Effectiveness of Percutaneous Microelectrolysis in the Decrease of Pain in Myofascial Trigger Points: Evaluation Through Algometry and Visual Analog Scale. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain Pressure Threshold (PPT)
研究概览
简要总结
The aim of the design is to investigate the value of percutaneous microelectrolysis (MEP) as an analgesic technique in myofascial trigger points. This research seeks to evaluate influence of cathode polar effects on the reduction of painful pressure (PPT) threshold and pain intensity (PI) in the myofascial trigger points (MTrPs) of upper trapezius muscle. An assessment with algometry and visual analog scale (VAS) will be made before applying the intervention. The study will evaluate changes in PPT and PI in a group exposed to percutaneous microelectrolysis (MEP) aplication compared to control group. Both groups will be provided with a baseline treatment of therapeutic ultrasound. Treatment will include three evaluation sessions. Subsequently, researchers will proceed to compare PPT and PI obtained from algometry test and VAS in each groups, and between groups, before and after the intervention. Changes obtained between sessions will be compared.
详细描述
- Methodological design
Type: Experimental, randomized clinical trial (RCT).
1.1 Study population. Students of Science Rehabilitation Faculty (SRF) of Andrés Bello University constituted by the careers of Kinesiology, Occupational Therapy and Speech Therapy.
1.2 Ethical aspects of research. Study was approved by ethics committee of Metropolitan East Health Service (SSMO),Santiago de Chile, to ensure compliance with bioethical regulations. Study was approved by Bioethics Committee on June 26, 2018. An informed consent will be applied to participants in which the study and intervention procedures will be explained. 2. Variables. 2.1 Conceptual definition of the variables • Pain pressure threshold (PPT): magnitude of pain in Kg/cm2 reported by participants when performing algometry test in upper trapezius muscle.
- Pain Intensity (PI): magnitude of pain in millimeters (mm) referred by participants when performing the pressure algometry test in MTrP of upper trapezius muscle.
- Percutaneous Microelectrolysis (MEP): application of direct current through an acupuncture needle with intensities in microamps (μA) in the MTrP of upper trapezius muscle. Acupuncture needle will correspond to negative electrode or cathode. Intensity will be 610μA at MTrP.
- Therapeutic ultrasound: conventional ultrasound application (US) on MTrP with a 1MHz treatment frequency, 1.5W/cm2, 5cm2 ERA, 100% duty cycle, 15 minutes treatment time. US therapy was applied to both groups equally as baseline traetment.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria
- •Students of Sciences Rehabilitation Faculty.
- •Participants over 18 years old.
- •Participants presenting Hypersensitive Pain Points (Trigger Points) at level of upper trapezius muscle. The positive trigger point (+) will be the presence of pain at a pressure of less than 3kg/cm2 at muscle point.
排除标准
- •Musculoskeletal problems or pathologies of the neck or shoulders in the last 6 months (fractures, sprains, tendinopathies, dislocations, muscle tears, etc.).
- •Participants who present cervical pain.
- •Presence of osteosynthesis materials near shoulders, neck or surrounding areas
- •Alterations of sensitivity such as hypesthesia, anesthesia or hyperesthesia in the neck, shoulders and / or arms
- •Presence of wounds or skin alterations in the shoulder region (psoriasis, scars, keloids).
- •Apprehension or fear of electrotherapy aplication.
- •Ingestion of medications or analgesic pharmacological treatment at time of recruitment (Non-steroidal anti-inflammatory or steroidal).
- •Elimination Criteria
- •Non-tolerance of electrotherapy intervention that requires suspension of treatment.
- •Non-completion of evaluation protocol (attendance at all scheduled sessions).
结局指标
主要结局
Pain Pressure Threshold (PPT)
时间窗: PPTpre1 (baseline), PPTpost1 (post baseline), PPT2 (Day 3), PPT3 (Day 7), assessed an average of 30 minutes at each session
Pain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by participants when performing algometry test at sensitive point of upper trapezius muscle. PPT was valued in four occasions: PPT1 pre (baseline), PPT1 post, PPT 2 (at day 3) and PPT 3 (at day 7). PPT will be evaluated through the BASELINE® pressure algometer.
次要结局
- Pain Intensity (PI)(PIpre1 (baseline), PIpost1 (post baseline), PI2 (Day 3), PI3 (Day 7), assessed an average of 3 minutes at each session)
研究者
Hernán Andrés de la Barra Ortiz
Clinical Professor
Quiropraxia y Equilibrio