The efficacy of phonophoresis over conventional ultrasound therapy for pain relief in patients with Myofascial Pain Syndrome-a randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Reduction in tenderness on opening the mouth
研究概览
简要总结
AIM: To assess the comparative efficacy of phonophoresis over conventional ultrasound therapy in patients with myofascial pain syndrome.
OBJECTIVE:
Reduction in muscle tenderness
Reduction of pain on opening the mouth
Improvement in mouth opening
HYPOTHESIS: There is no difference in the efficacy of phonophoresis over conventional Ultrasound therapy in patients with myofascial syndrome.
METHODOLOGY:
STUDY DESIGN: Randomized control trial
STUDY DURATION: The study is expected to get completed in 1 months
STUDY POPULATION: Indian nationals in the age group of 18-60 years
INCLUSION CRITERIA: Patients in age group of 18-60 years
Patients who satisfy Laskins criteria for MPDS
Patients not taking any medications /alternate therapy for MPDS
EXCLUSION CRITERIA: Pregnant and lactating women, those with pacemakers, diclofenac allergy, the pain of odontogenic origin, neuralgias, neuromuscular disorders, already treated with anti-inflammatory, muscle relaxant, and analgesic drugs, intraarticular temporomandibular joint disorders, jaw tumors, and trauma.
SAMPLE SIZE: 26
SUBJECT SELECTION: Subjects visiting the OPD of the Department of Oral Medicine and Radiology and satisfying the Laskins criteria for MPDS will be enrolled in the study.
The patient will be informed about the research project and a written consent will be taken if the patient agrees to be a part of the study.
Randomization method: Patients will be allotted to one of the treatment arms through a simple random sampling method
TREATMENT DETAILS: The patients will be randomly divided into two groups of 13 patients each.
Group A will be treated with Ultrasound therapy with anti-inflammatory gel for 8 sittings of 8 minutes each over trigger points , with intensity of 1-1.5 watts per cm2 in continuous mode, Group B will be treated with with Ultrasound therapy without anti-inflammatory gel for 8 sittings of 8 minutes each over trigger points , with intensity of 1-1.5 watts per cm2 in continuous mode.
EXPECTED OUTCOME: Patients being treated with Ultrasound therapy along with anti-inflammatory gel are expected to have quicker/better relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients in age group of 18-60 years Patients who satisfy Laskins criteria for MPDS Patients not taking any medications /alternate therapy for MPDS.
排除标准
- •Pregnant and lactating women, those with pacemakers, diclofenac allergy, the pain of odontogenic origin, neuralgias, neuromuscular disorders, already treated with anti-inflammatory, muscle relaxant, and analgesic drugs, intraarticular temporomandibular joint disorders, jaw tumors, and trauma.
结局指标
主要结局
Reduction in tenderness on opening the mouth
时间窗: After 8 sessions spread over 8 days
Improvement in mouth opening
时间窗: After 8 sessions spread over 8 days
Reduction in individual muscle tenderness
时间窗: After 8 sessions spread over 8 days
次要结局
未报告次要终点
