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

A

Assiut University

Status

Completed

Conditions

Pain, Postoperative

Treatments

Device: tDCS sham motor cortex
Device: active motor cortex stimulation
Device: active prefrontal cortex stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03278184
post tDCS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: the participant who has any history of:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

75 participants in 3 patient groups

tDCS sham motor cortex
Sham Comparator group
Description:
25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.
Treatment:
Device: tDCS sham motor cortex
Active motor cortex stimulation
Active Comparator group
Description:
25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.
Treatment:
Device: active motor cortex stimulation
active prefrontal cortex stimulation
Active Comparator group
Description:
25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.
Treatment:
Device: active prefrontal cortex stimulation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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