N/A
Completed N=30
Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis
Source: ClinicalTrials.gov NCT03747640 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS) — -24.67; -3.33 score on a scale
Summary
The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS) |
-24.67; -3.33 | — |
| SECONDARY Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
-12.60; -0.53 | — |
| SECONDARY Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form |
17.13; 16.20 | — |
| SECONDARY Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form |
14.27; 14.27 | — |
| SECONDARY Psychosocial Symptoms as Assessed by PROMIS Depression-short Form |
11.93; 12.20 | — |
| SECONDARY Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form |
18.27; 21.13 | — |
| SECONDARY Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS) |
15.80; 14.80 | — |
| SECONDARY Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI) |
42.67; 38.93 | — |
| SECONDARY Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation |
0.73; -0.78 | — |
| SECONDARY Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS) |
15; 15 | — |
| SECONDARY Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy |
15; 15 | — |
| SECONDARY Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity |
-15.33; 9.67 | — |
| SECONDARY Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee |
.75; -.71 | — |
| SECONDARY Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee |
.69; -.79 | — |
Eligibility Criteria
Inclusion Criteria
- self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
- have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
- can speak and read English
- have a device with internet access that can be used for secure video conferencing for real-time remote supervision
- have no plan to change medication regimens for pain throughout the trial
- are able to travel to the coordinating center
- are willing and able to provide written informed consent prior to enrollment
Exclusion Criteria
- Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
- history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
- alcohol/substance abuse
- cognitive impairment
- pregnancy or lactation
- hospitalization within the preceding year for psychiatric illness
Data sourced from ClinicalTrials.gov (NCT03747640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.