Shockwave Effectiveness in Myofascial Pain of the Upper Trapezius Muscle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Algometric evaluation
研究概览
简要总结
Focused shockwaves are generated electrically, either within the applicator (electrohydraulic technique), or externally to it in the focal zone (electromagnetic or piezoelectric techniques), and then propagate to a designated focal point in order to treat it. Most research in shockwave therapy has focused on understanding the mechanism which results in the establishment of a mechano-sensitive feedback loop between the acoustic impulse and the stimulated cells, and involves specific transduction pathways and gene expression. Taking as valid the current physiopathological hypothesis of myofascial pain (MPS) and considering the mechanotransduction effect of ESWT in other diseases, it could be posited that ESWT in MPS may increase perfusion, promote angiogenesis and alter the pain signaling in ischaemic tissues caused by the influx of calcium. On the other hand, recent articles have demonstrated that free nerve endings degenerate after the application of ESWT, and that ESWT produces a transient dysfunction of nerve excitability at the neuromuscular junction, by bringing about the degeneration of AChR. Finally, following a pure mechanistic approach, shockwaves might be able to break-up the Actine-myosin links, as they are propagating perpendicularly to the sarcomere contractions.
Study Hypothesis: To obtain pain relief and improvement in functional and quality of life scales, by performing 3 ESWT sessions, 1 per week (0,10 mJ/mm2; 2000 impulses; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.
Primary objective: To analyze the effectiveness of Focused Shockwave Treatment in myofascial pain of the upper trapezius muscle.
详细描述
This is a single blind randomized clinical trial that will be conducted in Quirónsalud Barcelona, Spain. The study will enroll 60 patients suffering of myofascial pain of the upper trapezius muscle over a 5-months period. The overall duration of the trial will be approximately 8 months. The trial will end when the last subject has the last visit, at 12 weeks (3 months).
This protocol calls for 7 visits to be performed over a 12-weeks period for each patient.
This study will enroll 60 patients suffering of myofascial pain of the upper trapezius muscle.
Treatment Assignment Procedures i. Randomization Procedures: The investigators will use block randomization, which is commonly used in the two treatment situations where the samples of the two treatments must be equal or equally equal. The process will involve recruiting participants in short blocks and ensuring that half of the participants within each block are assigned to "A" and the other half to "B". Within each block, however, the order of patients will be random. The patients will be considered blocks of four dimensions: 1. AABB, 2. ABAB, 3. ABBA, 4. BAAB, 5. BABA, 6. BBAA. The investigators will randomly select between these six different blocks for each group of four recruited participants. The random selection will be done using a list of random numbers generated using statistical software (Excel).
ii. Masking Procedures: The participants will be blinded to the type of ESWT treatment and the assessor, data managers, statistician and study monitors will be blinded to the allocation. All participants who receive ESWT treatment will be treated using the same device (Duolith® SD-1 STORZ Medical, Switzerland) regardless of what group patients are included in. The participants will not be able to predict the allocated group based on the appearance of the ESWT treatment. The blinding will be maintained until the data are locked. For blinding evaluation, allocation guessing will be assessed immediately after the final treatment. Practitioners and assessors will be instructed to treat the participants according to predefined standard operating procedures during the trial to maintain blinding.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •No range of motion restriction
- •Informed consent signed
- •Diagnosis of myofascial pain of the upper trapezius muscle.
- •Myofascial pain of the upper trapezius muscle non-responsive to physioterapic treatments
排除标准
- •Age < 18 years
- •Restricted range of motion
- •Tumor in the area to be treated
- •Wound in the area to be treated
- •Coagulation disorders or anticoagulant therapy
- •Local infection
- •Pregnancy
结局指标
主要结局
Algometric evaluation
时间窗: 12 weeks
Pressure algometry \[PA\] is employed for quantification of tenderness in diagnosis of tender spots, trigger points, fibromyalgia and muscle spasm.
VAS (Visual Analogue Scale)
时间窗: 12 weeks
The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain.
EQ VAS
时间窗: 12 weeks
The EQ-5D VAS is a standardized measure of global health status.
EuroQol five dimensions questionnaire
时间窗: 12 weeks
The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal.
Roles and Maudsley
时间窗: 12 weeks
The RM scale is a subjective 4-point patient assessment of pain and limitations of activity. The RM score has been used extensively at centers throughout the world to assess outcome after SWT.
次要结局
- Likert scale(12 weeks)