Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Stroke Specific Quality of Life Scale (SS-QoL)
研究概览
简要总结
The aim of our study is to investigate transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.
详细描述
After ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rTMS with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rTMS with conventional rehabilitation, and those undergoing only conventional rehabilitation. The TMS group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke
排除标准
- •Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants
研究组 & 干预措施
active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome
The intermittent theta-burst stimulation (iTBS) intensity for patients, applied under doctor supervision for a total of 5 days over one week (from Monday to Friday), will be set at 70% of the resting motor threshold. Stimulation will consist of bursts at a frequency of 50 Hz, with 3 bursts every 10 seconds, each burst lasting 2 seconds, totaling 600 bursts. Subsequently, the resting motor threshold will be adjusted to 80%, and a total of 2000 bursts will be delivered at a frequency of 10 Hz, repeated every 30 seconds, each lasting 10 seconds.
干预措施: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) (Device)
sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome
Similar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group.
干预措施: Sham transcranial magnetic stimulation (Device)
conventional rehabilitation program in stroke patients with complex regional pain syndrome
Only a conventional rehabilitation program consisting of discontinuous ultrasound, transcutaneous electrical nerve stimulation (TENS), and contrast bath, formed by 5 sessions, will be applied to this group.
干预措施: conventional rehabilitation program (Device)
结局指标
主要结局
Stroke Specific Quality of Life Scale (SS-QoL)
时间窗: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
The SS-QoL is an instrument specifically used to assess health-related QoL among individuals who experienced stroke. It has 49 items in 12 domains, varying from 49 to 245 points, with responses varying from 1 to 5 points. Higher values indicate better health-related QoL.
Brunnstrom's Hemiplegia Recovery Staging
时间窗: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
According to Brunnstrom, the stages of recovery in patients developing paralysis due to stroke progress as follows: Stage 1, where muscles are completely flaccid; Stage 2, the emergence of muscle synergies; Stage 3, the peak of involuntary movements; Stage 4, a decrease in involuntary movements and the initiation of voluntary movements; Stage 5, the appearance of more coordinated movements; Stage 6, the disappearance of spasms and the observation of fine joint movements, approaching near-complete recovery; Stage 7, where all functions return to normal.
Visual Analog Scale (VAS)
时间窗: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
A 10 cm Visual Analog Scale (VAS) has been used to objectively assess widespread body pain in patients. Participants use this scale to determine the intensity of their pain. While 0 represents no pain, 10 indicates the most severe pain experienced by the individual.
次要结局
- Fugl Meyer Upper Extremity Assessment(Before treatment (initial), at the end, four weeks after treatment)
研究者
Özlem Yücealp
Research Assistant in Physical Medicine and Rehabilitation
Ankara City Hospital Bilkent