Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The goal of this clinical trial is to investigate the efficacy of mesotherapy in patients with lateral epicondylitis and to determine whether it is as effective as extracorporeal shock wave therapy (ESWT).
Is mesotherapy an effective method in patients with lateral epicondylitis?
Researchers will compare Mesotherapy to extracorporeal shock wave therapy (ESWT) in patient with Lateral epicondylitis.
Patients will be randomly assigned to either the Mesotherapy group or the ESWT group using a closed envelope method.
- Group 1 (Mesotherapy group): Patients will receive a total of 5 sessions of mesotherapy, with one session every 7 days.
- Group 2 (ESWT group): Patients will receive a total of 5 sessions of Extracorporeal Shock Wave Therapy (ESWT), with one session every 7 days.
Patients will be assessed at three time points: before treatment, 30 minutes after the completion of the treatment, and 12 weeks after the completion of the treatment
详细描述
This randomised-controlled single-blind prospective study was carried out at a Physical Medicine and Rehabilitation out-patient clinic. After approval by the Ethics Committee, all participants signed a written informed consent form. The research was conducted in accordance with the Helsinki Declaration.
Participants
The study will include individuals with lateral epicondylitis who are between the ages of 18 and 65 and have had elbow pain for at six weeks. Pain around the lateral epicondyle during resisted extension of wrist and fingers and tenderness over the lateral epicondyle were required for the diagnosis of lateral epicondylitis. Patients with the following exclusion criteria were not accepted into the study:
- Receiving an interventional injection in the elbow region within the last 3 months
- Receiving physical therapy in the last 3 months
- Receiving regular nonsteroidal anti-inflammatory drug (NSAID) treatment in the last 2 weeks
- History of fracture or surgery in the affected elbow region
- Chronic inflammatory diseases
- Acute infection
- History of malignancy
- Coagulation disorders
- Pregnancy
- Presence of a pacemaker or electronic implants
- Cervical radiculopathy and entrapment neuropathy
- Drug allergies
- BMI > 35
Demographic informations were recorded. Severity of elbow pain in activity were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with The Patient-Rated Tennis Elbow Evaluation , Short-Form-Health-Survey-12 (SF-12 )
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
- Single (Outcomes Assessor)
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
- •Aged between 18 and 65 years
- •Pain and tenderness in the unilateral lateral epicondyle for ≥6 weeks
- •Clinically diagnosed with Lateral Epicondylitis
- •Patients without cognitive deficits who can follow verbal instructions
排除标准
- •Receiving an interventional injection in the elbow region within the last 3 months
- •Receiving physical therapy in the last 3 months
- •Receiving regular nonsteroidal anti-inflammatory drug (NSAID) treatment in the last 2 weeks
- •History of fracture or surgery in the affected elbow region
- •Chronic inflammatory diseases
- •Acute infection
- •History of malignancy
- •Coagulation disorders
- •Pregnancy
- •Presence of a pacemaker or electronic implants
- •Cervical radiculopathy and entrapment neuropathy
- •Drug allergies
- •BMI > 35
研究组 & 干预措施
Group 1 (Mesotherapy group)
The intradermal mesotherapy will be applied to the painful points in the elbow using a 4 mm long, 30G needle with a point-by-point technique at a 90-degree angle. The injection volume per point will be 0.1 cc. Following this, a "nappage" technique with a 45-degree angle will be applied around the common extensor tendon.Mesotherapy solution will contain 1 cc 0.1% lidocaine, 1 cc pentoxifylline, 1 cc thiocolchicoside, 1 cc meloxicam 1⁄4 diluted with 0.9% physiological isotonic saline. Patients will receive a total of 5 sessions of mesotherapy, with one session every 7 days.
干预措施: Mesotherapy (Procedure)
Group 2 (ESWT group)
For patients in Group 2, Extracorporeal Shock Wave Therapy will be applied to the lateral epicondyle area at 10-15 Hz frequency, 1.5-2.5 bar energy density, and 2000 pulses. Patients will receive a total of 5 sessions of Extracorporeal Shock Wave Therapy (ESWT), with one session every 7 days.
干预措施: Extracorporeal Shock Wave Therapy (Device)
结局指标
主要结局
VAS
时间窗: All measures were conducted at baseline, at the end of treatment (Week 5), at 12th weeks follow-up
Measurement of pain intensity using the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line with endpoints representing 0 ("no pain") and 10 ("pain as bad as it could possibly be"). Minimum score: 0 Maximum score: 10 Higher scores indicate worse pain.
Patient-Rated Tennis Elbow Evaluation
时间窗: All measures were conducted at baseline, At the end of treatment (Week 5), at 12th weeks follow-ups
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (tennis elbow). Scores range from 0 to 100, with higher scores indicating greater pain and disability.
SF-12 Health Survey
时间窗: All measures were conducted at baseline,At the end of treatment (Week 5) , 12th weeks follow-ups
A self-reported measure assessing health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health status.
次要结局
- Algometer Measurement of Pressure-Pain Threshold(All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.)
- Hand Dynamometer for Grip Strength(All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.)
研究者
Berna Gunay, MD
Specialist Physician
Haydarpasa Numune Training and Research Hospital