The Effects of Cognitive Behavioral Therapy (CBT) and Transcranial Direct Current Stimulation (tDCS) on Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Baseline Quantitative Sensory Testing (QST)
研究概览
简要总结
Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.
详细描述
Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
- •Between the ages of 21 and 85
排除标准
- •Other chronic pain conditions
- •on chronic opioid therapy
- •history of seizures
- •are or might be pregnant
- •metal/electronic implants or devices above the waist
- •moderate to severe depression (HDRS >19)
- •moderate to severe anxiety (BAI >16)
- •Latex allergy
- •Psychiatric illness other than mild depression or anxiety
- •on medications that lower seizure threshold
研究组 & 干预措施
Sham tDCS Stimulation
30 minutes of the sham transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
干预措施: Transcranial Direct Current Stimulation (Device)
Anodal tDCS Stimulation of DLPFC
30 minutes of the active transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Baseline Quantitative Sensory Testing (QST)
时间窗: Before Treatment
Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Post Baseline Quantitative Sensory Testing (QST)
时间窗: One week Post Treatment
After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
次要结局
- Affective Subscale of McGill Pain Questionnaire at Baseline(Before Treatment)
- The Fibromyalgia (FM) Impact Questionnaire at Baseline(Before Treatment)
- The Short-Form 12 Healthy Survey at Baseline(Before Treatment)
- The Beck Depression Inventory (BDI) at Baseline(Before Treatment)
- The Beck Anxiety Inventory (BAI) at Baseline(Before Treatment)
- Brief Pain Inventory-Average Pain at Baseline(Before Treatment)
- Percent Change in Average Daily Pain at Treatment Visit 3(Treatment Session 3 (week 3))
- The Beck Depression Inventory (BDI) at 1 Month Follow up(1 month follow up)
- The Beck Anxiety Inventory (BAI) at 3 Month Follow Up(3 Month Follow Up)
- Brief Pain Inventory-Average Pain at 1 Month Follow Up(1 Month Follow Up)
- Percent Change in Average Daily Pain at Treatment Visit Six(Treatment Session 6 (week 6))
- Percent Change in Average Daily Pain at 1 Month Follow Up(1 Month Follow Up)
- Percent Change in Average Daily Pain at 3 Month Follow Up(3 Month Follow Up)
- Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up(1 Month Follow Up)
- The Short-Form 12 Healthy Survey at 1 Month Follow Up(1 Month Follow Up)
- The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up(1 Month Follow Up)