Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: active tDCS paired with active MBM,
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Device: active tDCS paired with active MBM
Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
|
| Active Comparator: sham tDCS paired with active MBM
|
Device: sham tDCS paired with active MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2(milli ampere) mA current for 30 seconds. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
|
| Active Comparator: active tDCS paired with sham MBM
|
Device: active tDCS paired with sham MBM
Active tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
|
| Sham Comparator: sham tDCS paired with sham MBM
|
Device: sham tDCS paired with sham MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
|
Outcome Measures
Primary Outcome Measures
- Change in clinical pain as assessed by the numeric rating scale (NRS) for pain [baseline, week 2]
The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Secondary Outcome Measures
- Change in osteo arthritis symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) [baseline, week 2]
This is a 5 item questionnaire each with a score ranging from none to extreme
- Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system [baseline, week 2]
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
- Descending pain modulation (CPM) as measured by the quantitative sensory testing [baseline, week 2]
Descending pain modulation will be determined by the change in pressure pain threshold on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold water bath at 12°C for one minute, with higher CPM scores indicating better descending pain modulation. Descending pain modulation will be reflected by an increase in pressure pain threshold after cold water immersion.
- Change in mindfulness as measured by the Freiburg Mindfulness Inventory (FMI) [baseline, week 2]
This is a 14 item questionnaire,each scored from 1-4,higher number showing better outcome
- Patient satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) scale [week 2]
This scale has 8 questions,each scored from 1-4,higher number indicating more satisfaction
Eligibility Criteria
Criteria
Inclusion Criteria:
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have symptomatic knee OA based on American College of Rheumatology clinical criteria
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have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain,
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can speak and read English
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have no plan to change medication regimens for pain throughout the trial
Exclusion Criteria:
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history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
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systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia
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alcohol/substance abuse
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current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists
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diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
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pregnancy or lactation
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prosthetic knee replacement or non-arthroscopic surgery to the affected knee
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hospitalization within the preceding year for psychiatric illness
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no access to a device that can be used for secure videoconferencing for real-time remote supervision.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida State University | Tallahassee | Florida | United States | 32306 |
Sponsors and Collaborators
- Florida State University
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Hyochol Ahn, PhD,RN,MSN, Florida State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00002522
- R01NR019051