Pain, PostoperativeNCT03278184
Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery
A study testing active prefrontal cortex stimulation and active motor cortex stimulation in people with Pain, Postoperative, run by Assiut University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- active prefrontal cortex stimulation and active motor cortex stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2017to 1 Nov 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- an adverse reaction to brain stimulation.
- a seizure
- an unexplained loss of consciousness
- a stroke
- serious head injury
- surgery to their head
Show all 14Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- tDCS sham motor cortex, active prefrontal cortex stimulation, active motor cortex stimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS sham motor cortexDevice
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 prefrontal cortex stimulationDevice
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
active motor cortex stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| tDCS sham motor cortex | Sham comparator | 25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device. Receives: Device: tDCS sham motor cortex |
| Active motor cortex stimulation | Active comparator | 25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device. Receives: Device: active motor cortex stimulation |
| active prefrontal cortex stimulation | Active comparator | 25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device. Receives: Device: active prefrontal cortex stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total consumption of morphine administered by patients during the first two days postoperative
the investigator will calculate the amount of morphine used during the first two days postoperative.
Measured: 48 hours postoperative
Secondary outcomes (2)
Pain severity assessment using visual analogue scale (VAS score from 0-10)
the investigator will assess the pain at base line and at the end of sessions
Measured: 30 minutes after every sessions and at the third day
HADS score
hospital anexiety and depression score
Measured: before surgery and at the third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Oct 2017
- Primary completion1 Apr 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeid Metwaly Abouelyazid Elsawy, Assiut University
- Investigators
- Saeid M Elsawy, MBBch, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278184
- Sponsor's protocol ID
- post tDCS
- Status last verified
- Dec 2021
- First submitted
- 5 Sep 2017
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study
- ClinicalTrials.gov ID
- NCT03278184
- Acronym / sponsor ID
- post tDCS
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 11 Sep 2017 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS sham motor cortex | Sham comparator | Device: tDCS sham motor cortex25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device. |
| Active motor cortex stimulation | Active comparator | Device: active motor cortex stimulation25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device. |
| active prefrontal cortex stimulation | Active comparator | Device: active prefrontal cortex stimulation25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- an adverse reaction to brain stimulation.
- a seizure
- an unexplained loss of consciousness
- a stroke
- serious head injury
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 |
|---|---|---|
| tDCS sham motor cortexthe 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. | Device | tDCS sham motor cortex |
| active prefrontal cortex stimulationthe 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 | Device | active prefrontal cortex stimulation |
| active motor cortex stimulationthe 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 | Device | Active motor cortex stimulation |
Primary outcome
the total consumption of morphine administered by patients during the first two days postoperative
Time frame: 48 hours postoperative
the investigator will calculate the amount of morphine used during the first two days postoperative.
2 secondary outcomes
Pain severity assessment using visual analogue scale (VAS score from 0-10)
Time frame: 30 minutes after every sessions and at the third day
HADS score
Time frame: before surgery and at the third day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Saeid M Elsawy, MBBch principal investigator
Assiut University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active prefrontal cortex stimulation and active motor cortex stimulation in people with Pain, Postoperative, run by Assiut University at 2 sites in 2 countries.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the total consumption of morphine administered by patients during the first two days postoperative (time frame: 48 hours postoperative). 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 14 Dec 2021.