Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Recovery in time
研究概览
简要总结
Bell´s Palsy, a lower motor neuron injury that causes facial asymmetry due to facial weakness ranging from mild to total paralysis. Most of cases without determining a definitive established cause. The only authenticated findings are inflammation and edema of the facial nerve. In Mexico, it is among the first causes of medical attention. In the Mexican Clinical Practice Guide for Bells Palsy, thermotherapy, massage, and active exercises are recommended for its management. Perineural dextrose injection therapy (PIT) is a new treatment for peripheral neuropathy, which consists of injecting 5% buffered dextrose close to nerve pathways to restore nerve function and movement. Objective: Determine the effectiveness of perineural injection with dextrose versus conventional physical therapy for the treatment of patients with Bell´s palsy. Material and methods: Clinical trial, experimental, prolective, longitudinal, comparative and heterodemic. Resources and infrastructure: It will be carried out within the facilities of the Unidad de Medicina Física y Rehabilitación región centro. In human resources, doctors both specialists and residents in Rehabilitation Medicine and physical therapists. In material resources, stationery, for electroneuromyography study, perineural injection therapy, hand hygiene and disinfection, and for conventional rehabilitation therapy.
详细描述
This study aims to evaluate the efficacy of dextrose perineural injection therapy while motivating and serving as a foundation for future studies to compare or create alternatives and therapeutic methods tailored to the needs patients, with the goal of improving functionality and aesthetics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- Baseline: Adequate assembly with balanced groups through randomization and clinical stratification.
- Execution: Proper application of the experimental maneuver with established doses at each injection point.
- Outcome: Same number of evaluations in both groups and a 20% increase in sample size in case of losses.
- Masking: Triple-blind study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria: Patients with Bell's Palsy who:
- •Age 18 years and older.
- •Both male and female.
- •Duration of symptoms longer than 6 days.
- •Apparently healthy, without any associated comorbidities such as diabetes mellitus, obesity, hypothyroidism, hyperthyroidism, metabolic syndrome, or any neurological disorder.
- •Grade III (moderate dysfunction), IV (moderate to severe dysfunction), V (severe dysfunction), or VI (total paralysis) according to the House-Brackmann Classification.
- •Exclusive attention from UMF 2, 3, 4, 6, 11, 16, 29, 34, 35, 42, 94, 120 and the Physical Medicine and Rehabilitation Unit in the central region (employers and beneficiaries).
- •Exclusive attention from the UMF belonging to Mexico City (beneficiaries only).
- •Patients willing to participate in the study confirmed with signed informed consent.
排除标准
- •Active smokers.
- •Patients with central facial paralysis.
- •Patients with peripheral facial paralysis secondary to tumors or surgical treatment.
- •Patients experiencing more than second episode of Peripheral Facial Paralysis.
- •Patients with cognitive and/or mental impairments.
- •Patients undergoing additional private therapy.
- •Patients with bilateral facial paralysis.
- •Pregnant patients.
- •Patients unwilling to participate in the study.
- •Patients who have received prior rehabilitation, laser, electrotherapy, or acupuncture.
- •Elimination Criteria:
- •Patients who do not attend rehabilitation sessions.
- •Patients diagnosed with Sars-cov2 infection during the study.
- •Patients who discontinue treatment.
- •Patients developing other pathologies requiring special treatment.
- •Patients wishing to withdraw from the study.
研究组 & 干预措施
Grupo experimental:
Experimental Group: Patients who meet the inclusion and exclusion criteria, to whom perineural injection with dextrose and conventional physical therapy will be applied for the treatment of Bell's palsy.
干预措施: inyección perineural con solución de dextrosa tamponada (Procedure)
Control:
Control Group: Patients who meet the inclusion and exclusion criteria, to whom only conventional physical therapy will be applied for Bell's palsy.
结局指标
主要结局
Recovery in time
时间窗: 1= ≥8 weeks 2= ≤ 8 weeks
It is the action and effect of recovering or recovering (returning to oneself or to a normal state, take back what you had before, compensate) in a set time.
Efficacy in functionality
时间窗: ≥8 weeks
A= Functionality facial B= Recovery in time
Functionality facial
时间窗: ≥8 Weeks or ≤ 8 weeks
1. Manual examination of facial muscles. It is a clinical evaluation to determine the function and strength of a person's facial muscles. 2. Clinical evaluation. The House-Brackmann rating scale used to evaluate facial function and severity of facial paralysis peripheral, which consists of six levels to evaluate six facial expressions starting from normal (grade I) and as the last degree considers total paralysis (grade VI). 3. Assessment electrophysiological with study of electroneurography of facial nerve that consists of the neuro conductions that they involve electrical stimulation of the nerve by measuring its motor response.
次要结局
未报告次要终点
研究者
Celia Itxelt Infante Castro
Clinical Coordination of Health Education and Research.
Instituto Mexicano del Seguro Social