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临床试验/NCT07660523
NCT07660523招募中不适用

Effectiveness of Second-Generation Focused Extracorporeal Shockwave Therapy Combined With Ultrasonographic Assessment in Myofascial Pain Syndrome of the Neck and Shoulder: A Pilot Randomized Controlled Trial

Cishan Hospital, Ministry of Health and Welfare1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1

研究概览

简要总结

Myofascial pain syndrome of the neck and shoulder is a common condition characterized by persistent muscle pain, tenderness, stiffness, and limitations in daily activities. Focused extracorporeal shockwave therapy is a noninvasive treatment that may reduce pain and improve muscle function. However, additional clinical evidence is needed regarding the effectiveness of second-generation focused shockwave therapy and whether ultrasound imaging can objectively detect changes in muscle function after treatment.

This pilot randomized controlled trial will enroll 60 adults with chronic neck and shoulder myofascial pain syndrome. Participants will be randomly assigned to either a focused shockwave therapy group or a home-based neck exercise group.

Participants in the focused shockwave therapy group will receive one treatment session per week for three consecutive weeks. Participants in the control group will perform a standardized home exercise program designed to improve neck mobility and reduce muscle tightness.

Assessments will be performed before the intervention, after the intervention, and at follow-up. Study outcomes will include pain intensity measured using the Visual Analogue Scale, neck-related disability measured using the Neck Disability Index, pressure pain threshold measured using an algometer, and upper trapezius muscle thickness and contraction-related changes measured using ultrasound imaging.

The primary objective is to determine whether focused shockwave therapy is more effective than a home-based neck exercise program in reducing pain and improving neck function. The study will also evaluate whether ultrasound-derived muscle measurements are associated with changes in pain, pressure sensitivity, and functional disability.

详细描述

Myofascial pain syndrome of the neck and shoulder is a common musculoskeletal pain condition characterized by painful and sensitive areas within tight bands of muscle, commonly referred to as myofascial trigger points. These trigger points frequently occur in the upper trapezius and levator scapulae muscles and may cause localized pain, referred pain, muscle stiffness, reduced neck movement, sleep disturbance, and limitations in work and daily activities. Persistent symptoms may also contribute to altered posture, reduced muscle performance, and decreased quality of life.

Focused extracorporeal shockwave therapy is a noninvasive treatment that delivers acoustic energy to painful soft tissues. Proposed effects include improved local circulation, modulation of pain-related nerve signaling, reduction of abnormal muscle tension, and stimulation of tissue repair. Second-generation focused shockwave systems use piezoelectric technology to provide a stable and precisely focused energy field. This technology may be particularly suitable for treating relatively superficial muscles, such as the upper trapezius.

Ultrasound imaging provides a noninvasive method for evaluating muscle structure and function. In addition to measuring resting muscle thickness, ultrasound can be used to assess changes in muscle thickness during different levels of contraction. These measurements may provide objective information regarding muscle function that cannot be obtained from pain questionnaires alone. In this study, ultrasound imaging will be used only as an outcome assessment tool and will not be used to guide the location of shockwave treatment.

This study is a pilot randomized controlled trial designed to evaluate the effectiveness of second-generation focused extracorporeal shockwave therapy in adults with chronic neck and shoulder myofascial pain syndrome. Approximately 60 participants will be enrolled and randomly assigned in a 1:1 ratio to either a focused shockwave therapy group or a home-based neck exercise group.

Eligible participants will be adults older than 20 years who have had nonspecific neck and shoulder pain for at least 3 months. The pain must primarily arise from muscles and soft tissues in the upper trapezius or levator scapulae region, as determined by a physical medicine and rehabilitation physician. Participants must also have a Neck Disability Index score greater than 5 and must not have recently received pain medication, muscle relaxants, injections, physical therapy, or other related treatment.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults older than 20 years.
  • Clinical diagnosis of nonspecific neck and shoulder pain primarily arising from muscles and soft tissues in the upper trapezius or levator scapulae region, as determined by a physical medicine and rehabilitation physician.
  • Neck and shoulder pain lasting for at least 3 months.
  • Neck Disability Index score greater than
  • No use of analgesic medication or muscle relaxants within the previous month.
  • No injection therapy, physical therapy, or other treatment for neck and shoulder pain within the previous month.
  • Ability to understand the study procedures and provide written informed consent.

排除标准

  • Neck or shoulder pain caused by a neurologic disorder, including cervical radiculopathy.
  • Clinical or imaging diagnosis of cervical degenerative joint disease.
  • History of a rheumatic disease, including rheumatoid arthritis or systemic lupus erythematosus.
  • History of head or neck trauma.
  • History of cervical spine surgery.
  • History of whiplash injury.
  • Pregnancy.
  • Current or previous malignancy considered clinically relevant to shockwave therapy.
  • Bleeding disorder.
  • Current use of anticoagulant medication, including warfarin.
  • Acute inflammation or infection at the treatment site.
  • Implanted cardiac pacemaker or implantable cardioverter-defibrillator.
  • Any other condition judged by the study physician to make participation or focused shockwave therapy inappropriate or unsafe.

研究组 & 干预措施

Focused Extracorporeal Shockwave Therapy

Experimental

Participants assigned to this arm will receive second-generation focused extracorporeal shockwave therapy applied to clinically identified tight and painful regions of the upper trapezius and levator scapulae muscles. Treatment will be administered once weekly for 3 consecutive weeks using the Richard Wolf PiezoWave system. Each treatment session will include approximately 3,000 shockwave pulses at a treatment depth of 20 to 25 mm and a frequency of 2 to 4 Hz. The energy level will begin at level 4 and may be gradually increased to a maximum of level 15 according to the participant's clinical response and tolerance.

干预措施: Second-Generation Focused Extracorporeal Shockwave Therapy (Device)

Home-Based Neck Exercise Program

Active Comparator

Participants assigned to this arm will receive instruction in a standardized home-based neck exercise program for 3 weeks. The program includes cervical flexion, extension, right and left rotation, right and left lateral flexion, and right and left upper cervical rotation performed with the neck in a flexed position. Participants will receive initial instruction and movement correction from a qualified physical therapist, together with written educational materials. Adherence and exercise-related difficulties will be monitored during the study.

干预措施: Home-Based Neck Exercise Program (Behavioral)

研究者

发起方
Cishan Hospital, Ministry of Health and Welfare
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Hui Tuan

Attending Physician and Principal Investigator

Cishan Hospital, Ministry of Health and Welfare

研究点 (1)

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