Study ProtocolFire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial
Introduction
Stroke is ranked as the most common cause of disability and the second most common cause of death [1], with high morbidity, disability rate, fatality rate and recurrence rate in clinical practice [2]. With a 90% probability of occurring about within 3 weeks after stroke, spastic paralysis is considered one of the most common physical and behavioral disorders [3], [4]. Joint convulsion, deformity and muscle atrophy caused by stroke always bring on the clinical symptoms of motor dysfunction, joint swelling, pain and numbness, which will reduce the patient’s quality of life and give a heavy physical, psychological and economic burden to patients, and may lead to loss of labor capacity [5], [6], [7], [8].
Medications such as spasmolysis medicine and neuromuscular blocking agent for upper limb spastic paralysis (ULSP) after stroke are commonly used in contemporary clinical treatment [9]. However, some side effects like cardiac arrhythmia, hyperkalemia and amyostasia, may be caused by these medications. Currently, complementary and alternative medicines, such as acupuncture, are widely used to treat ULSP [10], [11], [12]. Meanwhile, increasing evidence for the efficacy of acupuncture to treat ULSP has been generated through clinical and experimental observations [13], [14], [15].
Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat ULSP after stroke. The fire needles are of different sizes, and made from special materials that have high temperature resistance. The acupoints and possible mechanism of fire-needle acupuncture therapy are similar to filiform needle therapy, but the techniques differ in needle manipulation and retention time [16]. In modern practice fire-needle acupuncture has shown impressive therapeutic outcomes; some clinical experience indicates that fire-needle acupuncture can take less time, require fewer visits, produce effects more quickly, and result in fewer side effects compared with chemical medicine [17], [18], [19]. Although some studies have investigated fire-needle acupuncture for spastic paralysis after stroke and yielded satisfactory results, problems exist in some literature, such as defects in the randomized control method, shortcomings of experimental design and nonstandardized fire-needle technique [20], [21], [22]. Therefore, we have planned a randomized controlled trial to assess the current evidence for the safety and efficacy of fire-needle acupuncture in treating ULSP after stroke.
Section snippets
Study design
This is a randomized, controlled trial, designed to evaluate whether fire-needle acupuncture can improve the quality of life in ULSP, by relieving the spasm and muscular tension of ULSP patients. The study will be conducted in Changhai Hospital of China from July, 2017 to June, 2020.
Ethical considerations and trial registration
This trial has already been approved by the Institutional Review Board (IRB; reference number CHEC2016-107 and CHEC2018-073, IRB at Shanghai Changhai Hospital Ethics Committee, approved on 12 November 2016 and 2
Discussion
Fire-needle acupuncture therapy has been used in clinic settings since ancient times in China [35]. Recent clinical research showed that fire-needle acupuncture therapy was effective for sequela of apoplexy [36], [37], [38]. Further, according to our clinical experience using fire-needle acupuncture to treat sequela of apoplexy, this method has a rapid curative effect, lower treatment frequency and no side effects, compared to other therapies. This makes it more suitable for our fast-paced
Funding
This research is funded by Science and Technology Commission of Shanghai Municipality (No. 17401933900).
Conflict of interests
The authors declare no conflict of interests.
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