Clinical Predictive Effects of Mulligan Treatment in Patients With Chronic Neck Pain: a Machine Learning Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
The aim of the study is the measurement and comparison of two manual therapy techniques, the Mulligan´s mobilization with movement technique, and de placebo technique, both applicated in patients with subacute neck pain.
详细描述
Study design:
A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial was conducted, where both the study subject and the researcher performing the measurements do not know which treatment group they belong to. Patients were randomly assigned using GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 2 study groups: experimental group and placebo group.
Participants:
The sample was composed of 42 sub-acute and inespecific neck pain patients residing in the Community of Madrid, all of whom were recruited personally for the study. Experimental group includes 21 subjects who received a manual theraphy technique named Mobilization with Movement (MWM) for a total of four sessions, distributed in two sessions per week. . Placebo group includes 21 subjects who received a placebo technique the same times.
Measurement instruments:
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
Neither the subjects assigned to the groups nor the researchers who measured the variables knew which group they belonged to.
Patients will be randomly assigned through GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 2 study groups
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
- •Ages between 18 and 60 years.
- •Neck pain with/without pain in upper limb/s.
- •Acceptance of the study and completion of the informed consent form.
排除标准
- •Presenting physician-diagnosed "red flag" of non-musculoskeletal origin.
- •Having had a Whiplash in the last 2 years.
- •Use of cervical collar in the last year.
- •Evidence of CNS involvement.
- •Vestibular Disorders
- •Inflammatory joint disease
- •Spinal cord pathology
- •Bone disease or marked osteoporosis
- •Intervertebral disc protrusion
- •Subjects who have received physiotherapeutic treatment of the cervical or thoracic region three months previously.
- •Fractures, sprain or dislocation of the neck, occurred in a period of less than two months.
- •Previous shoulder, upper limb and cervical spine surgery, which occurred in the twelve months prior to the investigation.
- •Pregnancy
- •Voluntary abandonment
结局指标
主要结局
Pressure Pain Threshold
时间窗: Change from base line and immediately after the intervention
The patient supine with algometer perpendicular to the exactly point for evaluation, and the pressure is increasing slowly and linearly. The intervention speed applied will be 1kg/cm2/second until the patient feels pain. Just in that moment, the researcher stops pressure. Hereby a target response is favored due to fact that patient has more reaction time when he starts to feel pain. In that moment, the researcher interrumps exercised pressure with the algometer. In every anatomical reference, three measures will be performed consecutively in intervals of 30 seconds for measurement to generate an average, neccesary for statical analysis. Pain pressure threshold measure is performed just before therapeutic intervention and 5 minutes later.
Visual Analog Scale (VAS)
时间窗: Change from base line and immediately after the intervention
To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.
Cervical Range of Movement (CROM)
时间窗: Change from base line and immediately after the intervention
Measurement of the range of movement by means of an inclinometer. To measure the range of movement the patient will be seated in a chair; feet supported on the floor, triple flexion of lower limbs of 90º (hip, knee and foot), back well supported and straight, head straight and look at the horizon. The inclinometer will be positioned to measure flexion, extension, right and left tilt and right and left rotation. The inclinometer for CROM (cervical range of motion) is approved and validated in different studies.
次要结局
- Beck II (Depression)(Change from base line and immediately after the intervention)
- STAI (State-Trait Anxiety)(Change from base line and immediately after the intervention)
- Neck Disability Index(Change from base line and immediately after the intervention)
研究者
Eleuterio Atanasio Sánchez Romero
Professor / Researcher
Universidad Europea de Madrid