Acute Effects of Therapeutic Ultrasound on Passive Cervical Muscle Stiffness and Pain in Adults With Neck Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in passive cervical muscle stiffness
研究概览
简要总结
This study will test whether one session of therapeutic ultrasound can immediately reduce muscle stiffness and pain in adults with neck pain. Participants aged 18-50 years who report neck pain of at least 3 out of 10 will be randomly assigned to one of two groups: (1) active ultrasound or (2) sham ultrasound. Both groups will receive the same 10-minute procedure with the probe moved slowly over the painful neck muscles; however, the sham device will not deliver ultrasound energy. Before and right after the session, we will measure passive muscle stiffness at standard points on the neck and shoulder muscles using a handheld device and will record pain intensity on a 0-10 scale. We will also record the Neck Disability Index on the same day. The main question is whether active ultrasound produces a larger immediate decrease in muscle stiffness than sham. We will also examine changes in pain and neck function. The session is performed by trained physiotherapists in a clinic setting. Potential risks are minimal (such as temporary warmth or mild skin redness). There is no cost to participate. Results may help guide safe, non-drug treatment options for neck pain.
详细描述
Background and Rationale. Therapeutic ultrasound is commonly used to manage musculoskeletal pain and stiffness, yet immediate, objective effects on cervical muscle stiffness are not well established. This trial evaluates whether a single session of continuous ultrasound produces a greater immediate reduction in passive cervical muscle stiffness and pain than a sham procedure.
Study Design. Single-session, parallel-group, randomized, sham-controlled clinical trial (1:1). Masking: participants and outcomes assessor (double-blind). Primary purpose: treatment. Setting: outpatient physiotherapy clinics at Erzurum (university/affiliated hospital).
Participants. Adults 18-50 years with neck pain and baseline pain ≥3/10 on a 0-10 scale. Key exclusions include neurological signs suggesting radiculopathy, pregnancy, pacemaker, open skin lesions/infection at the treatment area, and invasive neck treatment within the past 6 weeks.
Interventions.
Active ultrasound: Continuous therapeutic ultrasound applied to painful/stiff cervical musculature (e.g., upper trapezius and suboccipital/cervical extensors) for ~10 minutes. Frequency 1-3 MHz; intensity 1.0-1.5 W/cm² (adjusted to tolerance); slow, overlapping circular probe movement with standard coupling gel.
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 (Participant, Outcomes Assessor)
盲法说明
Sham ultrasound matches probe movement and duration; device shows normal indicators but delivers no acoustic output. Outcome measurements are performed by a blinded assessor.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •Neck pain with baseline intensity ≥ 3/10 on a 0-10 scale
- •Able to understand the study procedures and provide written informed consent
- •No invasive neck treatment within the past 6 weeks
排除标准
- •Neurological signs suggesting cervical radiculopathy or serious spinal pathology
- •Open wounds, infection, or severe skin disease at the treatment area
- •Pregnancy or implanted pacemaker
- •Acute cervical trauma or fracture history
- •Use of other neck-targeted physical therapies or analgesic procedures on the day of assessment
- •Any condition judged by the investigators to interfere with safe ultrasound application or outcome measurements
结局指标
主要结局
Change in passive cervical muscle stiffness
时间窗: Baseline (pre-treatment) to immediately after the single 20-minute session (same visit)
Dynamic stiffness (N/m) recorded with a handheld myotonometer at predefined points (sternocleidomastoid; upper/middle/lower trapezius; cervical extensors). Each site measured 3 taps and averaged; the limb-side with greater baseline pain is prioritized. Higher values indicate greater stiffness. Primary analysis compares between-group difference in change scores, adjusted for baseline.
次要结局
- Change in Neck Disability Index(Baseline to immediately after the session (same visit))
研究者
esedullah akaras
Assistant Professor & Principal Investigator; Department of Physiotherapy and Rehabilitation, Erzurum Technical University
Erzurum Technical University