic stimulation over the primary motor cortex area on acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions.Transcranial direct current stimulation has been studied in patients with various disorders and multiple pain syndromes. There is also evidence that tDCS might be useful in postsurgical pain reduction.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 11715
        • South Egypt Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer

Exclusion Criteria:

  • patients with intracranial metallic devices or with pacemakers or any other device.
  • patients with Neurological or psychiatric disorders,
  • patients taking major centrally acting drugs (antiepileptics or antidepressants), -opioid dependence,
  • substance abuse,
  • severe cardiopulmonary, renal, hepatic diseases, and
  • those with extensive myocardial ischemia or unstable angina.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: real tDCS
motor cortex stimulation (2 mA, 20 min for 4 sessions)
Device: tDCS
motor cortex stimulation (2 mA, 20 min for 4 sessions)
SHAM_COMPARATOR: sham tDCS
motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge
Device: tDCS
motor cortex stimulation (2 mA, 20 min for 4 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total morphine comsuption
Time Frame: 48 hours
the total dose of morphine used as analgesic expressed in mg
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: baseline,at 2,4,6, 12, 24,36,48 hours
patient asked to describe this pain with scores ranging from 0 to10 (with 0 = no pain and 10 = the worst pain imaginable)
baseline,at 2,4,6, 12, 24,36,48 hours
Douleur Neuropathique 4 questions DN4
Time Frame: 1month, 3month, 6 month
the possibility of development of neuropathic pain will be assessed using DN4 scale
1month, 3month, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2017

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (ACTUAL)

February 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 405

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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