Comparison of Extracorporeal Shock Wave Therapy, Ultrasound and Dexamethasone Iontophoresis in Patients With Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of disability
研究概览
简要总结
Lateral epicondylitis (LE) is one of the most common causes of non-traumatic elbow pain, which develops as a result of repetitive stresses due to overuse of the forearm muscles, and is also called tennis elbow.Conservative treatment options include electrotherapy, exercises, extracorporeal shock wave therapy (ESWT), steroid injections, platelet rich plasma, hyaluronic acid injections. As our knowledge this is the first study comparing the three different treatment modalities ESWT, Us and Iontophoresis on lateral epicondylitis The aim of our study; to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments against each other.
详细描述
This is a prospective randomized single blind clinical study. A total of 78 patients age between 18-65 who were diagnosed with lateral epicondylitis between June 2023 and December 2023 were included in our study. The study was approved by the University Ethics Committee (2023-77) and written informed consent was obtained from all the patients. The study was carried out in accordance with the principles of the Declaration of Helsinki.
Patients who had pain at the lateral epicondyle at least for four weeks, detection of sensitivity by palpation on the lateral epicondyle and having positivity in at least two of the special tests (Cozen test, Maudsley test and Mills test) were included in the study. Physical therapy, ESWT or local injections for lateral epicondylitis within the last 3 months, the presence of cervical radiculopathy, carpal tunnel syndrome, other neuropathic diseases, neurologic diseases, medial epicondylitis, systemic inflammatory diseases, tenderness or swelling at the ipsilateral extremity and fibromyalgia have been excluded.
Patients were randomized into three groups by a physiotherapist with sealed envelopes. The researchers were blinded to the patient's groups. The same physiotherapy program was applied to all groups. The physiotherapy program consisted of hot packs and transcutaneus electrical nerve stimulation (TENS) for 10 minutes and stretching and eccentric strengthening exercises were given to all groups. All exercises were done under the supervision of the same physiotherapist.
In addition to the ten-day of physiotherapy program, in the first group one day for a week a total of 3 sessions of ESWT was applied at 1.8 bar, 10.0 Hz, 2000 beats (Elmed Vibrolith Ortho).
In the second group, ten days of ultrasound applied at 1.5 watt/cm2, continuous mode to the painful area for 5 minutes, 5 days a week for two weeks (Chattanooga Intelect Advanced).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
- Participant : patients with lateral epicondylitis
- Care provider: physiotherapist who applied the treatment (ESWT,US,iontophoresis)
- Investigator: examine the patients and evaluates the results of the study
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 who had pain at the lateral epicondyle at least for four weeks,
- •detection of sensitivity by palpation on the lateral epicondyle and
- •having positivity in at least two of the special tests (Cozen test, Maudsley test and Mills test) were included in the study
排除标准
- •Physical therapy, ESWT or local injections for lateral epicondylitis within the last 3 months,
- •the presence of cervical radiculopathy, carpal tunnel syndrome, other neuropathic diseases, neurologic diseases, medial epicondylitis, systemic inflammatory diseases, --
- •tenderness or swelling at the ipsilateral extremity and
- •patients with fibromyalgia have been excluded.
结局指标
主要结局
Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of disability
时间窗: 6 months from June 2023 to December 2023
Upper extremity disability levels were assessed with Quick Disabilities of the Arm, Shoulder and Hand questionnaire The Quick-DASH is an 11-item that measures upper extremity activity limitation and symptoms . Items were scored from 1: indicating no functional limitation and no symptoms, to 5: indicating functional inability and extreme symptoms. The tota lscore was computed by transforming the mean items score to a scale from 0 to 100, where 0 indicates the best upper extremity function and no symptoms. Turkish version of the test was evaluated. Quality of life was measured by notthingham health profile (NHP) questionaireQuality of life was measured by notthingham health profile (NHP). Scale, 6 dimensions, total It consists of 38 items. Sub-dimensions: Energy (3 items), pain (8 items), emotional status (9 items), sleep (5 items),social isolation (5 items) and physical activity (8 items). Its range is 0-100is scored. As the score increases health status gets worse.
Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in term of pain
时间窗: 6 months from June 2023 to December 2023
Investigators aimed to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of pain, grip strength, functionality and quality of life in patients with lateral epicondylitis. Numerical Rating Scale (NRS) was used for the pain assessment The NRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
- Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of strength(6 months from June 2023 to December 2023)
研究者
Pınar Özge Başaran
Principal Investigator
Hitit University