Post-Operative PainNCT01861587
Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
A study testing tDCS in people with Post-Operative Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Operative Pain
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years-75 years of age
- surgery at Medical University of South Carolina
- at least 2 days of post-operative stay
Who cannot join
- history of seizures or epilepsy
- family history of seizures
- taking any medications shown to lower seizure threshold
- metal implants above the waist
- pregnant
- brain tumors or lesions
- pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Stimulation Laboratory, Institute of Psychiatry
Charleston, South Carolina, 29425
About this study
The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.
Read the detailed description
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.
- Conditions
- Post-Operative Pain
- Being tested
- tDCS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
20 minutes of either real or sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS:Active Comparator | Experimental | For Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system). Receives: Device: tDCS |
| Sham tDCS: Sham Comparator | Experimental | For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Controlled Analgesia (PCA) Hydromorphone Usage
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
Measured: Participants were followed for the duration of hospital stay, an average of 48 hours.
Average Pain at Least
To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Measured: Baseline and Discharge
Average Pain at Worst
To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Measured: Baseline Only
Average Pain
To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Measured: Baseline Only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startOct 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Operative PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Borckardt, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861587
- Sponsor's protocol ID
- HR18682
- Status last verified
- Jul 2018
- First submitted
- 26 Apr 2012
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
- ClinicalTrials.gov ID
- NCT01861587
- Acronym / sponsor ID
- HR18682
- Conditions
- Post-Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 10 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.
Detailed description
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS:Active Comparator | Experimental | Device: tDCSFor Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system). |
| Sham tDCS: Sham Comparator | Experimental | Device: tDCSFor sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years-75 years of age
- surgery at Medical University of South Carolina
- at least 2 days of post-operative stay
Key exclusion criteria (7 listed)
- history of seizures or epilepsy
- family history of seizures
- taking any medications shown to lower seizure threshold
- metal implants above the waist
- pregnant
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 |
|---|---|---|
| tDCS20 minutes of either real or sham stimulation | Device | Real tDCS:Active Comparator, Sham tDCS: Sham Comparator |
Primary outcome
Patient Controlled Analgesia (PCA) Hydromorphone Usage
Time frame: Participants were followed for the duration of hospital stay, an average of 48 hours.
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
Average Pain at Least
Time frame: Baseline and Discharge
To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Average Pain at Worst
Time frame: Baseline Only
To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Average Pain
Time frame: Baseline Only
To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Borckardt, Ph.D. principal investigator
Medical University of South Carolina
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 Post-Operative Pain, run by Medical University of South Carolina at 1 site in United States.
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 7 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 7 Aug 2018. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Controlled Analgesia (PCA) Hydromorphone Usage (time frame: Participants were followed for the duration of hospital stay, an average of 48 hours.). The study lists 4 primary outcomes in all. 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 7 Aug 2018.