Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- salivary cortisol
研究概览
简要总结
Currently, there are many studies about the effects of manual therapy on pain, but there are not enough studies to know what are the mechanisms that cause these effects.
Although there is a research measuring neuromodulators substances after a cervical and dorsal manipulation, it has been done in healthy subjects and there is no information about mobilization. This work aims to select a sample with chronic neck pain, incorporating the cervical mobilization as a therapeutic approach to compare the effects of both techniques because not all patients accept the manipulation as a treatment technique (mobilization is much better tolerated) and to verify that the liberation of cortisol is not just caused by the stress on the joint manipulation and the psychological stress and expectation may be important.
The hypothesis of this paper is that cervical manipulation and mobilization in subjects with chronic neck pain there will increase salivary cortisol levels.
It is also expected a little increase in the expectation of being manipulated group because of the psychological stress.
It is expected an improvement in the neck disability, pain and range of motion in the intervention groups immediately after and in the three groups the following week after the exercise.
The main objective of the study is to measure and analyze changes in salivary cortisol concentrations after the intervention in the three groups. Secondary objectives is to analyze the changes in range of motion and disability caused by neck pain neck pain level
详细描述
STUDY DESIGN:
Experimental study using a randomized controlled trial with blinded evaluator with three parallel groups, two experimental and one placebo.
INTERVENTION
- Experimental group cervical manipulation:
The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust. If the segment to manipulate is the upper cervical spine, the radial aspect of the distal phalanx of the index finger of the pulse is placed on the posterolateral aspect of the transverse process of the atlas (In medium or low segments of cervical spine on the vertebra on which we want to make the thrust). The thumb rests on the zygomatic arch and the other fingers rest on the back of the skull, leaving the forearm perpendicular to the neck. In middle or lower cervical spine, the thumb rests on the angle of the jaw and the other fingers on the back of the neck.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Manifest mechanical pain in the neck to the T1 vertebra as lower limit
- •Present the medical diagnosis of mechanical neck pain
- •Do not be getting any kind of hormonal therapy (including oral contraceptives)
- •Be over 18 years old
排除标准
- •Subjects that are associated with the adrenal gland pathology
- •Pathologies excess or defect of cortisol
- •Pathology severe psychological disorders related to anxiety, mood or stress
- •Participants pregnant due to changes in hormonal determinations
- •Contraindication to manipulation or mobilization
结局指标
主要结局
salivary cortisol
时间窗: Change from baseline cortisol concentration at after the intervention(immediately after)
For measuring salivary cortisol a Cortisol kit RE52611 ELISA® will be provided by the IBL laboratory. The saliva samples will be stored at -20 ° C until analysis, being coded by the researcher and measured by a blinded assessor. For this, it will be added 50 uL sample of saliva in the tubes of the kit with a pipette. Subsequently 100 uL of enzyme conjugate will be added to each tube, covering the plate with adhesive and shaking carefully. It will be incubated 2 hours at room temperature (18-25 ° C) in a centrifuge at 400-600 rpm. After removing the adhesive and remove excess of solution wil be added 100 uL of TMB solution. It wil be centrifuged for 30 min under the same conditions. At the end, they wil be added 100 uL of TMB solution inhibitory. The results wil be measured with a photometer at 450 nm within 15 minutes of adding the last reagent.
次要结局
- Neck Disability(Change from baseline disability at one week after intervention)
- Neck pain(Change from baseline neck pain at one week after intervention)
- Tenderness(Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after)
- Cervical joint Range(Change from baseline mobility at immediately after at one week after intervention)
研究者
Prof. Dr. Daniel Pecos Martín
Dr. Pecos-Martin, D
University of Alcala