Transcranial Direct Current Stimulation in Older Persons With Knee Pain: Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
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.
详细描述
If you participate in the study, the following will happen:
Randomized into one of two groups. Which will either receive the full length session of brain stimulation or a much shorter session of brain stimulation. The shorter version of stimulation looks like and is performed in the same way as the longer electrical stimulation session, but stimulation is stopped before it can have much of an effect on the brain. You will not know which group you have been assigned to while participating in the research, but you may find out at the completion of the research study.
X-Rays will be done on both knees while standing up.
Questionnaires about arthritis pain you are having, your thoughts and feelings about it, and any stress that you may have experienced.
Walking Test will be performed on a flat surface for 6 minutes at a fast pace without help from an assistive device (cane or walker) or another person.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pressure Pain Threshold
时间窗: day 5
Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Heat Pain Tolerance
时间窗: day 5
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
时间窗: day 5
This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
时间窗: day 5
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Numeric Rating Scale (NRS) for Pain
时间窗: day 5
Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
时间窗: day 5
This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
时间窗: day 5
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Six-minute Walk Test
时间窗: day 5
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Punctate Mechanical Pain Sensitivity
时间窗: day 5
Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
时间窗: day 5
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short Physical Performance Battery (SPPB)
时间窗: day 5
This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Heat Pain Threshold
时间窗: day 5
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Conditioned Pain Modulation (CPM)
时间窗: day 5
Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
次要结局
- Interleukin 6 (IL-6) Level(day 5)
- Tumor Necrosis Factor (TNF) Level(day 5)
- Endorphin Level(day 5)
- Cortisol Level(day 5)
- Interleukin 10 (IL-10) Level(day 5)
- C-reactive Protein (CRP) Level(day 5)
研究者
Hyochol Ahn
Associate Professor
The University of Texas Health Science Center, Houston