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

The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03278184
Enrollment
75
Registered
2017-09-11
Start date
2017-10-01
Completion date
2019-11-01
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief summary

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

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.

Interventions

DEVICEtDCS 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.

DEVICEactive 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

DEVICEactive 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the total consumption of morphine administered by patients during the first two days postoperative48 hours postoperativethe investigator will calculate the amount of morphine used during the first two days postoperative.

Secondary

MeasureTime frameDescription
Pain severity assessment using visual analogue scale (VAS score from 0-10)30 minutes after every sessions and at the third daythe investigator will assess the pain at base line and at the end of sessions
HADS scorebefore surgery and at the third dayhospital anexiety and depression score

Countries

Egypt, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026