Pain
Conditions
Keywords
Healthy Adults, Pain Perception
Brief summary
The purpose of this study is to determine whether a new medical technology can temporarily alter pain perception. The new technology is called Transcranial direct current stimulation (tDCS).
Detailed description
Healthy subjects underwent thermal pain tolerance testing pre- and post intervention. The intervention includes either anodal, cathodal, or sham tDCS for 20 minutes during a pain cognitive intervention \[either brief cognitive intervention (BCI) or general pain education\]. The tDCS brand was the Phoresor-II Auto (Model PM850, Iomed, Salt Lake City Utah, USA) and the current was set to 2.0mA. Electrodes were 4x4 cm sponge electrodes soaked in sterile saline. For anodal and cathodal tDCS, One electrode was placed over the left DLPFC (F3 from the EEG 10-20 system) located via the Beam F3 measurement system and the other electrode was attached to the right shoulder. For sham tDCS, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.
Interventions
DEVICEanodal tDCS
a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder
DEVICEcathodal tDCS
a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC.
DEVICEsham tDCS
Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria: * 100 Health Individuals recruited from Charleston ,SC
Exclusion criteria
* Can not be pregnant * No history of Depression, chronic pain, Seizers, suicidal implanted metal devices, history of brain surgery, loss of consciousness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Intervention Pain Tolerance | Duration of the study visit, approximately 2 hours | Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception. |
| Post-Intervention Pain Tolerance | Duration of the study visit, approximately 2 hours | Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Correctly Guessed Condition Assignment | 2 hours | Participants guessed whether they received real tDCS or Sham tDCS. The base-rate for correctly guessing real versus sham was 50%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anodal tDCS Plus BCI Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.
anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder | 14 |
| Anodal tDCS Plus Pain-education Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder.
Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder | 15 |
| Cathodal tDCS Plus BCI Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.
cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. | 10 |
| Cathodal tDCS Plus Pain-education Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode attached to the right shoulder and the cathode electrode was placed over the left DLPFC. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. | 13 |
| Sham tDCS Plus BCI Participants underwent Brief Cognitive intervention (BCI) during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.
sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session | 14 |
| Sham tDCS Plus Pain-education Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session | 13 |
| Total | 79 |
Baseline characteristics
| Characteristic | Total | Anodal tDCS Plus BCI | Anodal tDCS Plus Pain-education | Cathodal tDCS Plus BCI | Cathodal tDCS Plus Pain-education | Sham tDCS Plus BCI | Sham tDCS Plus Pain-education |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 14 Participants | 15 Participants | 10 Participants | 13 Participants | 14 Participants | 13 Participants |
| Age, Continuous | 35 years STANDARD_DEVIATION 11.4 | 32.43 years STANDARD_DEVIATION 9.27 | 32.60 years STANDARD_DEVIATION 11.59 | 27.80 years STANDARD_DEVIATION 6.89 | 28.46 years STANDARD_DEVIATION 7.24 | 29.93 years STANDARD_DEVIATION 8.82 | 38.85 years STANDARD_DEVIATION 12.49 |
| Region of Enrollment United States | 79 participants | 14 participants | 15 participants | 10 participants | 13 participants | 14 participants | 13 participants |
| Sex: Female, Male Female | 53 Participants | 9 Participants | 10 Participants | 6 Participants | 8 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 26 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 15 | 0 / 10 | 0 / 13 | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 15 | 0 / 10 | 0 / 13 | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 | 0 / 10 | 0 / 13 | 0 / 14 | 0 / 13 |
Outcome results
Primary
Post-Intervention Pain Tolerance
Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception.
Time frame: Duration of the study visit, approximately 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS Plus BCI | Post-Intervention Pain Tolerance | 47.52 celcius | Standard Deviation 0.98 |
| Anodal tDCS Plus Pain-education | Post-Intervention Pain Tolerance | 47.11 celcius | Standard Deviation 1.07 |
| Cathodal tDCS Plus BCI | Post-Intervention Pain Tolerance | 47.53 celcius | Standard Deviation 1.85 |
| Cathodal tDCS Plus Pain-education | Post-Intervention Pain Tolerance | 47.72 celcius | Standard Deviation 1.72 |
| Sham tDCS Plus BCI | Post-Intervention Pain Tolerance | 47.47 celcius | Standard Deviation 1.39 |
| Sham tDCS Plus Pain-education | Post-Intervention Pain Tolerance | 47.27 celcius | Standard Deviation 0.88 |
Primary
Pre-Intervention Pain Tolerance
Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception.
Time frame: Duration of the study visit, approximately 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS Plus BCI | Pre-Intervention Pain Tolerance | 46.49 celcius | Standard Deviation 1.51 |
| Anodal tDCS Plus Pain-education | Pre-Intervention Pain Tolerance | 47.06 celcius | Standard Deviation 0.92 |
| Cathodal tDCS Plus BCI | Pre-Intervention Pain Tolerance | 46.16 celcius | Standard Deviation 2.15 |
| Cathodal tDCS Plus Pain-education | Pre-Intervention Pain Tolerance | 46.82 celcius | Standard Deviation 2.19 |
| Sham tDCS Plus BCI | Pre-Intervention Pain Tolerance | 46.66 celcius | Standard Deviation 1.36 |
| Sham tDCS Plus Pain-education | Pre-Intervention Pain Tolerance | 47.33 celcius | Standard Deviation 1.04 |
Secondary
Percentage of Participants That Correctly Guessed Condition Assignment
Participants guessed whether they received real tDCS or Sham tDCS. The base-rate for correctly guessing real versus sham was 50%.
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anodal tDCS Plus BCI | Percentage of Participants That Correctly Guessed Condition Assignment | 56 percentage of participants |