Effectiveness of Cervical Osteopathic Manipulation Techniques of High Velocity and Low Amplitude in Patients With Whiplash- Associated Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Neck specific disability
研究概览
简要总结
To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program.
详细描述
A prospective, single-blind, parallel group, randomized, will be carried out in the physiotherapy service of the Clinic Hospital of Terrassa with the participation of the rehabilitation, radiology, traumatology and surgery services.
Patients will be recruited from emergency services of the Clinic Hospital of Terrassa and randomly divided into two groups MAN-Group and RHB-Group, using the random number generator of a statistical program (SPSS), to receive 3 and 20 treatment sessions, respectively.
The treatment protocol was carried out during four weeks, and both interventions occurred over the same time period. In both treatment groups, patients started sessions during the first two week after the traffic car collision.
MAN-Group were treated with cervical spine manipulation with SAT, after specialized physical therapists assessed there was no risk of vertebro-basilar injuries following the International Framework. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).
The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks. The exercises were performed five times (30 seconds interval each time) 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 (Investigator, Outcomes Assessor)
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
- •Patients between 18-60 years of age Who went to the emergency service after suffering a traffic car collision being the driver of the car.
- •With acute WL grade II WAD diagnosis, made by physicians from the traumatology service (with neck pain by whiplash trauma with objective findings but no radiculopathy).
- •Referred to the hospital rehabilitation service
排除标准
- •Any other symptomatology different to neck pain and other coexisting medical conditions which could severely restrict participation in the study.
研究组 & 干预措施
Experimental: MAN Group
MAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).
干预措施: RHB Group (Procedure)
MAN Group
MAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).
干预措施: RHB Group (Procedure)
结局指标
主要结局
Neck specific disability
时间窗: At baseline and at week 2, 4 and follow-up.
Neck-specific disability was measured with Neck Disability Index (NDI). The NDI is a valid measurement of disability in neck pain disorders. It is widely used and it has shown good reliability and validity in WAD studies. NDI scores can range from 0% (no limitation on activity) to 100% (worst possible disability).
Subjective pain intensity
时间窗: At baseline and at week 2, 4 and follow-up.
Neck pain intensity was assessed with a Visual Analogue Scale (VAS) to measure the amount of pain experienced by a subject from both groups on a continuum from 0 to 100 mm. Scores can range from 0 (no pain) to 100 (worst imaginable pain)19,20. This method has been proven to be a reliable, generalizable and internally consistent measure of clinical and experimental neck pain
次要结局
- Cervical range of motion (CROM)(At baseline and at week 2 and week 4.)
- Cervical lordosis Cobb angle(At baseline and at week 4.)
- Hospital anxiety and depression scale(At baseline and at week 4 and follow-up.)
研究者
JOSE VICENTE TOLEDO MARHUENDA
Principal Investigator
Universidad Miguel Hernandez de Elche