Efficacy of Soothing Cream Jel in Improving the Range of Motion and Chronic Pain at Shoulder and Elbow: A Double-blinded, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of the range of motion
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled clinical trial. This trial is used to evaluate the efficacy of soothing cream jel on chronic upper limb pain and the range of motion.
详细描述
Potential subjects will be screened according to the eligibility criteria after signing the informed consent form. Subjects who fulfill the requirements will be randomized into either the treatment group or the placebo group. And receive either soothing cream jel or placebo cream jel for 2 weeks. Then followed by a post-treatment for 2 weeks.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participates in regular physical activity, at least once a week for 30 minutes;
- •Chronic pain in the shoulder or elbow longer than 3 months;
- •11-items Numeric pain rating scale ≥4; and
- •Willing to provide written informed consent.
排除标准
- •The patient had received previous physiotherapy, acupuncture, Tui Na massage, or bone-setting treatment for distal upper limb pain within the past 2 weeks;
- •The pain was due to a fracture or known complex regional pain syndrome.
- •History of upper limb surgery;
- •Known severe medical conditions (e.g. rheumatoid arthritis, osteoporosis, cardiac, renal, hepatic, hematological diseases, vertigo, seizure, infection, malignancy, neurological impairment);
- •Concomitant drugs of NSAIDs, any kind of painkillers, or anti-inflammatory drugs 15 days prior to randomization;
- •Known impaired hematological profile and liver / renal function;
- •Known allergic history to any topical cream;
- •Known pregnant or lactating; or
- •Unable to complete questionnaires
研究组 & 干预措施
Active treatment (Soothing cream jel)
Soothing cream jel
干预措施: SJC (Drug)
Placebo
Placebo cream jel
干预措施: Placebo (Other)
结局指标
主要结局
Change of the range of motion
时间窗: From baseline to week 2
The range of motion of upper (shoulder or elbow) will be measured by a digital goniometer. For the shoulder, active flexion and abduction ROMs are measured using a goniometer while the participants are standing. For the elbow, both flexion and extension will be measured by a goniometer in a standing position.
次要结局
- Chang of the range of motion(From baseline to week 4)
- Change of Numeric pain rating scale (NPRS)(4 weeks)
- Handgrip strength(4 weeks)
- Back-scratch test(4 weeks)
- Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S)(4 weeks)
- Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E)(4 weeks)
- Rescue drugs or treatments used for pain symptoms(From baseline to week 4)
- Score change of 36-Item Short Form Survey (SF-36v2)(4 weeks)
- Change of Numeric pain rating scale (NPRS)(2 weeks)
- Handgrip strength(2 weeks)
- Back-scratch test(2 weeks)
- Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S)(2 weeks)
- Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E)(2 weeks)
- Score change of 36-Item Short Form Survey (SF-36v2)(2 weeks)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong