A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin a on the Relief of Jaw Muscles Myofascial Pain
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pressure pain threshold
研究概览
简要总结
This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .
The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.
The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.
The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.
The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .
At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.
Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient with myofascial trigger points in masseter or temporalis previously ----*identified by manual palpation.
- •18 years or More "Willingness to follow instructions.
排除标准
- •therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.
- •Clinical conditions as pregnancy
- •Medical problems that will interfere with the procedure as bleeding disorders.
- •Cognitive impairment or present inadequate cooperation.
研究组 & 干预措施
Botulinum toxin A
20 Patients with Myofascial pain will be injected by 5 units botulinum toxin A per trigger point in masseter and/or temporalis
干预措施: Botulinum Toxin A / Botulinum Toxin A (Drug)
结局指标
主要结局
Pressure pain threshold
时间窗: 3 months
The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point.. Will be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment
Current pain intensity
时间窗: 3 months
The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome
Worst pain intensity
时间窗: 3 months
The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain . Decrease in pain intensity means better outcome
次要结局
- Inter incisal opening(3 months)
- Patient satisfaction(3 months)
- The need for analgesics(3 months)
研究者
asmaa abdelrahman abdelhakeem sayed
Principal investigator
Cairo University