研究疾病:
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慢性非特异性腰痛
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研究疾病代码:
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Target disease:
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Chronic nonspecific low back pain(CNLBP)
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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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治疗新技术临床试验
New Treatment Measure Clinical Study
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研究目的:
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根据CNLBP受试者核心肌群的表面肌电特征,提炼针对腰痛康复优化的八段锦动作要素,编制优化版八段锦,验证优化版八段锦相对体育总局版八段锦的优效性,实现优化版八段锦对CNLBP的精准康复。
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Objectives of Study:
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According to the surface electromyography characteristics of the core muscle group of CNLBP subjects, the action elements of baduanjin optimized for low back pain rehabilitation were refined, and the optimized version of baduanjin was compiled, and the efficacy of the optimized version of baduanjin compared to the eight-danjin of the General Administration of Sports was verified, so as to realize the accurate rehabilitation of the optimized version of baduanjin to CNLBP.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1.临床诊断标准:
①发病部位疼痛,多为酸痛不适,肌肉僵硬板滞,或有重压感、下坠感,腰部发沉。晨起或天气变化及受凉后症状加重,活动后则疼痛减轻,常反复发作。弯腰工作困难,弯腰稍久则疼痛加重,常喜用双手捶腰,以减轻疼痛。
②查体:腰部外形多无异常,俯仰活动多无障碍。有时可触及肌筋膜紧张,少数患者腰部活动稍受限并有压痛,压痛部位多在骶棘肌处、骶骨后面骶棘肌止点处,或髂骨嵴后部、腰椎横突部、棘突间隙或者棘上韧带处。
③持续性或间歇性腰痛时间超过3个月;
④必要的影像学检查(X-ray、CT、MRI)及生化检查,用于除外肿瘤、感染或骨折及其它原因引起的腰背痛。
纳入标准:
①18岁≤年龄≤70岁;
②符合慢性非特异性腰痛诊断标准且疼痛强度VAS≤3分;
③智力正常,能正常沟通交流和理解量表。
④受试者愿意参加本试验,并签署知情同意书。
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Inclusion criteria
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1. Clinical diagnostic criteria:
(1) Pain at the site of onset, mostly soreness and discomfort, muscle stiffness and stagnation, or a sense of heavy pressure, falling, waist sinking. Symptoms worsen in the morning or after weather changes and colds, but the pain is reduced after activity, and often recurrent attacks. Bending down to work is difficult, bending over a little longer will aggravate the pain, often like to use both hands to beat the waist to reduce the pain.
(2) Physical examination: there is no abnormality in the shape of the waist, and the pitching activity is more barrier-free. Sometimes the muscular fascia is tight, and a few patients have a slightly limited lumbar movement and tenderness, mostly at the sacral spinous muscle, at the sacral spinous muscle stop point behind the sacrum, or at the posterior part of the iliac crest, the lumbar transverse process, the space between the spines, or the supracanthin ligament.
(3) Persistent or intermittent low back pain for more than 3 months;
(4) Necessary imaging tests (X-ray, CT, MRI) and biochemical tests to exclude tumors, infections, fractures, and other causes of low back pain.
Inclusion criteria:
(1) 18 years old≤ age ≤70 years;
(2) VAS ≤3 points for pain intensity that meets the diagnostic criteria for chronic nonspecific low back pain;
(3) Normal intelligence, able to communicate and understand the scale normally.
(4) Subjects are willing to participate in this test and sign an informed consent form.
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排除标准:
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①严重的肺心脑血管疾病;
②疑有或已确诊的严重脊柱病理(脊柱骨折、肿瘤、炎症或感染性疾病、马尾综合征、弥漫性神经系统性疾病、结核及严重骨质疏松者等);
③接受过或计划在研究期间进行脊柱相关大手术治疗,或严重腰椎先天畸形者;
④妊娠或哺乳期妇女;
⑥腰部以外疼痛更严重;
⑦过敏体质者,患有出血倾向、皮肤破损、传染性疾病者;
⑧体内含有磁性金属植入物,影响MRI检查者。
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Exclusion criteria:
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(1) Severe pulmonary cardiovascular and cerebrovascular diseases;
(2) suspected or confirmed serious spinal pathology (spinal fractures, tumors, inflammatory or infectious diseases, horsetail syndrome, diffuse nervous system diseases, tuberculosis and severe osteoporosis, etc.);
(3) people who have received or planned to undergo spinal-related major surgery during the research period, or severe congenital deformities of the lumbar spine;
(4) pregnant or lactating women;
(6) pain outside the waist is more serious;
(7) people with allergic constitutions, suffering from bleeding tendencies, skin damage, infectious diseases
(8) The body contains magnetic metal implants, which affects MRI examiners.
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研究实施时间:
Study execute time:
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从From
2021-07-01
至To
2024-06-30
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征募观察对象时间:
Recruiting time:
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从From
2022-07-01
至To
2023-12-30
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