NCT00792376已完成4 期
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Argentine Tennis Association1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The pre-defined primary efficacy endpoint of the study is a 100-mm pain visual analog scale (P-VAS), where 0= no pain; 100= extreme pain.
研究概览
简要总结
The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness and functional recovery of patients suffering acute Achilles tendinopathy.
It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles tendinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible if they are male between 18 and 50 years of age and they suffer acute Achilles tendinopathy (<2 weeks). Diagnosis of Achilles tendinopathy is made by means of activity-related achillodynia, morning stiffness or pain, painful one-legged jumping test, tenderness and decreased sports performance (26). Subjects' age, race, affected tendon (right, left), activity, height and weight will be recorded.
排除标准
- •Patients are excluded from the study if they have:
- •Prior lower limb surgery or major trauma.
- •Bilateral Achilles tendinopathy.
- •History of lower limb radiculo-neuropathy or miopathy.
- •Hypersensitivity to any NSAIDs.
- •Used analgesic agents (NSAIDs, salicilates, narcotic) within 1 week
- •Concurrent medical/arthritic disease (e.g. gout, lupus, rheumatoid arthritis).
- •Other concurrent medical conditions including diabetes, hypertension, angina or congestive heart failure, ischaemic cardiopathy, malabsorption, morbid - Personal history of renal dysfunction, hepatic dysfunction or anemia
- •Used corticosteroids, clopidogrel bisulphate, rifampin, quinolon antibiotics, antiepileptics, muscle relaxants, warfarin, ticlopidine, glucosamine, condroitin sulphate for < 6 months prior to the study start. Patients taking low dose aspirin (100 mg) for cardioprotective benefit will be also excluded. Any other medication consumption will be considered by the investigator and the Ethical Committee.
- •Any other condition which, in the opinion of the investigator, could confound the study results or pose a risk to the patient (for example, co-morbid conditions for which NSAIDs are contraindicated).
- •History of psychotic illness, dementia or depression
- •History of drug or alcohol abuse or dependence.
- •Participated in any previous NSAIDs study and received active treatment, or in an investigational trial within 30 days prior to the first visit.
- •Inability to communicate or to cooperate with the investigator.
研究组 & 干预措施
etoricoxib
Experimental
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
干预措施: etoricoxib (Drug)
etoricoxib
Experimental
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
干预措施: diclofenac (Drug)
diclofenac
Active Comparator
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
干预措施: diclofenac (Drug)
结局指标
主要结局
The pre-defined primary efficacy endpoint of the study is a 100-mm pain visual analog scale (P-VAS), where 0= no pain; 100= extreme pain.
时间窗: 1 week
次要结局
- The secondary study endpoints includes: the VISA-A Questionnaire, the Achilles Tendinopathy Scoring System (ATSS), PGART using a 5-point Likert scale and leg functional stiffness.(1 week)
研究者
Javier Maquirriain
MD
Argentine Tennis Association
研究点 (1)
Loading locations...
相似试验
终止
2 期
Efficacy of Etoricoxib on Peripheral HyperalgesiaCausalgiaPeripheral Nerve InjuryRadiculopathyPostherpetic NeuralgiaPolyneuropathyNCT01088256Ruhr University of Bochum9
已完成
不适用
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser PhotocoagulationProliferative Diabetic RetinopathyNCT00529594University of Sao Paulo44
Unknown
4 期
Etoricoxib Versus Ibuprofen in Third Molar Extraction PainDental ExtractionNCT00855777Universita di Verona110
Unknown
4 期
Etoricoxib for Postoperative Pain After Thyroid SurgeryAcute PainNCT00935116Hospital Padre Hurtado70
尚未招募
不适用
Effectiveness of Tecar Therapy in Patients With Chronic Achilles TendinopathyAchilles TendinopathyNCT05539586Universitat Internacional de Catalunya50