Comparative evaluation of effectiveness of Therapeutic Ultrasound and Transcutaneous Electrical Nerve Stimulation in Temporomandibular Joint Disorder: A Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain sensation using Visual Analogue Scale
研究概览
简要总结
Participants:
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A total of 40 patients aged 18 years and above, diagnosed with Temporomandibular Joint Disorders based on Research Diagnostic Criteria for Temporomandibular Disorders criteria, will be selected.
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They will be randomly divided into two groups:
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Group I: Transcutaneous Electrical Nerve Stimulation therapy (20 patients)
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Group II: Therapeutic Ultrasound therapy (20 patients)
Intervention:
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Group I Transcutaneous Electrical Nerve Stimulation therapy:
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Patients will receive 15-minute Transcutaneous Electrical Nerve Stimulation therapy sessions, twice a week, for 4 weeks.
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Electrical stimulation will be applied via electrodes placed over the Temporomandibular Joint.
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Group II Therapeutic Ultrasound therapy:
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Patients will undergo 5–10-minute therapeutic ultrasound sessions, twice a week, for 4 weeks.
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Continuous mode ultrasound at 1.0–3.0 MHz frequency will be used.
Assessment:
- Pain will be evaluated using the Visual Analog Scale before and after each session.
- Clinical signs of TMD will be recorded as per Research Diagnostic Criteria for Temporomandibular Disorders criteria.
- Patients will be followed up monthly for 3 and 6 months.
Study Design and Analysis:
- The study will be a randomized controlled trial with allocation concealment and double blinding.
- Data will be collected and statistically analyzed using suitable tests (e.g., t-test, Wilcoxon, ANOVA) to compare the effectiveness of Transcutaneous Electrical Nerve Stimulation therapy and Therapeutic Ultrasound therapy.
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 and Investigator 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 aged above 18 years with pain associate with TMD will be included as per RDC/TMD criteria.
- •Patient who are willing to participate in the study.
排除标准
- •Temporomandibular joint dislocation Malignancy in head and neck region Open wounds, burns ,infections or fracture at operating region.
- •Systemic disorders Presence of metal implants in TMJ.
- •Hairy surfaces interfering with assessment Neurological and Radiological deficits Pregnant women.
结局指标
主要结局
Pain sensation using Visual Analogue Scale
时间窗: Baseline | 3 months | 6 months
次要结局
未报告次要终点
研究者
Dr Trupti Doma Gharde
Sinhgad Dental College and Hospital, Pune