【ChiCTR2000033581】Short-term effects of ultrasound-guided dry needling on pain and functional disability for osteoarthritis knees: A randomized, double-blinded and controlled trial

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基本信息

登记号

ChiCTR2000033581

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-06-06

临床申请受理号

靶点

适应症

Osteoarthritis knee

试验通俗题目

Short-term effects of ultrasound-guided dry needling on pain and functional disability for osteoarthritis knees: A randomized, double-blinded and controlled trial

试验专业题目

Short-term effects of ultrasound-guided dry needling on pain and functional disability for osteoarthritis knees: A randomized, double-blinded and controlled trial

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

852

联系人通讯地址

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临床试验信息

试验目的

The current study aims to investigate the effects of ultrasound-guided dry needling on KOA patients using a comprehensive evaluation including pain level and functional ability (in addition to exercise therapy prescribed). The findings to be obtained from this study will have a great potential to help the rehabilitation of KOA patients in an efficient and safe manner. If ultrasound-guided needling can enhance the effectiveness of dry needling with exercise in improving pain and functional ability in elderly people with KOA, it is potentially help to reduce burden of total knee replacement operations to public hospitals and mortality rate. It can be potential help to release the stress of elderly patients onto the public healthcare system and to cope with the demands from the aging population in the coming future.

试验分类

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试验类型

随机抽样

试验分期

其它

随机化

All the subjects meet the inclusion criteria will be allocated by computer randomized program that will be created by a statistician who is not otherwise involved in the trial and does not participate in analysis or interpretation of the results.

盲法

The assessor will be blinded to the patients treatment group assignment at all time and will carry all the baseline, 4-week and 8-week evaluations.

试验项目经费来源

N/A

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-07-01

试验终止时间

2022-06-30

是否属于一致性

入选标准

Inclusion criteria with reference to the American College of Rheumatology clinical criteria developed by Altman et al., 1986 (Altman et al., 1986): 1) aged >50 to 80 years old; 2) referred with diagnosed KOA; 3) with episode of anterior and/or medial knee pain at 2-3 local tender spots, crepitus, and functional limitations caused by KOA a period of at least 6 months; 4) stiffness <30 minutes; 5) KL scale (Petersoon et al., 1997) grade I and grade III and , valgus angle of tibiofemoral joint less than 150; 6) able to read Chinese and listen to Cantonese as the outcomes questionnaire is Chinese version and supervised exercise class will be conducted in Cantonese.；

排除标准

1) having other musculoskeletal diseases associated with knee pain e.g. refer pain from LBP or posterior or lateral knee pain or co-existing pain over the other limb; 2) suffering from acute inflammation, diffuse tenderness upon palpation test, bone marrow lesion, severe joint deformity or valgus angle of tibiofemoral joint equal to or more than 150 with XR showed grade IV in KL scale, coagulation disorders, metabolic , or neuropathic arthropathies, immunosuppressed diseases, systematic disease; 3) having severe concomitant illness (e.g. sprain ankle, OA hip, etc.) that may affect the clinical outcomes of this study (e.g. functional mobility); 4) contraindications to dry needling including pregnancy, malignancy, menstruating at the time of study, fear to dry needling; 5) having recent treatment from any acupuncture therapy or dry needling therapy in the previous 2 weeks; 6) cognitive impairment; 7) having wound or pressure sore or skin problems or skin allergy, iodine allergy; 8) having steroid injection or drugs.；

研究者信息

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试验机构

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研究负责人邮箱

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研究负责人邮编

852

联系人通讯地址