研究疾病:
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膝骨关节病
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研究疾病代码:
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Target disease:
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Knee osteoarthritis
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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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本课题拟对手法治疗膝骨关节病进行单中心前瞻性随机对照研究,纳入膝骨关节病病人随机分组、治疗并定期随访,并与非甾体药治疗方案相比较,通过对比研究,验证手法对于膝骨关节病的疗效和优势。
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Objectives of Study:
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This project intends to conduct a single-center prospective randomized controlled study on the treatment of knee osteoarthropathy by manipulation. Patients with knee osteoarthropathy were included in the study, randomly grouped, treated and regularly followed up, and compared with non-steroidal drug treatment, through comparative study, the efficacy and advantages of manipulation for knee osteoarthropathy were verified.
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药物成份或治疗方案详述:
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试验组:手法治疗。
1.患者采用俯卧位,于健肢同侧腰背部进行肘推法放松2~3分钟,然后进行患侧下肢后方肌群放松,松解至足底筋膜;
2.患者取仰卧位,先于患肢内、外侧行擦法各30秒,外侧向上延伸至股骨大转子,内侧向上延伸至腹股沟下5cm处。后于患肢外侧于髂胫束附着点开始按照由下往上至股骨大转子弹拨肌肉结节点,内侧于内收肌起点、腹股沟下5cm处由上往下至内收肌止点,松解股四头肌内、外侧头及内外侧副韧带,按方向内外侧各弹拨2~3分钟;
3.用双手拇指与食指抓拿髌骨,着重将其最大限度向内侧推移,反复内外侧推移5次以松解筋肉、通络止痛。增加髌骨活动度,松解髌周韧带;
4.使患者膝关节先处于自然伸直位,行拔伸牵引法。治疗者双手握持小腿近端,保持向远端牵拉力,缓慢屈曲,再缓慢伸直,一个来回牵引时间5s左右,重复8次,扩大关节前间隙,松解后方关节囊,纠正关节筋肉;
5.最后予膝关节内外侧擦法2~3分钟结束手法治疗。注:手法治疗频率为一周三次,每次治疗间隔一天。
对照组:
1.塞来昔布(0.2g,qd,po);
2.奥美拉唑(20mg,qd,po)。
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Description for medicine or protocol of treatment in detail:
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Test group: Manipulation therapy.
1.The patient was in the prone position, and the elbow was pushed on the ipsilateral lumbar back of the healthy limb to relax for 2-3 minutes, and then the posterior muscles of the lower limb of the affected side were relaxed and loosened to the plantar fascia.
2.The patient was placed in the supine position, and the lateral and inner sides of the affected limb were rubbed 30 seconds before each other. The lateral side extended upward to the greater trochanter of the femur and the medial side extended upward to 5cm below the groin.Then, starting from the iliotibial band attachment point on the outside of the affected limb, the abductor muscle nodules of the greater trochanter of the femur were removed from the bottom to the nodules of the greater trochanter of the femur, and the medial muscle nodules were removed from the starting point of the adductor muscle and 5cm below the groin from the top to the insertion point of the adductor muscle. The quadriceps femoris, the lateral head and the medial and lateral collateral ligaments were released, and the medial and lateral ligaments were plunged 2 ~3 minutes in each direction.
3.With both hands thumb and index finger to grasp the patella, focusing on its maximum to the inside, repeatedly inside and outside the move 5 times to relax muscles, meridians and pain relief.Increase patella mobility and release the peripatellar ductile band.
4.Make the patient's knee joint in the natural extension position first, and perform the method of drawing and extension traction.The healer held the proximal leg with both hands, maintained the distal pulling force, slowly flexed, and then slowly straighten. The pulling time was about 5s, repeated 8 times, enlarged the anterior joint space, released the posterior joint capsule, and corrected the joint muscles.
5.Finally, the medial and lateral rubbing of the knee joint was performed for 2~3 minutes.Note: The frequency of manual treatment is three times a week, with one day interval between each treatment.
Control group :
1.Celecoxib (0.2g, qd, Po);
2.Omeprazole (20mg, qd, Po).
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纳入标准:
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1.符合膝骨性关节炎诊断标准:美国风湿病学会1995年膝骨关节病诊断标准;
2.分级标准:参照Kellgren和Lawrence(K-L)影像分级方法:II-IV;
3.符合膝骨关节炎临床分期中的初期、早期、中期;
4.年龄40-80岁的男性或女性;
5.自愿作为受试对象,签署知情同意书,并能接受治疗。
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Inclusion criteria
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1.Meet the diagnostic criteria for knee osteoarthritis: American College of Rheumatology 1995 diagnostic criteria for knee osteoarthropathy;
2.Grading criteria: According to Kellgren and Lawrence (K-L) image grading method: II-IV;
3.It conforms to the initial, early and middle stages of the clinical stages of knee osteoarthritis;
4.Male or female aged 40 to 80 years;
5.Voluntarily as the subject, sign the informed consent, and can receive treatment.
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排除标准:
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1.合并有严重心血管、肝、肾和造血系统、内分泌系统、恶性肿瘤、消化系统,如消化道溃疡或出血等严重原发性疾病以及精神病患者;
2.病发病影响到关节者,如类风湿关节炎、化脓性骨关节炎、骨肿瘤、结核病、牛皮廯、梅毒性神经病、褐黄病、代谢性骨病、创伤性关节炎、痛风性关节炎、大骨节病等;
3.妊娠期及哺乳期妇女;
4.就诊时有急性并发症的患者;
5.合并有腰椎间盘突出症、腰椎椎管狭窄症且目前症状明显的患者;
6.磺胺类药物、护胃药过敏的患者;
7.手法治疗区域有皮肤病或皮损者;
8.正在参与其他临床试验者。
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Exclusion criteria:
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1.Patients with severe primary diseases of cardiovascular, liver, kidney and hematopoietic system, endocrine system, malignant tumor, digestive system, such as gastrointestinal ulcer or bleeding, and psychosis;
2.The disease affects the joint, such as rheumatoid arthritis, suppurative osteoarthritis, bone tumor, tuberculosis, psoriasis, psoriasis, brown yelp disease, metabolic bone disease, traumatic arthritis, gout arthritis, Kashin-Beck disease, etc.;
3.Pregnant and lactating women;
4.Patients with acute complications during treatment;
5.Patients with lumbar disc herniation and lumbar spinal stenosis and present obvious symptoms;
6.Patients with allergy to sulfonamides and stomach protectors;
7.Skin diseases or lesions in the treatment area;
8.Participating in other clinical trials.
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研究实施时间:
Study execute time:
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从From
2021-07-31
至To
2022-09-01
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征募观察对象时间:
Recruiting time:
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从From
2021-07-31
至To
2022-08-01
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