Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Sleep Disorders in Fibromyalgia Patients : A Double Blinded, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The Medical Outcomes Study Sleep Scale (MOS )
研究概览
简要总结
This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions.
详细描述
This is a prospective double randomized controlled trial that was conducted in Tanta and Assiut University hospitals during the period from 1st October 2022 to the end of March 2023. Sixty four 64 patients with fibromyalgia were recruited from outpatient clinics of Physical Medicine, Rheumatology and Rehabilitation and Neuropsychiatry Departments, Tanta and Assiut University Hospitals. The diagnosis of fibromyalgia was done according to American College of Rheumatology criteria or other standard criteria.
Twenty two cases didn't meet the inclusion and exclusion criteria were excluded: 8 of them had systemic diseases, 5 patients refuse to participate, 4 had contraindication for magnetic stimulation, and 5 cases had primary psychiatric disorders. Forty two cases were eligible and allocated into one of the two groups (1:1 ratio) active rTMS group and sham rTMS group. One case from each group didn't complete the follow up study due to headache and the remaining 20 cases in each group completed the study.
Each patient was subjected to history taking including age of symptoms onset and duration, complete clinical and neurological examination neurological examinations. Fibromyalgia Impact Questionnaire (FIQ) was assessed at base line. Besides, baseline Sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index (PSQI) and The Medical Outcomes Study Sleep Scale (MOS Sleep Scale) respectively .
Randomization All qualified members were haphazardly doled out to one of the two groups. Assignment concealment was done utilizing serially numbered closed, enigmatic envelopes. Each patient was given a serial number from a computer-created randomization table and was put within the suitable group after opening the congruent closed envelope. Counseling for participation was conducted before enrollment.
Procedure of repetitive transcranial magnetic stimulation (rTMS):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 to 50 years.
- •Regular appropriate trial of medical treatment for at least 3 months.
- •Educated participants at least 12 years.
排除标准
- •Inflammatory rheumatic disease, auto immune disease or other painful disorders.
- •Any uncontrolled clinical disease (such as thyroid, cardiovascular, pulmonary, hematological or renal disease) that affect the cognition.
- •pregnancy, lactation.
- •Contra indications for transcranial magnetic stimulation-a history of seizures, brain trauma, brain surgery or intracranial hypertension, a pace maker or other metallic implants.
- •Past history of major sleep disorders(narcolepsy, parasomnia or sleep apnea).
- •Illicit drug or alcohol abuse.
- •Inability to cooperate with the questionnaire survey.
结局指标
主要结局
The Medical Outcomes Study Sleep Scale (MOS )
时间窗: baseline and one month after the end of sessions
Improvement of sleep characteristics in patients with fibromyalgia to treatment with repetitive transcranial magnetic stimulation sessions.
polysomnography
时间窗: baseline and one month after the end of sessions
Improvement of objective sleep parameter abnormalities in patients with fibromyalgia to treatment with repetitive transcranial magnetic stimulation sessions.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: baseline and one month after the end of sessions
Improvement of sleep quality in patients with fibromyalgia to treatment with repetitive transcranial magnetic stimulation sessions.
次要结局
- The Medical Outcomes Study Sleep Scale (MOS)("through study completion, an average of 6 months after the end of sessions")
- Pittsburgh Sleep Quality Index (PSQI)("through study completion, an average of 6 months after the end of sessions")
- polysomnography("through study completion, an average of 6 months after the end of sessions")
研究者
Marwa Y Badr, MD
Principal investigator
Tanta University