Mmediate and Short-Term Effects of Dry Needling, Percutaneous Neuromodulation, and Percutaneous Electrolysis on Muscle Tone and Pain: A Two-Phase Randomized Experimental Study in Healthy Subjects and Patients With Chronic Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Brief Summary:
This project consists of two sequential experimental phases designed to analyze the immediate and 24-hour effects of three invasive physiotherapy techniques -dry needling (DN), percutaneous neuromodulation (PENS), and percutaneous electrolysis (EPE)- on muscle tone and pain perception.
In the first phase, the study will be conducted on healthy volunteers to assess the physiological responses and safety profile of the interventions under controlled conditions. Each participant will receive one of the three randomly assigned interventions (DN, PENS, or EPE), applied to the upper trapezius muscle. Pain perception (Visual Analog Scale, VAS) and muscle mechanical properties (tone, stiffness, and elasticity) will be measured before and after the intervention, and after 24 hours, using the MyotonPRO device.
In the second phase, the same protocol and parameters will be applied to patients with chronic neck pain, in order to compare the magnitude and persistence of the effects between healthy subjects and symptomatic individuals.
This study aims to improve understanding of the short-term physiological mechanisms of invasive physiotherapy techniques and their relative effectiveness in managing chronic neck pain. The findings will contribute to the development of more precise and evidence-based treatment protocols for musculoskeletal pain.
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 (Participant)
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
- •Phase 1 - healthy subjects
- •Age between 18 and 65 years.
- •Healthy individuals without any current musculoskeletal or neurological pathology.
- •Presence of a palpable myofascial trigger point in the upper trapezius muscle.
- •No neck or shoulder pain requiring medical treatment in the past three months.
- •Willingness to refrain from other physiotherapy or manual therapy interventions during the study period.
- •Ability to understand and provide written informed consent
- •Phase 2 - Patients with Chronic Neck Pain
- •Age between 18 and 65 years.
- •Diagnosis of chronic mechanical or tension-type neck pain lasting for at least 3 months.
- •Presence of at least one active myofascial trigger point in the upper trapezius muscle.
- •Pain intensity between 3 and 7 on a 10-cm Visual Analog Scale (VAS) at baseline.
- •No previous invasive physiotherapy treatments (dry needling, electrolysis, or neuromodulation) within the last 4 weeks.
- •Ability and willingness to attend all study sessions and follow-up assessments.
- •Signed informed consent before participation.
排除标准
- •History of cervical or shoulder surgery.
- •Neurological, systemic, or rheumatologic disorders affecting the cervical or upper limb region.
- •Anticoagulant therapy or known bleeding disorders.
- •Pregnancy or suspected pregnancy.
- •Skin infection, wound, or dermatological condition at or near the intervention site.
- •Use of analgesic, anti-inflammatory, or muscle relaxant medications within 48 hours prior to the intervention.
- •Prior invasive physiotherapy (dry needling, PENS, or EPE) in the target area during the past month.
- •Contraindications to electrical stimulation (for PENS or EPE groups), such as implanted pacemaker or metal implants near the treatment area.
- •Fear of needles (trypanophobia) or intolerance to invasive procedures.
- •Participation in another clinical trial within the past 3 months.
- •Refusal or inability to provide informed consent
研究组 & 干预措施
Dry needling
干预措施: Dry needling (Procedure)
Percutaneous electrical nerve stimulation
干预措施: Percutaneous nerve stimulation (Procedure)
Percutaneous electrolysis
干预措施: Percutaneous electrolysis (Procedure)
结局指标
主要结局
Pain intensity
时间窗: Baseline (pre-intervention), immediately post-intervention, and 24 hours post-intervention.
Pain perception will be measured using a 10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Participants will mark their perceived pain intensity at rest. The scale is a reliable and validated tool for assessing subjective pain in musculoskeletal disorders.
次要结局
- Muscle tone(Baseline and immediately post-intervention, and 24 hours post-intervention)
- Muslce stiffness(Baseline, immediately post intervention and 24 hours post-intervention)
- Muscle elasticity(Baseline, immedialely post intervention and 24 hours post intervention)
研究者
Carlos Romero Morales
Physiotherapist
Universidad Europea de Madrid