Effectiveness of the Application of Radial Pressure Waves Together With a Manual Therapy Protocol and Therapeutic Exercise in the Treatment of Non-Specific Neck Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Muscle Elasticity
研究概览
简要总结
The present study aims to know the effectiveness of radial pressure wave therapy in the treatment of people with nonspecific neck pain. The study hypothesis is that including radial pressure wave therapy in a protocol based on manual therapy and therapeutic exercise is more effective than the protocol alone for the treatment of nonspecific neck pain.
Participants will be randomly assigned into 2 groups, one will be applied only the manual therapy and exercise protocol and the other the same protocol, plus shock wave therapy. Data related to the pathology will be collected and compared between the two groups to determine which treatment is more effective.
详细描述
Nonspecific neck pain is one of the main reasons for outpatient physiotherapy consultation and, due to its multifactorial origin, there are numerous approaches without a consensus on the effectiveness of the different treatments. The most recent systematic reviews show significant evidence about the efficacy of the combination of Manual Therapy (MT) and exercise on pain, muscle elasticity, posture, and functionality in patients suffering from neck pain.
During muscle evaluation, it is common to find painful pressure points that are not spontaneously. These asymptomatic areas, painful when pressed, appear as areas with loss of elasticity, when evaluated with quantitative elastography (shear wave), which influences their contractile capacity and their ability to develop strength, together with the inhibition caused by the pain. The accumulation of cytotoxic and nociceptive substances, derived from the excess activity, could be the cause of the shortening of muscle fibers, so an increase in vascularity could help improve their drainage and normalize their elasticity and functionality.
Radial shock waves have been shown to be effective in angiogenesis, increasing vascularity and oxygen saturation of treated areas, so it could be a useful tool to help solve this problem.
This study aims to determine the effectiveness of radial shock waves to locate and treat the areas of loss of elasticity, found during muscle evaluation, combined with a MT and exercise protocol, compared to the manual therapy and exercise protocol itself. To do this, participants will be randomly assigned into 2 groups, one will be applied only the manual therapy and exercise protocol and the other the same protocol, plus shock wave therapy. The data collected will be compared between the two groups. An intention-to-treat statistical analysis will be performed.
Objective:
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
- None
盲法说明
Blinding of investigators at study inclusion to randomization sequence, using sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Specific Neck Pain (NSNP)
- •Age between 18 and 59 years,
排除标准
- •Previous spine surgery.
- •Neurological pathology.
- •Rheumatoid arthritis.
- •Fibromyalgia.
- •Vertebral fractures or fissures.
- •Radiculopathies.
- •Neurogenic pain.
- •History of cervical trauma.
- •Congenital spinal anomalies.
- •Wear a cardiac pacemaker.
- •Currently receiving physiotherapy treatment in the same body area where the study is carried out.
- •Currently being treated with anticoagulants or antiaggregants.
- •Have an infectious or neoplastic nucleus close to the body area under study.
结局指标
主要结局
Change in Muscle Elasticity
时间窗: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Using Shear Wave Elastography
次要结局
- Change in Active Range of Motion(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Change in Jerk of cervical movements(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Change in Shoulder lift strength(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Change in Pain Pressure Threshold(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Change in Cervical Pain assessed by Visual Analog Scale for acute pain (Spanish version)(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Weight in kilograms(Baseline)
- Change in the Quality of life assessed by the SF-12 questionnaire (Spanish version)(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Change in Disability assessed by the Neck disability index (NDI) questionnaire (Spanish version)(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Change in Kinesiophobia assessed by the Tampa Scale for Kinesiophobia-11 (TSK-11) questionnaire (Spanish version)(Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement)
- Number of sore spots(Baseline)
- Age in years(Baseline)
- Gender(Baseline)
- Height in centimeters(Baseline)
- Educational level(Baseline)
- Dominance(Baseline)
- Work Activity(Baseline)
- Body Mass Index (BMI)(Baseline)
- Sports Activity, assessed by Rapid Assessment of Physical Activity-1 (RAPA-1) test(Baseline)
研究者
Carlos López Moreno
Principal investigator
Universidad Pontificia Comillas