A Randomized Double-blind Study to Assess the Use of TDP© Heat-lamp as an Effective Therapy for Tennis Elbow Pain (Lateral Epicondylitis Pain)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- To determine if TDP© heat lamp is an effective therapy for the alleviation of chronic pain due to lateral epicondylitis (tennis-elbow pain.)
研究概览
简要总结
Tennis elbow (Lateral epicondylitis) is a common condition seen in Family Medicine that gives rise to pain, and can lead to loss of function and time off work.
The normal treatment for tennis elbow pain is oral pain relief medication (analgesia), and/or physiotherapy, local massage or even surgery. In mainland China, tennis elbow pain has also been treated using TDP © Heat-lamp therapy, and is considered to be an effective treatment for this condition.
This study is a clinical trial that seeks to measure the effectiveness of the TDP © Heat-lamp therapy to relieve tennis elbow pain without the use of oral pain medication.
详细描述
Double-blind randomized controlled trial
Patient recruitment
Patients registered in the Electronic Medical Record (EMR) system of the Family Medicine Centre of Queen's University with a confirmed diagnosis of tennis elbow (lateral epicondylitis) in the 12-month period from 1st March 2008 to 31st March 2009, are recruited and studied. An internal email plus paper memo will be circulated to all other Family Physicians in the Centre, requesting their participation in the study. Patients are then selected randomly from the pool.
Entry/Randomization Procedure
All eligible patients enrolled in the study centre will be entered into a patient registration log. This will automatically provide a serial number for that patient that should be used for all documentation and correspondence about this patient. All randomizations will be done centrally by the administrator at the CSPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that have consented.
- •Patients diagnosed with tennis elbow pain. Definition of tennis elbow (lateral epicondylitis) is "pain or tenderness on loading relevant muscle on the lateral epicondyle, with no shoulder or wrist pain.". Patients recruited will be interviewed and examined to confirm the clinical diagnosis. The level of pain will be assessed with the visual analogue scale (VAS) and level of functional disability with the QUICKDASH Questionnaire.
- •Patients must be between the ages of 18-65.
排除标准
- •Patients with existing diagnosis of neuropathic pain, metabolic or metastatic bone pain will be excluded. So will patients with recent or previous bone fracture of the elbow and epicondyles.
- •Patients taking any form of oral analgesia in the last 2 weeks prior to randomization.
结局指标
主要结局
To determine if TDP© heat lamp is an effective therapy for the alleviation of chronic pain due to lateral epicondylitis (tennis-elbow pain.)
时间窗: At completion of trial
次要结局
未报告次要终点
研究者
Jyoti Kotecha
Assistand Director
Queen's University