Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Neck and Low Back Pain
研究概览
简要总结
Objective:
To compare the effectiveness of thoracic thrust manipulation, together with massages techniques and stretching, between people with neck pain versus people with low back pain.
Methods:
The research will be performed from August 2021 to October 2021 at the University of Alcala de Henares. (Madrid)
A minimum of forty-six (46) volunteers will participate in this research, and they will be divided in two groups of twenty-three (23). One group will be formed by candidates suffering from neck pain (group A) and the other one by candidate with low back pain (group B).
Both groups will receive the same treatment and specific stretching exercises as applicable in accordance to the pain area, e.g.: group A will get the massage and the stretching exercises more suitable for the neck pain and group B the same but for the low back pain. Nevertheless both groups will receive the same technical thrust manipulation in thoracic area.
All these treatments will be applied of the volunteers at the University of Alcalá.
The treatment includes the following activities:
- Twenty (20) minutes massage in the pain area, as applicable.
- Technical thrust manipulation in thoracic area.
- Ten (10) minutes stretching in accordance to the pain area treated. The stretching shall be repeated twice a week by each volunteer.
A total of six (6) sessions will be carried out during six (6) weeks, one session per week.
Pain, disability, kinesiophobia, HRQoL will be assessed as follow:
- Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
- Between third and fourth session.
- After sixth session.
- Four weeks after sixth session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age between 18 and 65 years
- •Non-specific neck/low back pain for the last three (3) months before the first session.
排除标准
- •Previous surgery in the areas covered by this research (neck and/or low back)
- •Red flags: Cancer or tumor, fracture...
- •Scoliosis or osteoporosis
- •Neck or low back pain with radiculopathy symptoms
- •Central nervous system involvement
- •Fear to manipulation
- •Neck pain associated with whiplash injuries on the last six (6) months
- •Pregnant women
- •Not understand, write and speak Spanish fluently
结局指标
主要结局
Change in Neck and Low Back Pain
时间窗: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
using a Visual Analogue Scale (VAS) from 0 to 10
次要结局
- Change in Neck Pain related disability(Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement)
- Change in kinesiophobia(Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement)
- Change in Health related quality of life (HRQoL)(Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement)
- Change in Low Back Pain related disability(Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement)
研究者
Alexander Achalandabaso
Principal investigator
University of Jaén