Efficacy and Safety of Selected Traditional Chinese Medicine Elbow Manipulation Versus Mill's Manipulation as Control for Lateral Epicondylitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient Related Tennis Elbow Evaluation (PRTEE)
研究概览
简要总结
Background: Lateral epicondylitis (LE), also referred to as lateral elbow tendinopathy and tennis elbow, is commonly seen clinically as an orthopedic disease. Joint manipulations is a common LE treatment, which mainly decrease pain and increases range of motion (ROM). This greatly improve the quality of life of LE patients. The selected Traditional Chinese Medicine (TCM) manipulation is created by Prof. Ng Zhong Neng and clinically used in treating LE for more than 20 years. To date, there is no statistical demonstration regarding the safety and effectiveness of this technique. Consequently, this clinical trial is designed to provide the first systematic evaluation of the technique's efficacy and safety.
Objective: To evaluate the efficacy and safety of selected TCM elbow manipulation in treating LE.
Methods: A clinical trial will enroll 40 eligible patients diagnosed with LE who meet the inclusion criteria. They will be randomized into two groups, having 20 participants in each group. Group A will receive an exercise program and a manipulation treatment of Mill's manipulation. Meanwhile, Group B will receive the same exercise program and the selected TCM manipulation. Patient Related Tennis Elbow Evaluation (PRTEE), ROM of wrist and forearm, and pain free grip strength (PFGS) of the affected elbow will be evaluated at the beginning and after the last of intervention in this clinical trial. Treatment effect and sequence effect will be analyze with a linear-mixed effect model by Jamovi (2.7.17).
详细描述
- Trial objectives
This randomized control trial has one main objective, as shown below:
To evaluate the efficacy and safety of selected TCM elbow manipulation in treating LE. 2. Plan of investigation 2.1 Study Design A randomized, controlled, single-blinded and parallel-group design will be used in this study. A total of 40 eligible patients will be recruited immediately after screening. They will be hence allocated into Group A and Group B randomly. The allocation ratio of Group A: Group B is 1:1 respectively. Figure 1 shows the flow chart of this design. Right after the screening, eligible patients was assigned at random to groups A or B in a 1:1 ratio, where they receive exercise with Mill's manipulation or exercise with selected TCM manipulation for 4 weeks. Patient Related Tennis Elbow Evaluation (PRTEE), ROM of wrist and forearm, and pain free grip strength (PFGS) of the affected elbow will be evaluated at the beginning and after the last of intervention in this clinical trial.
2.1.1 Randomization and concealment An allocation of 1:1 will be used in this study in respective of the treatment and control group. Sealed Envelope, an online software which is specifically made for patient randomization of clinical trials, will be used. A blocked randomization list will be generated, separating patients into either the intervention or the control group. The hard copy of the list will be securely sealed inside oblique envelopes, while the soft copy will be protected with password.
2.1.2 Blindness This study adopted double-blinding method. Participants are blinded with allocation concealment to minimize selection bias. All participants will receive a package of exercise and treatment, either Mill's manipulation or selected TCM manipulation, as their intervention. Principal investigator (PI) will illustrate the study procedures and briefly explain the usage of the manipulations without disclosing any treatment information to the participants. To further access the effectiveness of blinding, James and Bang blinding index will be used, which are standard measures to evaluate blinding in randomized control trials. To minimize any potential bias, the outcome assessor and data analyst will be blinded to the allocation list.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、研究者、结局评估者)
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
- 是
入选标准
- Tenderness was elicited over the lateral epicondyle, extending 2-3 centimeters distal to it over the ECRB and extensor digitorum tendons.
- Pain in lateral elbow with resisted extension of wrist and middle finger
- Pain in lateral elbow with forceful grasp
- Normal ROM of elbow
- Pain reproduced with resisted isometric contraction of wrist extensors during loaded test
- Absence of numbness and tingling at forearm, hand and fingers
- Absence of neck pain and stiffness
- Age 18 to 65
- Pain duration of more than 4 weeks with local tenderness near the lateral epicondyle
- Obtain a positive result in either Cozens Test or Mills' Test.
排除标准
- Patients that are pregnant and lactating
- Had any form of administration of non-steroidal inflammatory drugs during the past two weeks
- Had received steroid injections during the past two months
- Patients with severe comorbidities, for example, poorly regulated Diabetes Mellitus, coagulopathy, goiter, liver-kidney disease, acute-chronic inflammation and any malignancies
- Infected or ulcerated skin around the lateral epicondylitis
- Had received any physical therapy treatment during the past two months
- Had received acupuncture during the past two weeks
- History of elbow surgery, fracture (distal humerus fracture, olecranon fractures and radial head and neck fractures), dislocation, infection, inflammation, tumor, rapidly progressive neurological deficit, neurovascular compromised and compartment syndrome
- Presence of osteoporosis
研究组 & 干预措施
Group A: Treatment with Selected TCM manipulation
Selected TCM manipulation for LE will be perform with internal rotation of the humerus, shoulder abduction, full elbow extension, and neutral position forearm and wrist. The practitioner will stabilized the wrist of the patient with one hand and the humerus with another hand. An medial inversion with a high velocity and low amplitude thrust will be done towards the downward position of the patient.
The above manipulation will be done for group B patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho. We have obtained a professional consultation from Mr. Chiu Wai Shun, a senior physiotherapist with 20 years of clinical practice. Mr. Chiu evaluated and approved Dr. Chow's method of performing the Mills manipulation for this trial.
干预措施: Selected Traditional Chinese Medicine manipulation (Other)
Group B: Treatment with Mill's Manipulation as the control
Mill's manipulation will be performed with a sitting position of the patient. The affected extremity positioned 90∘ abduction with internal rotation of the humerus, forearm pronation and wrist flexion, which will be stabilized by the practitioner. The olecranon should face upward in this position. The practitioner should stabilize the patients shoulder and holding the olecranon with the another hand. A high velocity, low-amplitude thrust will be applied at the end of full extension of the elbow.
The above manipulation will be done for group A patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho.
干预措施: Mill's Manipulation (Other)
结局指标
主要结局
Patient Related Tennis Elbow Evaluation (PRTEE)
时间窗: Baseline, week 4
PTREE involved 15 items which is self-reported by the patient, in order to measure their perceived pain and disability. There are three aspects in the questionnaire, including pain with 5 items, difficulty in performing usual activities with 6 items and difficulties in performing specific activities with 4 items. For each item, a scale of 1 to 10 can be chosen, hence the total score has a range of 1 to 100. Higher score indicates higher level of disability. Other than the English version of PRTEE, a recognized Chinese translated version will also be used to facilitate the responds of Chinese-speaking participants.
次要结局
- Range of Motion measurement(Baseline, week 4)
- Pain Free Grip Force (PFGS) measurement(Baseline, week 4)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07843771
- 其他研究编号
- REC/25-26/0404
日期
- 首次提交
- (14天前)
- 首次发布
- (前天)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (3个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否