Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
- Conditions
- Osteo Arthritis Knee
- Interventions
- Device: active tDCS paired with active MBMDevice: sham tDCS paired with active MBMDevice: active tDCS paired with sham MBMDevice: sham tDCS paired with sham MBM
- Registration Number
- NCT04375072
- Lead Sponsor
- University of Arizona
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- have symptomatic knee OA based on American College of Rheumatology clinical criteria
- have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain,
- can speak and read English
- have no plan to change medication regimens for pain throughout the trial
- history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia
- alcohol/substance abuse
- diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
- pregnancy or lactation
- prosthetic knee replacement or non-arthroscopic surgery to the affected knee
- hospitalization within the preceding year for psychiatric illness
- no access to a device that can be used for secure videoconferencing for real-time remote supervision.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active tDCS paired with active MBM, active tDCS paired with active MBM - sham tDCS paired with active MBM sham tDCS paired with active MBM - active tDCS paired with sham MBM active tDCS paired with sham MBM - sham tDCS paired with sham MBM sham tDCS paired with sham MBM -
- Primary Outcome Measures
Name Time Method Numeric Rating Score (NRS) of Pain 14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention) Clinical pain intensity will be measured by asking participants to rate average knee pain over the past 24 hours via NRS from 0 (no pain) to 100 (worst pain imaginable), as in the investigator's previous pilot trial. The NRS has a reported Cronbach's alpha coefficient of ≥ 0.8 and is a well-validated measure with good ability to detect pain change in adults with knee OA.
- Secondary Outcome Measures
Name Time Method Conditioned Pain Modulation (CPM) 3 time points (baseline and weekly during the treatment period) 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.
Side effects questionnaire 10 time points: 5 times a week daily for up to 2 weeks Side effects questionnaire will be evaluated for the presence and severity of possible side effects of treatment at the end of each session on a 0 (not at all) to 10 (highest degree) scale. The participants will be asked in an open-ended manner whether any side effects are experienced, and participants will complete a brief questionnaire assessing side effects of treatment, including side effects that can occur with tDCS or MBM (e.g., itching, headache, fatigue, dizziness).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2,and 3 post-intervention) This is a 5 item questionnaire each with a score ranging from none to extreme
Functional near-infrared spectroscopy (fNIRS) brain imaging 3 time points (baseline and weekly during the treatment period) 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.
Client Satisfaction Questionnaire (CSQ-8) at the end of 2-week intervention Client Satisfaction Questionnaire (CSQ-8) will measure participants' satisfaction with treatment. The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has a reported Cronbach's alpha coefficient of 0.87-0.93.
Freiburg Mindfulness Inventory (FMI) 6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2, and 3 post intervention) Freiburg Mindfulness Inventory (FMI) will measure levels of mindfulness among participants. It is a 14-item instrument (range, 14 to 56), with higher scores indicating more skill with the mindfulness technique. The FMI has a reported Cronbach's alpha coefficient of 0.86.
Trial Locations
- Locations (1)
University of Arizona
🇺🇸Tucson, Arizona, United States