Comparative Study of the Effects of Intratissue Percutaneous Electrolysis vs. Dry Needling in the Treatment of Myofascial Pain Syndrome in Subjects With Non-specific Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes in Pain intensity, before, during and after the intervention
研究概览
简要总结
This is a parallel-group randomised clinical trial:
Primary purpose: To analyse the clinical changes produced by two different physiotherapy treatments (Intratissue Percutaneous Electrolysis and Dry Needling) for myofascial trigger points in the infraspinatus muscle in subjects with non-specific shoulder pain.
Hypothesis: A physiotherapy treatment including Intratissue Percutaneous Electrolysis therapy present greater benefits in terms of pain reduction and increased mobility and functionality rather than Dry Needling treatment in subjects with non-specific shoulder pain.
The intervention consisted of 3 treatment sessions, different according to the group, once a week. Seven evaluation points were performed, two pre-intervention evaluations one week apart and after the second one the first treatment session was performed. The third and fourth assessments were prior to the second and third treatment sessions, one week apart. The fifth, sixth and seventh assessments were conducted one week, one month and two months after the last treatment session in each group.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female patients suffering from shoulder pain during at least three months before intervention protocol starts.
- •Patients with free passive range of movement and at least 15 degrees active external rotation in the affected shoulder.
- •Patients willing to participate in the study and return for all scheduled follow-up visits.
- •Patient is capable of giving, and has given, written informed consent.
排除标准
- •Patients with a previous medical diagnosis (tendon rupture, bursitis, etc.) or a traumatic history that justifies shoulder pain.
- •Patients with unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias.
- •Patients allergic to metal or those who have needle phobia.
- •Patient that has participated in any other shoulder pain treatment research study within 30 days prior.
- •Patients that had prior shoulder surgery.
- •Patients that are currently being treated with a narcotic or NSAIDs and/or has used analgesics or NSAIDs within the 72 hours prior.
- •Patients that has a known bleeding disorder or that are currently being treated with anticoagulant therapy.
- •Pregnant women.
结局指标
主要结局
Changes in Pain intensity, before, during and after the intervention
时间窗: 4 months (7 points)
Numerical pain rating scale (score 0-10 points)
次要结局
- Changes in Shoulder flexion range of motion, before, during and after the intervention(4 months (7 points))
- Changes in Pressure pain threshold at proximal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention(4 months (7 points))
- Changes in Pressure pain threshold at distal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention(4 months (7 points))
- Changes in Strength in shoulder external rotation before, during and after the intervention(4 months (7 points))
- Changes in Hand grip strength, before, during and after the intervention(4 months (7 points))
- Changes in Shoulder external rotation range of motion, before, during and after the intervention(4 months (7 points))
- Changes in Disability and functionality of the upper limb, before, during and after the intervention(4 months (7 points))
研究者
Roberto Méndez Sánchez
Professor, PhD
University of Salamanca