The Effect of Ultrasound-Guided Stellate Ganglion Block on Pain, Functionality, and Quality of Life in Type 1 Complex Regional Pain Syndrome in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The aim was to investigate the effect of Stellate Ganglion Blockade, which will be applied in addition to conventional physical therapy, on pain and functionality in patients with poststroke complex regional pain syndrome.
详细描述
Post-stroke complex regional pain syndrome (CRPS) is relatively common in hemiplegic upper extremity. Complex regional Pain Syndrome Type 1 is often seen without any nerve damage especially post-stroke. This musculoskeletal disorder usually effects motor improvement, quality of life and Daily living activities. Besides Presence of CRPS is thought to be challenging on the way of rehabilitation process. However, disproportionate sympthatic nervous system activation, disinhibition of the descenden neuronal pathways are the mechanisms thought to be taken place in the etiopathogenesis of CRPS, it still remains unclear. Pharmacological agents, Physical Therapy techniques, exercise and injections are used to treat CRPS. Therefore post-stroke patients have co-morbidities and multi-drug usage, it should be take into account to treat them with physical therapy agents and interventional procedures. Stellat ganglion blockade is an interventional technique that is used to break the vicious circle of symphatetic activation of upper extremity in CRPS. However to the best of our knowledge there are not any study that evaluates the effect of stellat ganglion Blockade on CPRS combining conventional physical therapy. Total of 32 patients with post-stroke CPRS are going to be participated in the study. Patients are going to be divided into two groups. Group 1 is going to receive both onventional physical therapy, exercise (10 sessions) and stellat ganglion blockade and Group 2 is going to receive just conventional physical therapy program and exercise therapy (10 sessions). Participants are going to evaluate before treatment, 2 weeks and 12 weeks after the end of the therapy sessions. Visual analog scale (VAS), Brunnstroom stages of stroke recovery (BSSR), Fugl-meyer (FMUE) and Stroke spesific quality of life (SSQoL) are used to evaluate pain, functionality and quality of life.
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 (Investigator, Outcomes Assessor)
盲法说明
The researcher conducting the evaluations will not know the group the patient will be assigned to. The other researcher will determine which group the patient will be assigned to through randomization and will perform the intervention if the patient is in the stellate ganglion group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer male and female patients aged 18-75
- •Diagnosed with Complex Regional Pain Syndrome according to the IASP 2012 Diagnostic Criteria
- •Patient's pain level must be VAS >4
排除标准
- •Presence of existing neurological diseases other than rheumatic diseases and stroke
- •General impairment
- •Conditions that would constitute a contraindication to application, such as an open wound or sensory deficit in the application area
- •Presence of active infection
- •Presence of malignancy
- •Cognitive dysfunction (mini mental test result <23)
研究组 & 干预措施
Stellat Group
In group 1, stellate ganglion blockade will be applied in addition to conventional physical therapy.
干预措施: Stellate Ganglion Block (Procedure)
Only Physical Therapy Group
Group 2 will receive only conventional physical therapy and exercise therapy
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Before treatment, 2 weeks and 12 weeks after the end of sessions
Ten-cm VAS was used as a self-report measure for lower back pain intensity. Self reported pain measurement score is between 0-10 and higher scores indicates higher pain severity.
Visual Analog Scale (VAS)
时间窗: Before treatment, 2 weeks and 12 weeks after the end of sessions
Ten-cm VAS was used as a self-report measure for lower back pain intensity. Self reported pain measurement score is between 0-10 and higher scores indicates higher pain severity.
次要结局
- Brunnstroom stages of stroke recovery (BSSR)(before treatment, 2 weeks and 12 weeks after the end of the therapy sessions)
- Fugl-Meyer Upper Extremity (FMUE) Scale(before treatment, 2 weeks and 12 weeks after the end of the therapy sessions)
- Stroke Specific Quality of Life scale (SS-QOL).(before treatment, 2 weeks and 12 weeks after the end of the therapy sessions)
研究者
Seher KALIÇ
Principle Investigator
Ankara City Hospital Bilkent