Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients a Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- to investigate the effect of magnesium sulfate on pain intensity
研究概览
简要总结
This study is conducted To evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.
详细描述
This study is conducted To evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.
BACKGROUND:
Lateral epicondylitis (LE) (tennis elbow) is a tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use (mostly of the extensor carpi radialis brevis), forced extension or direct trauma in the epicondyle . LE has an approximate rate of 40% and a prevalence of 1-3% of the general population . It mostly affects people 40 years and older. Some studies indicate that men and women are equally affected; others report a higher percentage of affected women .
HYPOTHESES
It will be hypothesized that:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Their age will be ranged between 20-50 years with both gender
- •Pain on the lateral side of the elbow for at least 4 weeks
- •Tenderness over the lateral epicondyle
- •At least two positive provocative tests: Mill test and Thomson test
排除标准
- •• History of injection, surgery, physical therapy in the elbow area in the last 3 months
- •Previous elbow surgery
- •History of radius/ulna fracture
- •History of cervical and shoulder problems
- •Having bilateral symptoms
- •Concomitant medial epicondylitis
- •Malignancy
- •Pregnancy
- •Systemic rheumatologic disease or systemic infection
- •Inserted cardiac pacemaker
- •Presence of coagulation disorders
- •Cognitive dysfunction
研究组 & 干预措施
group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode))
Iontophoresis therapy (MgO4 will be applied to the active positive electrode and the treatment will be repeated twice a week for four weeks) + conventional therapy (Splint + Stretch + strength).
干预措施: Magnesium sulfate (Drug)
group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode))
Iontophoresis therapy (MgO4 will be applied to the active positive electrode and the treatment will be repeated twice a week for four weeks) + conventional therapy (Splint + Stretch + strength).
干预措施: conventional therapy (Other)
Control Group (2): conventional physical therapy treatment
conventional therapy (Splint + Stretch + strength) twice a week for six weeks
干预措施: conventional therapy (Other)
结局指标
主要结局
to investigate the effect of magnesium sulfate on pain intensity
时间窗: 6 weeks
. Visual analogue scale will be used to assess the pain intensity level. Pain intensity Level will be measured using the VAS that consists of a 10-cm straight line with endpoints defining pain intensity.All patients will be asked to mark their pain level that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain imaginable". The distance between "0" and the mark made by the patients was measured. Difference in pain intensity will be recorded at rest, at night, and during activity (repeated elbow movement) at baseline and after treatment
investigate the effect of magnesium sulfate on muscle power in patients with lateral epicondylitis.
时间窗: 6 weeks
Cyriax Resisted Muscle Test: In this test, the patients will be seated and positioned with their upper extremities relaxed. The test will include elbow extension, third finger extension, pronation, and supination. All tests were conducted in a standardized manner using maximal isometric resistance and allowing no movement at either joint. Based on manual muscle testing principles, the examiner will hold the contraction for approximately 3 s to allow the patients time to build to maximum tension. The examiner will stabilize the patients' elbows with one hand and applied resistance with other hand. The patients will be instructed to report the onset of or an increase in pain. The results of the resisted tests will be recorded as "strong and painless", "strong and painful", "weak and painful", and "weak and painless". The Cyriax Resisted Muscle Test was conducted at baseline and after treatment
investigate the effect of magnesium sulfate on hand grip in patients with lateral epicondylitis.
时间窗: 6 weeks
Maximum grip strength: by using hand dynamometer the patients will be seated on an armless chair with 90° flexion of hip and knee, their shoulders with 0° abduction and in the neutral position, their elbow at 90° flexion and their forearm in the neutral position, and their wrist in semi pronation with an upright thumb to provide a stronger grip. The protocol will consist of three maximal isometric contractions without pain for 5 s with a rest period of at least 60 s. The patients will perform three trials of grip strength using their involved and non-involved hands while maintaining 90° elbow flexion and neutral forearm position. The patients followed a verbal command of "slowly push, push, push, push, and relax" for each isometric contraction to ensure that the contractions lasted for approximately 5 s. The patients will be also asked to squeeze the dynamometer as hard as possible without the sensation of pain. The mean strength of three measurements will be recorded in kilograms
investigate the effect of magnesium sulfate on function ability in patients with lateral epicondylitis.
时间窗: 6 weeks
The elbow functionality will be determined using the Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) appendix II. The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The patients must rate their levels of pain and disability from 0 to 10. There are two subscales: the pain subscale (0 = no pain, 10 = worst pain imaginable) and the function subscale (0 = no difficulty, 10 = unable to do)
次要结局
- Elbow range of motion(6 weeks)
研究者
NOUR ALI ABO EL ELAA FRAGHLY
Lecturer assistant
Cairo University