N/A
Completed N=41
Transcranial Direct Current Stimulation in Older Persons With Knee Pain (Knee Pain and tDCS): Randomized Pilot Study
Source: ClinicalTrials.gov NCT02512393 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Numeric Rating Scale (NRS) for Pain — 27.25; 19.00 units on a scale
Summary
The purpose of this research is to study the effects of Transcranial Direct Current Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a better understanding of the factors that cause pain and disability in people with knee osteoarthritis (OA). In particular, people from different ethnic and racial groups may experience OA pain differently which is why the focus will be on older Asian Americans and non-Hispanic whites. It is important to find a reason for such difference so that a better treatment can be found for all OA patients. In addition, the research study will examine if there is any ethnic differences in pain and mobility disability. The investigator hypothesize that Asian Americans will report greater pain and mobility disability than non-Hispanic whites, and that active tDCS will result in improvement in pain and disability compared to sham tDCS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) for Pain |
8.75; 12.55 | — |
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale |
24.20; 19.50 | — |
| PRIMARY Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale |
1.29; 1.60 | — |
| PRIMARY Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale |
0.96; 1.15 | — |
| PRIMARY Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale |
0.54; 0.66 | — |
| PRIMARY Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale |
0.61; 0.77 | — |
| PRIMARY Six-minute Walk Test |
497.47; 494.26 | — |
| PRIMARY Short Physical Performance Battery (SPPB) |
11.25; 11.05 | — |
| PRIMARY Heat Pain Threshold |
42.62; 40.18 | — |
| PRIMARY Heat Pain Tolerance |
47.07; 45.42 | — |
| PRIMARY Pressure Pain Threshold |
3.21; 2.98 | — |
| PRIMARY Punctate Mechanical Pain Sensitivity |
42.23; 50.73 | — |
| PRIMARY Conditioned Pain Modulation (CPM) |
0.94; 0.70 | — |
| SECONDARY Endorphin Level |
0.04; 0.05 | — |
| SECONDARY Cortisol Level |
46588.50; 38853.23 | — |
| SECONDARY C-reactive Protein (CRP) Level |
1496.74; 3372.98 | — |
| SECONDARY Tumor Necrosis Factor (TNF) Level |
7.41; 10.36 | — |
| SECONDARY Interleukin 6 (IL-6) Level |
2.40; 3.37 | — |
| SECONDARY Interleukin 10 (IL-10) Level |
5.68; 8.17 | — |
Eligibility Criteria
Inclusion Criteria
- they have self-reported unilateral or bilateral knee OA pain according to American College of Rheumatology criteria
- they can understand, speak and read English
- they are able to walk for 6-minutes
- they are willing to be randomized to either the intervention or control group
- they are available for five consecutive daily sessions and for a follow-up phone interview each week for three weeks post-stimulation sessions
- they have no plan to change medication regimens for pain throughout the trial
- they are willing and able to provide written informed consent
Exclusion Criteria
- knee replacement or non-arthroscopic surgery to the affected knee
- serious medical illness, such as uncontrolled hypertension (i.e., Systolic Blood Pressure/Diastolic Blood Pressure of ≥ 150/95), congestive heart failure, pacemaker, or history of acute myocardial infarction
- peripheral neuropathy
- systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- alcohol/substance abuse
- cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
- history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
- pregnancy or lactation for females
- hospitalization within the preceding year due to psychiatric illness
Data sourced from ClinicalTrials.gov (NCT02512393). 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.