Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
This study is a double-blind randomized clinical trial with two arms which aims to study the effects of diaphragmatic treatment in patients with nonspecific low back pain.
Low back pain has a great importance in today's society, and it is therefore important to develop an effective treatment for this condition. People with chronic nonspecific low back pain, can present respiratory disorders and get anxiety states, affecting mainly the diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be part of the development of chronic low back pain. Although clinical practice guidelines for chronic low back pain have been developed, it hasn't been explored before a physiotherapy treatment especially aimed at a diaphragmatic treatment.
A double-blind randomized clinical trial with two arms will be used for this purpose, 64 patients with nonspecific low back pain referred from different hospitals of Castellón will be randomized into two groups:
- Diaphragmatic intervention with osteopathic manual therapy treatment (D).
- Diaphragmatic intervention with placebo treatment group (P).
An osteopathic manual therapy protocol for the treatment of back pain including techniques for the diaphragm muscle will be applied to the patients in group D, in a total of 5 sessions. For patients in group P, the same protocol will be performed on the diaphragm but with placebo treatment techniques.
The study focuses on the analysis of the following variables: scores on the questionnaires:
- Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).
- Fear Avoidance: (FABQ)
- Disability: Oswestry Disability Index and Roland-Morris
- Anxiety: HADS: (Hospital Anxiety and Depression Scale)
- Catastropizing: PCS (Pain Catastropizing Scale)
- Satisfaction with treatment (Escala de Satisfacción con el tratamiento)
The results of these pre-intervention and post-intervention variables will be compared between the two groups in the first session, in the fourth session and in the first and third month after the first intervention. The VAS score will also be assessed in the second and third session.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low back pain for more than 3 months
排除标准
- •vertebra fracture
- •systemic disease
- •spinal surgery
- •degenerative articular disease
- •acute soft tissue inflammation
- •radiculopathy
- •structural spine deformities
- •pregnancy
- •mental disease
- •dermatologic disease
- •rejection to manual contact
研究组 & 干预措施
diaphragmatic treatment
Subjects in this arm receive different manual techniques for the low back pain and diaphragmatic treatment.
干预措施: manual therapy with diaphragmatic treatment (Other)
Placebo
Subjects in this arm receive different manual techniques for the low back pain and a sham diaphragmatic treatment.
干预措施: Placebo treatment (Other)
结局指标
主要结局
Pain
时间窗: 4 weeks
Short form McGill Pain Questionnaire
Disability
时间窗: 4 weeks
Oswestry Disability Index
次要结局
- Fear Avoidance Beliefs Questionnaire(4 weeks)
- Hospital Anxiety and Depression Scale(4 weeks)
- Pain Catastropizing Scale(4 weeks)
- Satisfaction with treatment Questionnaire(4 weeks)
研究者
Eva Segura Ortí
PhD
Cardenal Herrera University