Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain: Randomized Controlled Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- Effectiveness of osteopathic treatment
研究概览
简要总结
In Spain cervical pain affects practically 20% of the population annually, while globally it is estimated that between 22% and 77% of the population will suffer cervical pain at some point in their life. Prevalence increases with age, and is more common in women than in men (1.6: 1). Although the natural evolution of cervical pain tends to improve, the rates of recurrence and chronicity are high. And therefore it becomes an anatomical region of interest in relation to the assessment of the effectiveness and / or effectiveness of the osteopathic therapeutic approach. Different studies prove the efficacy of various manual therapy techniques applied on the cervical and / or upper dorsal region, suggesting significant positive changes in cervical pain and mobility levels in patients with nonspecific cervical pain. It is necessary to bear in mind that the reality of the osteopathic approach to the patient is not limited to the use of a single technique, but that the treatment is formed from a set of them. The ultimate goal is to restore mobility and functionality to a specific region, especially taking into account the concepts of individuality and holism.
A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.
详细描述
At the beginning of the 1st session, a battery of questions will be made as an anamnesis with the objective of evidencing possible risk factors at the therapeutic level. The presence of one or more risk factors will suppose the exclusion of the patient from the study.
Next, a brief osteopathic musculoskeletal evaluation will be made to the patient. This exploration will follow a standardized protocol for all patients in the experimental groups (1 and 2).
The tests to be carried out will be:
-
Observation (standing patient):
-
Assessment of the anterior projection of the head
-
Assessment of the variation in the physiological curves of the spine
-
Active test of the cervical spine with the patient in a sitting position.
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
A double masking is proposed. Three active interventions are compared. The patients will be blinded in relation to the study group they belong to, ensuring the masking of the participants.
The data that is intended to be obtained for its analysis are of a self-reported nature and will be collected and administered by an external investigator not linked to the interventions, ensuring the masking of the evaluator.
Due to the nature of the interventions, masking of therapists is not possible.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The sample will be formed by patients between the ages of 18 and 75 years, who present cervical pain of any intensity and duration, and with a minimum score of 10 points on the Neck Disability Index (NDI)14,15.
排除标准
- •Patients who present at the time of recruitment other pathologies or elements that may condition cervical pain, such as: acute shoulder tendinopathy, cervical radiculopathy, chronic diseases of general musculoskeletal involvement (Chronic Fatigue Syndrome and / or Fibromyalgia). Similarly, patients suffering from any type of vertiginous syndrome, who have suffered a whiplash in the last year or who are or have been under treatment for cervical pain in the last 3 months will also be excluded.
- •The taking of anti-inflammatories by the patient is not taken as a measure of exclusion. If the patient is under pharmacological treatment, it will be recorded and will be taken into account as a co-intervention. However, this treatment will not be modified under any circumstances nor will it be grounds for exclusion from the study.
结局指标
主要结局
Effectiveness of osteopathic treatment
时间窗: 12 weeks
The effectiveness of osteopathic treatment will be assessed using two health questionnaires ("SF-36" and "NDI") compared to an exercise plan in patients with nonspecific cervical pain.
次要结局
- Temporal Frequency(12 weeks)