The Radiofrequency Therapy in Management of Sickle Cell Disease Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- primary outcome was defined as successful treatment, indicated by patients exhibiting a VAS score below 4 at 30 minutes following the initial first TECAR therapy session.
研究概览
简要总结
The goal of this clinical trial study is to assess effect of radiofrequency on chronic pain of sickle cell disease pain .
All SCA participants who fulfilled inclusion and exclusion criteria were 220; only 170 participant agreed to consent for the study .
Participants who seek frequent medical attention were included in the TECAR group without randomization and they were 15 patients, and the rest of the participants (155 patient) were randomized according to the following ratio as 1:1.2 respectively for both arms arm1: the TECAR group arm 2: the control group .
The main questions to answer are:
primary outcome measure: assess short term effect of TECAR therapy on chronic sickle cell diaease chronic pain by assessment of change in pain scores following 1st TECAR session.
secondary outcomes: assess long term effect of TECAR therapy by assessment of change in chronic pain scores along overall period of study (6weeks).
TECAR (Capacitive and Resistive Energy Transfer device) used:
(C-200 Capenergy Spain)
participants: 2 arms : one arm: TECAR group. 2nd arm: control group. one arm: received TECAR therapy in addition to the standard of care for SCA (hydroxyurea, analgesics [NSAIDs or paracetamol], and blood transfusion on demand).
The second arm received standard of care only. tools used to assess pain:
- VAS questionnaire.
- BPI questionnaire.
- HRQOL questionnaire.
详细描述
This randomized non blinded controlled study was conducted as collaboration between Haematology department in Cairo university Children hospital and the Anaesthesia department in Cairo university hospital from the period between 2022&2024 patients were recruited from Haematology clinic who fulfilled inclusion criteria in absence of exclusion criteria.
Inclusion criteria:
- All types of sickle cell disease (SS/SB0/SB+/SS trait)
- Age of participants ranging from 6 years to 30 years.
- SCA participants with known and unknown cause of chronic pain
Exclusion criteria:
- Those participants with associated chronic disease or end organ damage.
- participants in acute Vaso occlusive crisis.
- Participants on antiepileptics or antidepressant drugs.
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
- 6 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All types of sickle cell disease (SS/SB0/SB+/SS trait)
- •Age of patients ranging from 6 years to 30 years.
- •SCA patients with known and unknown cause of chronic pain
排除标准
- •Those patients with associated chronic disease or end organ damage.
- •patients in acute Vaso occlusive crisis.
- •Patients on antiepileptics or antidepressant drugs.
结局指标
主要结局
primary outcome was defined as successful treatment, indicated by patients exhibiting a VAS score below 4 at 30 minutes following the initial first TECAR therapy session.
时间窗: 30 minutes
We categorized the patients studied according to change in the recorded VAS score between before 1st session and 30 minutes after the first session into the following five subgroups: 1. st group: VAS turned to 0. 2. nd group: VAS turned out to be less than 4. 3. rd group: VAS turned to 4. 4. th group: VAS turned to above 4. 5. th group: VAS remained the same.
次要结局
未报告次要终点
研究者
mai mohamed abdelhamed
assisstant lecturer mai mohamed abdelhamed pediatric department principal investigator
Cairo University