Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
研究概览
简要总结
Objectives: To evaluate the clinical efficacy of using a manual inhibition technique for the suboccipital muscles compared with the use of the so-called INYBI tool in individuals with chronic non-specific neck pain, and the compare the results of using both approaches on pain relief, cervical range of motion neck and vertical maximum mouth opening.
Design: Quantitative, experimental, longitudinal, prospective, and double blinded study.
Subjects: Patients between 18 and 40 years, with chronic non-specific neck pain of at least 3 months of evolution.
Methods: The experimental group will undergo a 5 minutes intervention for the suboccipital muscles using the INYBI tool. The control group will receive a 5 minutes of treatment involving the suboccipital muscles manual inhibition technique.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of non-specific mechanical neck pain.
- •Pain of more than 3 months of duration.
- •Pain between the occiput and the third dorsal vertebra.
- •Willingness to participate in the treatment and in the follow-up measurements
- •Neck pain reproduced by neck movements or palpation
排除标准
- •Cognitive impairment or inability to communicate.
- •Having received manual therapy in the last two months before recruitment.
- •Having received anti-inflammatory treatment, antidepressants or muscle relaxants in the last 72 hours.
- •Any contraindication to treatment or evaluation procedures.
- •Diagnosis of systemic diseases
- •Diagnosis of fibromyalgia
- •Pregnancy
- •Signs of spinal nerve root compression
- •Previous whiplash
- •Any diagnosed possible cause for their neck pain (infection, cancer, spinal stenosis)
研究组 & 干预措施
INIBY tool
Patients will undergo a single treatment session consisting of applying a suboccipital muscle inhibition technique using the so-called INYBI tool. The treatment session will last approximately 5 minutes
干预措施: INYBI tool (Device)
Manual suboccipital inhibition
Patients will receive a single treatment session consisting of the use of the manual suboccipital muscles inhibition technique.The treatment session will last approximately 5 minutes
干预措施: Manual suboccipital inhibition (Other)
结局指标
主要结局
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
时间窗: From baseline to immediately after treatment.
PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Active cervical range of movement (ROM). The range of movement will be assessed in degrees
时间窗: From baseline to immediately after treatment.
Flexion, extension, left and right side flexion, and left and right rotation will be assessed using a digital inclinometer.
Pain free vertical mouth opening. This outcome will be evaluated in centimeters.
时间窗: From baseline to immediately after treatment.
Maximum pain free vertical mouth opening will be assessed using a digital caliper that will place between the incisors 11, 21, 31 y 41.
Atlas rotation ROM, assessed in degrees
时间窗: From baseline to immediately after treatment.
The atlas bone left and right rotation ROM will be assessed using the flexion-rotation test. For this test, with the participant in supine position, the maximum mobility in head rotation while keeping maximum passive neck flexion will be assessed
Self-reported pain intensity
时间窗: From baseline to immediately after treatment.
Self-perceived pain intensity will be evaluated during all active cervical movements by a 0 to 10 Visual Analogue Scale (VAS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain
次要结局
未报告次要终点
研究者
Alberto Marcos Heredia-Rizo
Assistant Proffesor
University of Seville