Postoperative PainNCT03448315
Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
A study testing tDCS in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2017to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- tDCS
- Keywords
- brain stimulation, tDCS, acute postoperative pain, chronic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
motor cortex stimulation (2 mA, 20 min for 4 sessions)
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | motor cortex stimulation (2 mA, 20 min for 4 sessions) Receives: Device: tDCS |
| sham tDCS | Sham comparator | motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine comsuption
the total dose of morphine used as analgesic expressed in mg
Measured: 48 hours
Secondary outcomes (2)
Visual analogue scale
patient asked to describe this pain with scores ranging from 0 to10 (with 0 = no pain and 10 = the worst pain imaginable)
Measured: baseline,at 2,4,6, 12, 24,36,48 hours
Douleur Neuropathique 4 questions DN4
the possibility of development of neuropathic pain will be assessed using DN4 scale
Measured: 1month, 3month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start2 Dec 2017
- Primary completion1 Apr 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448315
- Sponsor's protocol ID
- 405
- Status last verified
- Oct 2020
- First submitted
- 22 Feb 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
- ClinicalTrials.gov ID
- NCT03448315
- Acronym / sponsor ID
- 405
- Conditions
- Postoperative Pain
- Keywords
- brain stimulation, tDCS, acute postoperative pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: tDCSmotor cortex stimulation (2 mA, 20 min for 4 sessions) |
| sham tDCS | Sham comparator | Device: tDCSmotor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSmotor cortex stimulation (2 mA, 20 min for 4 sessions) | Device | real tDCS, sham tDCS |
Primary outcome
total morphine comsuption
Time frame: 48 hours
the total dose of morphine used as analgesic expressed in mg
2 secondary outcomes
Visual analogue scale
Time frame: baseline,at 2,4,6, 12, 24,36,48 hours
Douleur Neuropathique 4 questions DN4
Time frame: 1month, 3month, 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total morphine comsuption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.