【ChiCTR2000039318】Comparison of diclofenac with tramadol, tizanidine or placebo in the treatment of acute low back pain: multi-centre randomised controlled trial

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基本信息

登记号

ChiCTR2000039318

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2020-10-23

临床申请受理号

靶点

适应症

adults aged from 18-65 with acute non-specific low back pain

试验通俗题目

Comparison of diclofenac with tramadol, tizanidine or placebo in the treatment of acute low back pain: multi-centre randomised controlled trial

试验专业题目

Comparison of diclofenac with tramadol, tizanidine or placebo in the treatment of acute low back pain: multi-centre randomised controlled trial

申办单位信息

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临床试验信息

试验目的

To compare the efficacy of the combination of NSAID with tramadol, tizanidine or placebo in improving functional outcome using the primary outcome measure namely RMDQ scores at one week. To investigate the efficacy of these drugs and documenting the changes in the functional outcome, pain intensity score and total loss of work period up to four weeks. To document the side effect profile and the compliance of these drugs in the Hong Kong Chinese population, and understand the further need for pain medications for up to four weeks.

试验分类

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

A stratified randomisation technique will be used to ensure that subject s from all three EDs are allocated to equal proportions for the three treatment arms. Sequence generation using random numbers generated from SPSS will be used, with a block size of 12 with four in each arm.

盲法

The research nurse/assistant, treating physicians, subjects and outcome assessor will be blinded to the allocation.

试验项目经费来源

Health and Medical Research Fund

试验范围

目标入组人数

123

实际入组人数

第一例入组时间

2020-10-21

试验终止时间

2023-10-20

是否属于一致性

入选标准

Patients aged from 18 to 65 attending the participating EDs from 9am to 4pm on weekdays for non-specific low back pain, as defined by pain between the twelfth rib and the crease of the buttocks. Patients with sciatica and radicular pain will be included, except those of traumatic in-origin (direct trauma to the back) or those with identified red flag signs for significant pathologies. These patients normally are managed by clinicians within the emergency department, and the emergency medicine ward (EMW) if symptoms are severe. We will recruit patients with a score greater than five on the RMDQ, as previous studies have suggested that the minimal clinically important difference to be five. By recruiting this group of patients, we exclude those expected to resolve no matter if or which analgesics are given.；

排除标准

Patients will be excluded if they are non-Chinese in ethnicity, if they present with LBP of more than four weeks in origin or LBP caused by direct trauma. Patients suspected to have conditions other than non-specific acute LBP, including those with red flag signs and symptoms, and those to be admitted to wards other than EMW or those who require operative treatment. Patients who have a RMDQ less than five at baseline, or those who have been given analgesic drugs outside of the protocol in the same ED visit. Pregnant patients, those taking oral contraceptive pills or those who are contraindicated to one or more of the drugs including active gastrointestinal symptoms, renal insufficiency with serum creatinine >150 umol/L, bleeding disorder, on warfarin or other anticoagulants (patients on antiplatelet drugs is not an exclusion criteria, unless deemed unfit by treating clinician), those with known allergy or with significant drug interaction. Those who are not able for follow up, including those without a telephone contact, or with significant co-morbidity which could interfere with assessments, including confusion or dementia will also be excluded. Patients holding a US or Canadian passport will also be excluded following the policy of the clinical trial insurance. Patients will be advised not to receive oral herbal treatment simultaneously, as there maybe potential interaction of the ingredients. If patients wish to continue oral herbal treatment during the trial period, then they will be excluded from the study.；

研究者信息

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试验机构

中國香港特別行政區食物及衞生局

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