Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The study is a single-center, double blinded, randomized controlled trial aimed to investigate the effects of focused extracorporeal shockwave therapy (fESWT) on Delayed Onset Muscle Soreness (DOMS) of the non-dominant biceps brachialis muscle in healthy voluntary adults.
详细描述
Forty-five participants agreed to participate and signed a written informed consent. After enrollment, muscle soreness was induced and participants were subsequently randomized to receive either (1) focused extracorporeal shockwave therapy (Verum), (2) sham shock wave (Sham) or (3) no treatment (Control). Thereafter, treatments were administered once, only. Measures were repeated after the treatment and at 24, 48 and 72 hours. Main outcome parameter was the pain intensity at rest and in movement as assessed by visual analogue scale (VAS) in the elbow region of the non-dominant arm. Secondary outcome included the pressure pain threshold (PPT) over the biceps muscle belly, the maximum isometric voluntary force (MIVF) of the elbow flexors and the assessing the impairment of activities of the daily living. Participants were followed-up 72 hours after the induction of Delayed Onset Muscle Soreness.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects
- •voluntariness
排除标准
- •pregnancy
- •musculoskeletal disease
- •systemic neurological disease
- •coagulation disorder
- •mental illness
- •drug addiction
- •allergy to the ultrasound gel
- •cardiac illness
- •vascular disease of the limbs or the central nervous system
- •regional scars
- •regional skin transplants or hypoesthesia
- •allergic or other forms of acute dermatitis
- •chronic intake of analgesic, neuroleptics, antidepressants, corticoids or alpha2-blockers
- •current state of delayed onset muscle soreness
- •extracorporeal shockwave therapy within last 2 weeks
研究组 & 干预措施
Verum focused extracorporeal shockwave therapy
Verum focused extracorporeal shockwave therapy is applied at 7 equidistant points, perpendicular to the belly of the biceps brachii muscle on a thought line between the radial tuberosity and the coracoid process (Dermagold120, Tissue Regeneration Technologies, Woodstock, Georgia, U.S.). Shock waves are generated by electrohydraulic mechanisms.
干预措施: Verum focused extracorporeal shockwave (Device)
Sham shock wave
Sham shock wave is performed using the same device as stated above, but using a special applicator that has been isolated with layers of metal and water by the manufacturer, extinguishing the transmitted energy. The study personal is blinded to the applicators. All handling, adjustments and noises are thus same in this group.
干预措施: Sham shock wave (Device)
Control
Control procedure stipulates participants to lay down on the same therapy table for 5 minutes receiving no intervention.
结局指标
主要结局
Pain intensity
时间窗: 72 hours
Pain intensity at the elbow region during active movement of the biceps muscle is assessed using a visual analogue scale (VAS) ranging from 0 to 10 cm (with 0 indicating no pain and 10 experiencing the worst imaginable pain).
次要结局
- Pressure pain threshold (PPT)(72 hours)
- Maximum isometric voluntary force MIVF(72 hours)
- Activities of daily living (ADL)(72 hours)
研究者
Dr. Johannes Fleckenstein
Senior Researcher
Goethe University