Comparison Between High-Intensity Laser Therapy and Extracorporeal Shockwave Therapy in the Treatment of Myofascial Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale for Pain Intensity
研究概览
简要总结
This randomized single-blind controlled trial compares the effectiveness of High-Intensity Laser Therapy (HILT) versus Extracorporeal Shockwave Therapy (ESWT), both combined with standardized traditional physiotherapy, in patients with upper trapezius myofascial pain syndrome. Forty participants will be randomly assigned to receive either HILT (12 sessions over 4 weeks) or ESWT (4 sessions over 4 weeks). Primary outcome is pain intensity (NPRS); secondary outcomes include pressure pain threshold, neck disability index, and cervical range of motion.
详细描述
This randomized single-blind controlled trial aims to compare the efficacy of High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT) in managing patients with myofascial pain syndrome (MPS) of the upper trapezius/cervical region. Forty adults (20-45 years) diagnosed with MPS according to Travell and Simons' criteria will be randomly allocated (1:1) to either:
- HILT Group: Class IV pulsed Nd:YAG laser (1064 nm), peak power 3000 W, average power 10 W, frequency 1000 Hz, energy density 12-15 J/cm² per trigger point, 3 sessions/week × 4 weeks (12 total sessions).
- ESWT Group: Radial extracorporeal shockwave therapy, energy flux density 0.08-0.12 mJ/mm², frequency 8-10 Hz, ~1500 pulses/session, 1 session/week × 4 weeks (4 total sessions).
Both groups receive an identical standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization). Primary outcome: pain intensity (Numeric Pain Rating Scale). Secondary outcomes: pressure pain threshold (digital algometer), Neck Disability Index, and active cervical range of motion (CROM device). Assessments at baseline and week 4. The study is conducted at Faculty of Physical Therapy, Benha University, Egypt.
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)
盲法说明
Single-blind (Outcome Assessor)
Masking Description:
Due to the physical nature of the interventions, blinding of treating therapists and participants was not feasible. However, outcome assessors and data analysts remained blinded to group allocation throughout the study. Participants were instructed not to disclose their treatment type during outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 18-60 years. Diagnosis of Myofascial Pain Syndrome (MPS) in the neck/shoulder region. Presence of active myofascial trigger points in the upper trapezius. Willingness to provide informed consent.
排除标准
- •History of cervical spine surgery, trauma, or radiculopathy. Contraindications to laser or shockwave therapy. Presence of systemic diseases (e.g., rheumatoid arthritis, malignancy). Receiving other physical therapy interventions during the study period
研究组 & 干预措施
High-Intensity Laser Therapy (HILT)
Participants will receive high-intensity laser therapy (HILT) using a Class IV pulsed Nd:YAG laser system (wavelength 1064 nm). Treatment parameters: peak power 3000 W, average power 10 W, frequency 1000 Hz (pulsed mode), energy density 12-15 J/cm² per trigger point, 4-6 active myofascial trigger points treated per session, total treatment duration 8-10 minutes per session. Treatment will be administered three times weekly for four weeks (total 12 sessions), combined with a standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization exercises).
干预措施: High-Intensity Laser Therapy (HILT) (Radiation)
Extracorporeal Shockwave Therapy (ESWT)
Participants will receive radial extracorporeal shockwave therapy (ESWT) using a pneumatic device (Gymna-Uniphy NV, Bilzen, Belgium). Treatment parameters: energy flux density 0.08-0.12 mJ/mm² (corresponding to device pressure setting 2.0-2.5 bar), frequency 8-10 Hz, approximately 1500 pulses per session delivered to active myofascial trigger points (500 pulses per trigger point). Treatment will be administered once weekly for four weeks (total 4 sessions), combined with a standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization exercises).).
干预措施: Extracorporeal Shockwave Therapy (ESWT) (Other)
结局指标
主要结局
Numeric Pain Rating Scale for Pain Intensity
时间窗: Baseline and 4 weeks after intervention (post-treatment)
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 = "no pain" and 10 = "worst imaginable pain". Assessments will be conducted at rest and during active cervical movement. The primary metric is the mean change in NPRS score from baseline to post-treatment (week 4). Lower scores indicate improvement. \[Time Frame: Baseline and 4 weeks post-intervention\]
次要结局
- Pressure Pain Threshold (PPT) as measured by pressure algometer(Baseline and 4 weeks post-treatment)
- Neck Disability Index (NDI)(Baseline and 4 weeks post-treatment)
- Cervical Range of Motion (ROM)(Baseline, 4 weeks)
研究者
reda abd elrazik
Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University
Benha University