Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

Osteo Arthritis Knee Clinical Trial

Official title:

Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375072
• Other study ID #: STUDY00003164
• Secondary ID: R01NR019051R01NR
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: University of Arizona
• Contact: Hyochol Ahn, PhD,RN,MSN
• Phone: 520-626-1769
• Email: hbrian[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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 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 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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Score (NRS) of Pain	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.	14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention)
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	This is a 5 item questionnaire each with a score ranging from none to extreme	6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2,and 3 post-intervention)
Secondary	Functional near-infrared spectroscopy (fNIRS) brain imaging	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.	3 time points (baseline and weekly during the treatment period)
Secondary	Conditioned Pain Modulation (CPM)	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.	3 time points (baseline and weekly during the treatment period)
Secondary	Freiburg Mindfulness Inventory (FMI)	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.	6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2, and 3 post intervention)
Secondary	Client Satisfaction Questionnaire (CSQ-8)	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.	at the end of 2-week intervention
Secondary	Side effects questionnaire	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).	10 time points: 5 times a week daily for up to 2 weeks