Efficacy of Dry Needling With the Fascial Winding Technique in the Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- The need to continue performing surgery for carpal tunnel syndrome.
研究概览
简要总结
So far there are studies that report the benefits of physiotherapy treatment in carpal tunnel syndrome, but none on the treatment of dry needling. Recently, an ultrasound validation study has been published in which the results indicate that the application of dry needling with "fascial winding technique" in the carpal tunnel, following the "four-pole carpal dry needling" model, is valid for reaching and traction of the transverse carpal ligament. Stretching over this ligament could lead to new therapeutic possibilities for dry needling at this level. The objective of this project is to demonstrate the clinical efficacy of this technique in patients affected by carpal tunnel syndrome, determining the proportion of patients who can be avoided surgery, and quantifying the improvement in the clinic related to pain, strength and functionality of the hand and the median nerve.
The study is a randomized clinical trial on a sample of 86 patients diagnosed with carpal tunnel syndrome, who have been prescribed surgery at this level. The degree of involvement of the median nerve will be mild or moderate, according to electromyographic results. The dry needling with fascial winding technique will be applied to the intervention group following the model of "four-pole carpal dry needling" during a period of 6 weeks, at the rate of one weekly session. The control group will remain within the normal course of their waiting list status for STC surgery, without receiving any extraordinary treatment to what is normally practiced in this situation. The main variables contemplated are: need for surgery at the end of the study, level of involvement of the median nerve (according to electromyographic result), transverse area of the median nerve at the entrance of the carpal tunnel and relationship between the area of the median nerve at the wrist and the forearm (both recorded by ultrasound study), pain intensity (using visual analog scale), symptom intensity, functional capacity and quality of life (according to the Boston Carpal Tunnel Questionnaire), and degree of muscular strength to the grip manual and digital.
详细描述
INTRODUCTION:
Dry Needling (DN) is an invasive technique widely used in the Physiotherapy field, on which numerous studies have recently been published. The vast majority of these studies focus on the action of DN on the muscular element: the well-known myofascial trigger points. According to what Dunning proposed in 2014, it should not ignore and/or underestimate its action on the connective-fascial tissue, the other aspect of a single, unique and indivisible functional whole: the myofascia.
In the field of acupuncture, numerous studies have been conducted to determine the role played by the fascia in the therapeutic phenomenon that begins when working with a needle. Among these, mention in particular the studies of Dr. H. M. Langevin, pioneers in the contribution of scientific evidence to the phenomenon known as "needlegrasp". When the acupuncture needle (the same as the one used in DN) is rotated, the fascial connective tissue winds around to the point where it is fastened and trapped.
With the intention of demonstrating the benefit of treatment with DN on connective-fascial tissue, the investigators present this research project. In the same, it is proposed to apply DN in a pathology such as carpal tunnel syndrome (CTS), in which surgical treatment is currently considered principally.
There are previous studies that describe the benefits of physiotherapy treatment in the CTS, but none on the treatment of DN. Recently, it has been validated using ultrasound image how DN needles, applied following the original model proposed and described as "four-pole carpal dry needling" (FCDN), reach the transverse carpal ligament (TCL) in 93.1%. In turn, if these needles are manipulated in the form of unidirectional rotation, named in this work as "fascial winding technique" (FWT), a traction-stretching of this ligament can be observed via ultrasound. It was possible to observe in 80.6% of the occasions. The results obtained indicate that DN with FWT in the carpal tunnel (CT), following the FCDN model, is valid to reach and traction the TCL. Similarly, the same study also shows this treatment as safe in terms of not injuring the median nerve and/or the ulnar artery. The level of pain and/or superficial bleeding produced is very slight and only at the time of performing the technique, without causing painful discomfort or residual bruising.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Assignment to groups. To the extent that the sample is recruited, subjects will be randomly distributed into two groups (intervention and control) using a software-generated randomization system. Each subject will be assigned a numbered, sealed and opaque envelope where their inclusion in the intervention or control group will be specified.
The evaluating staff will be blinded to the assignment to the groups.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population are individuals with a clinical and electromyographic diagnosis of CTS, and levels of mild median nerve involvement (focal demyelination without axonal degeneration) or moderate (focal demyelination with sensory but non-motor axonal degeneration) according to electromyogram (EMG).
排除标准
- •Will not be included those subjects with previous surgery in the CT, to whom the involvement of the median nerve is attributable to another type of neuropathy (diabetic, uraemic, deficiency, ...), to those who present a previous pain in the region, attributable to arthritis and not to CTS, to individuals suffering from fibromyalgia and/or chronic pain syndrome, to those who suffer from aversion or phobia to needles, to pregnant patients, to those with intellectual disability to understand the procedure, methodology and object of the study (mental, psychiatric disorders, low level of IQ, ...), and/or those patients who show little collaboration to the correct performance of the study.
结局指标
主要结局
The need to continue performing surgery for carpal tunnel syndrome.
时间窗: Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study
According to the tests carried out and under medical criteria, at the end of the study will be assessed the need to continue performing surgery at this level for each of the individuals who participated in the study.
次要结局
- Level of involvement of the median nerve, registered by EMG.(Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study)
- Muscular strength to manual and digital grasping.(For Intervention group: Before the start of treatment (week 0), every two weeks (weeks 2, 4, 6 and 8) and after 6 weeks of the end of treatment (week 12). For Control group: week 0, week 6 and wek 12)
- Wrist-forearm relationship (WF-R)(Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study)
- Cross sectional area of the median nerve at the wrist tunnel (CSA-M)(Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study)
- Boston Carpal Tunnel Questionare (BCTQ)(For Intervention group: Before the start of treatment (week 0), every two weeks (weeks 2, 4, 6 and 8) and after 6 weeks of the end of treatment (week 12). For Control group: week 0, week 6 and wek 12)
- Intensity of pain, collected and measured with a Visual Analogue Scale (VAS).(For Intervention group: Before the start of treatment (week 0), every two weeks (weeks 2, 4, 6 and 8) and after 6 weeks of the end of treatment (week 12). For Control group: week 0, week 6 and wek 12)
- Visual Analogue Scale (VAS) for Intensity of pain caused by the Four Carpal Dry Needling (FCDN) approach model.(Only in the Intervention group: in the weeks 2, 4 and 6.)
- Positive Clinical Diagnosis of CTS(Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study)
- Adverse or unwanted effects.(Only in the Intervention group: in the weeks 2, 4, 6 , 8 and 12.)
研究者
Jordi Gascon-Garcia
Principal Investigator
Universitat Internacional de Catalunya