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Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery

NCT ID: NCT03278184

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-11-01

Brief Summary

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The experience of pain derives from changes in brain excitability. Therefore, modulating the excitability of cortical areas involved in pain processing may become an attractive option in the context of multimodal analgesia during the postoperative period.

Detailed Description

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The combination of analgesic drugs acting on different mechanisms can potentiate the effects of analgesia. Moreover, the understanding of pain physiology at the molecular level supports the development of new specific drugs. Indeed, new neurophysiological models of pain processing by the brain are becoming exquisitely refined and are supported by electrophysiological and functional brain imaging studies. One of the interesting concepts that stemmed from these studies is the evidence that the experience of pain is reflected in the central nervous system by widespread activations and excitability changes within a network of interconnected cortical areas and subcortical structures. The network processing of noxious information and their limbic and emotional consequences has been termed the "pain matrix." The continuous observation of the activity and excitability changes that parallel the pain experience led to the development of a new therapeutic approach: the use of central nervous system stimulation techniques.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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tDCS sham motor cortex

25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.

Group Type SHAM_COMPARATOR

tDCS sham motor cortex

Intervention Type DEVICE

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.

Active motor cortex stimulation

25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.

Group Type ACTIVE_COMPARATOR

active motor cortex stimulation

Intervention Type DEVICE

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min

active prefrontal cortex stimulation

25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.

Group Type ACTIVE_COMPARATOR

active prefrontal cortex stimulation

Intervention Type DEVICE

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min

Interventions

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tDCS sham motor cortex

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.

Intervention Type DEVICE

active prefrontal cortex stimulation

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min

Intervention Type DEVICE

active motor cortex stimulation

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able to give informed consent to participate in the study.
* postoperative spine surgery patients(discectomy and/or laminectomy).
* American society of anesthesiology scores I to II patients.

Exclusion Criteria

* an adverse reaction to brain stimulation.
* a seizure
* an unexplained loss of consciousness
* a stroke
* serious head injury
* surgery to their head
* any brain related, neurological illnesses
* any illness that may have caused brain injury
* frequent or severe headaches
* metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding
* any implanted medical devices such as cardiac pacemaker's or medical pumps
* taking any analgesic medications in the past 24 hours
* pregnancy
* anyone in your family has epilepsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Saeid Metwaly Abouelyazid Elsawy

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saeid M Elsawy, MBBch

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Saeid Metwaly Elsawy

Asyut, , Egypt

Site Status

Saeid Elsawy

London, , United Kingdom

Site Status

Countries

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Egypt United Kingdom

Other Identifiers

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post tDCS

Identifier Type: -

Identifier Source: org_study_id