Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Conditioning Pain Modulation (CPM)
研究概览
简要总结
This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial [tDCS (active and sham) and aerobic exercise (AE) (active and control)] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.
详细描述
Recent evidence has suggested that FM pain can be related to deficits in pain endogenous regulatory control and that novel non-pharmacological interventions, such as tDCS can modulate this system and, consequently, reduce pain intensity. Widespread pain in FM is thought to represent enhanced pain sensitivity that is maintained by central mechanisms. This suggests changes in the descending pain control mechanisms and a possible relationship with the central sensitization phenomenon. Recent evidence has suggested that pain inhibitory pathways are affected in FM; thus, further understanding these pathways' role can significantly change how the treatment of this condition. In this study the investigators will test the effects of two interventions -tDCS and aerobic exercise - on the modulation of the endogenous inhibitory pain system in fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-65 years,
- •Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis,
- •Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine,
- •Must have the ability to feel sensation by Von-Frey fiber on the forearm,
- •Able to provide informed consent to participate in the study.
排除标准
- •Clinically significant or unstable medical or psychiatric disorder,
- •history of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria),
- •Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported,
- •Previous neurosurgical procedure with craniotomy,
- •Severe depression (If a patient scores >30 on the Beck Depression Inventory, one will obtain clearance. If one does not pass the medical clearance, one will not be included in the study)
- •Pregnancy (as the safety of tDCS in pregnant population (and children) has not been assessed (though risk is non-significant), the investigators will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and at every week of stimulation),
- •Current opiate use in large doses (more than 30mg of oxycodone/hydrocodone or 7.5mg of hydromorphone (Dilaudid) or equivalent),
- •Patients will be excluded when they have increased risk for exercise
结局指标
主要结局
Conditioning Pain Modulation (CPM)
时间窗: 6 weeks
Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6). Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings. Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the three NPS ratings. CPM calculation = (test-stimulus average) - (conditioned-stimulus average). Positive values = better endogenous pain inhibition; negative values = worse.
Temporal Slow Pain Summation (TSPS)
时间窗: 6 weeks
Participants first determined the temperature that elicited Numeric Pain Scale (NPS) = 6 ("pain-6"). Using this temperature, a train of 15 heat pulses (0.4 Hz) was delivered to the right forearm with a TSA-II thermode. Pain was rated using the NPS after the 1st and 15th heat stimulus. TSPS calculation: TSPS = NPS rating after the 15th stimulus - NPS rating after the 1st stimulus. Higher TSPS values represent greater temporal pain summation (worse outcome).
Conditioning Pain Modulation (CPM)
时间窗: 6 weeks
Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6). Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings. Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the three NPS ratings. CPM calculation = (test-stimulus average) - (conditioned-stimulus average). Positive values = better endogenous pain inhibition; negative values = worse.
Temporal Slow Pain Summation (TSPS)
时间窗: 6 weeks
Participants first determined the temperature that elicited Numeric Pain Scale (NPS) = 6 ("pain-6"). Using this temperature, a train of 15 heat pulses (0.4 Hz) was delivered to the right forearm with a TSA-II thermode. Pain was rated using the NPS after the 1st and 15th heat stimulus. TSPS calculation: TSPS = NPS rating after the 15th stimulus - NPS rating after the 1st stimulus. Higher TSPS values represent greater temporal pain summation (worse outcome).
次要结局
未报告次要终点
研究者
Felipe Fregni, MD, PhD, MPH
Director of Spaulding Neuromodulation Center
Spaulding Rehabilitation Hospital