研究疾病:
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外侧踝关节扭伤
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研究疾病代码:
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Target disease:
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Lateral ankle sprain
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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比较摇拔戳手法治疗外侧踝关节扭伤治疗前后的步态参数变化,探讨该手法潜在的生物力学作用机制。
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Objectives of Study:
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To compare the changes in gait parameters before and after the treatment of lateral ankle sprain using the rotating-pulling-poking manipulation, and explore the potential bio-mechanical mechanism of this manipulation.
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药物成份或治疗方案详述:
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两组患者皆予以健康宣教:①休息:治疗期间以休息为主,尽量避免剧烈运动;②抬高患肢:使踝关节水平位与心脏齐平或高于心脏,利于消肿;
(1)试验组:摇拔戳手法配合弹力绷带外固定治疗:①摇拔戳手法操作步骤(图1)如下:A)摇晃手法:操作医生两手相对,双手拇指按住外踝下缘,其余四指握住患足,将足踝摇晃转动,连续操作6次;B)拔伸手法:医生与助手进行相对拔伸,并将足跖屈内翻;C)戳按手法:再将足背伸外翻,双手拇指同时向下戳按。每周治疗2次,2周共4次治疗;②弹力绷带加压包扎外固定:采用8字缠绕法,将弹力绷带(规格:宽7.5cm x 长4.5m)从小腿外侧经踝前、足内侧、足底、足外侧缠向踝前、小腿内侧,重复缠绕6~8层。下缘平足底,上缘超内外踝10cm,调整绷带松紧度,保护骨骼突出部位,防止压疮。治疗第一天开始固定,弹力绷带3天一换,连续佩戴2周。
(2)对照组:冰敷配合弹力绷带外固定治疗:①冰敷:准备冰水混合物一袋,冰敷患处,每次15分钟,隔2小时敷1次,一天敷3次,在踝关节扭伤的前3d连续使用。②弹力绷带加压包扎外固定:包扎方法同试验组,治疗第一天开始固定,弹力绷带3天一换,连续佩戴2周。
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Description for medicine or protocol of treatment in detail:
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Both groups of patients were given health education: ① rest: during the treatment period, rest was the main focus, and vigorous exercise should be avoided as much as possible; ② Raising the affected limb: the patients made the ankle joint level with or above the heart, which was beneficial for reducing swelling;
(1)Experimental group: The pantients were treated by rotating-pulling-poking manipulation combined with elastic bandage external fixation treatment: ① rotating-pulling-poking manipulation operation steps (Figure 1) as following: A) rotating manipulation: The doctor operated with two hands facing each other, with both thumbs pressing on the lower edge of the outer ankle, and the other four fingers gripping the affected foot, rotating the ankle for 6 consecutive operations; B) pulling manipulation: The doctor and assistant performed relative pulling, and turned the footpad inward; C) poking manipulation: The doctor and assistant extended the back of the foot and turn it outward, while simultaneously poking and pressing with both thumbs downwards.② Elastic bandage pressure binding and (2)external fixation: The doctor used the 8-shaped wrapping method with the elastic bandage (specification: 7.5cm wide x 4.5m long) from the outer side of the calf, past the front of the ankle, inside of the foot, sole, and outside of the foot, towards the front of the ankle and inside of the calf, to wrap the affected feet repeatedly for 6-8 layers.The lower edge leveled with the sole, and the upper edge exceeded the inner and outer ankles by 10cm. Tightness of the bandage was adjusted to protect the protruding parts of the bone and prevent pressure ulcers. From the first day of treatment, the elastic bandage was fixed for 3 days and replaced every 3 days for 2 consecutive weeks
Control group: The patients were treated by ice compress combined with elastic bandage external fixation treatment: ① Ice compress: The doctor prepared a bag of ice water mixture to compress the affected area for 15 minutes each time, applying once every 2 hours, three times a day.And the treatment was used continuously for the first three days of ankle joint sprain. ② Elastic bandage pressure binding and external fixation: The binding method was the same as that of the experimental group. The fixation started from the first day of treatment, and the elastic bandage was changed every 3 days and worn continuously for 2 weeks[1].
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纳入标准:
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①符合外侧踝关节扭伤诊断标准:有明确的踝关节外伤史,出现踝关节疼痛、肿胀、皮下瘀斑、活动功能受限等症状,有踝关节局部压痛,内翻应力实验阳性等体征;
②MRI检查显示韧带未有Ⅱ度以上撕裂损伤(韧带损伤分级:Ⅰ度损伤:韧带松弛,无明显撕裂;Ⅱ度损伤:韧带部分撕裂;Ⅲ度损伤:韧带完全断裂),内翻应力位X线摄片示距骨倾斜角<15 °且未见骨折、脱位;
③年龄18-60岁;
④VAS评分3-7分;
⑤签署知情同意书者。
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Inclusion criteria
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①All participants met the diagnostic criteria for lateral ankle sprain all participants had a clear history of ankle injury, with symptoms such as ankle pain, swelling, subcutaneous ecchymosis, and limited mobility, as well as signs such as local tenderness of the ankle joint and positive varus stress test;
② MRI examination of the participants showed no degree II or higher tear damage to the ligament (ligament injury grading[16]degree I injury : ligament relaxation without obvious tearing; degreeⅡ injury: partial ligament tear; degree Ⅲ injury: complete ligament rupture), and X-ray imaging of the varus stress position showed a talus inclination angle of<15 ° and no fractures or dislocations;
③ all the participants are 18-60 years old;
④ The VAS scores of all participants were 3-7 points.
⑤ the person who signed the informed consent form.
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排除标准:
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①伴有骨关节感染、骨折、肿瘤、结核等;
②踝关节局部有皮肤破损或皮肤病者;
③有踝关节手术史;
④不适合参与临床研究的特殊人群(盲、聋、哑、智力或精神障碍等);
⑤踝关节韧带Ⅲ度损伤。
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Exclusion criteria:
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① The cases accompanied by bone and joint infections, fractures, tumors, tuberculosis, etc.;
② Individuals with local skin damage or skin disorders in the ankle joint;
③ Individuals with a history of ankle surgery;
④ Special populations who were not suitable for clinical research (blind, deaf, mute, intellectual or mental disorders, etc.).
⑤ third degree ankle ligament injury
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研究实施时间:
Study execute time:
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从From
2022-11-16
至To
2023-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-11-30
至To
2022-12-31
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