Assessment of Efficacy of Pulsed Electromagnetic Field therapy on Temporo Mandibular Joint Pain in patients with Malocclusion.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- significant pain relief after conventional splint therapy along with active PEMF therapy
研究概览
简要总结
Thisstudy is a randomized, prospective clinicaltrial to assess the efficacy of PulsedElectro Magnetic Field (PEMF) therapy in patients with malocclusion associatedwith pain in the Temporo-Mandibular joint (TMJ) region. The study includes a samplesize of 134 subjects, with pain in the TMJ region, who will be diagnosed basedon Research Diagnostic Criteria (RDC), reporting to Meenakshi Ammal DentalCollege, Chennai, Tamilnadu, India.
Patientswho meet the selection criteria will be randomly divided into two study groupsnamely Group – I (Control group) and Group – II (Experimental group) with 67patients in each group. In Group-I,patients will be treated with conventional splint therapy. In Group- II, patientswill be provided with conventional splint therapy along with active PEMFtherapy. The frequency of wear of the device will be around 6-8 hours per dayduring night time with duration of around 21 to 45 days. In both the groups,the patients will be evaluated for the pain relief using the assessment scale(universal pain assessment tool) at the following intervals: T0 (before deviceinsertion), T1 (after 2 weeks), T2 (after 4 weeks) and T3 (after 6 weeks). After 6 weeks, effectiveness of treatment andpost treatment changes will be evaluated using patient’s global impression ofchange (PGIC) scale.
The outcome of the study is to assess significantpain relief after conventional splint therapy along with active PEMF therapyand to validate the use of PEMF as an effective non-invasive adjunct method oftreatment for pain in TMJ region in patients with malocclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 17.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Ambulatory patients with malocclusion who requires fixed orthodontic treatment.
- •Individuals with clinically evident jaw deviation during mouth opening associated with pain in one or both the TM joints – diagnosis based on RDC.
- •With or without clicking sounds in the TMJ region.
- •Absence of one or more teeth.
排除标准
- •Systemic illnesses, no cardiac disease, no pacemaker, or other conditions that could be affected by radio frequency discharge beams.
- •Presence of local infection or any other dental pain.
- •Prosthetic joint replacement or placement of any metallic surgical device in or around the area of treatment.
- •Interarticular steroid injection in the past three months.
- •Any medical or psychological disorder that might affect the pain threshold.
- •Constant dose of NSAID or narcotic analgesic drugs 7) Other therapeutic modality during the period of the study.
结局指标
主要结局
significant pain relief after conventional splint therapy along with active PEMF therapy
时间窗: every 2 weeks for 6 weeks
次要结局
- using PEMF as an effective non-invasive adjunct method of treatment for pain in TMJ.(6 weeks)