Interest of DBM Fasciatherapy for Physiotherapy in the Care of Patients Suffering From Non-Specific Chronic Low Back Pain: a Cluster Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
Low back pain (LBP) is pain localized below the costal margin and above the inferior gluteal folds. It may be associated with radiculalgia. Non-specific LBP refers to LBP without specific problems such as infection, inflammation, vertebral fracture or cancer. Chronic LBP is a LBP lasting more than 3 months.
The causes of LBP remain unknown. While there are recommendations for physiotherapy, the protocol of care is not well defined. New therapeutic models centered on neurophysiology are replacing biomechanics-based models. New programs centered on patient education and a biopsychosocial approach are emerging.
Research has shown the possible involvement of fascia in LBP and the interest of manual fascia therapies in the treatment of LBP. To date, there are no studies that have shown the effects of fasciatherapy in the treatment of non-specific LBP.
In France, many physiotherapists use this type of treatment and more specifically fasciatherapy. French physiotherapists say that it may improve their management of LBP. Studies on fasciatherapy have highlighted the effects of fasciatherapy in the management of fibromyalgia pain, the treatment of anxiety, malaise and the improvement of body perception. They show the multidimensional actions of fasciatherapy and support its clinical, functional and psychosocial evaluation for LBP.
Fasciatherapy is part of the manual therapies that target their action on the fascial system. This "patient-centered" technique is a biopsychosocial and humanistic approach to health. The manual and gestural approaches of the fascia are part of the Non-Pharmaceutical Interventions field. Fasciatherapy involves manual and gestural interventions, with the objective of restoring the contractile, elastic and movement properties of the fascia in order to provide relief, improve function and quality of life for patients.
In France, fasciatherapy is not part of recommendations and is not recognized by the Conseil National de l'Ordre des Masseurs-Kinésithérapeutes.
This study aims to assess the effects of fasciatherapy on LBP and to evaluate how it could contribute to its management for physiotherapists. It is a cluster randomized trial conducted on 180 subjects. Intensity of pain (measured with VAS) is the primary outcome. The secondary outcomes are the impact of LBP on daily life (Dallas Pain Questionnaire), on quality of life (SF-12 questionnaire), on anxiety (STAI questionnaire), and the evolution of drug consumption.
The study will take place in France and the treatment structures will be the practitioners' practice.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First consultation for Low Back Pain with the practitioner
- •Having a diagnostic of chronic non-specific Low Back Pain based on the French Haute Autorité de Santé guidelines (https://www.has-sante.fr/upload/docs/application/pdf/2019-04/fm_lombalgie_v2_2.pdf):
- •excluding specific Low Back Pain (tumor, infection, inflammation, etc.)
- •no red flag
- •Low Back Pain for more than 3 months
- •Having had the French validated version of:
- •evaluation of pain intensity with Visual Analog Scale
- •STarT Back Screening Tool questionnaire
- •Dallas Pain questionnaire
排除标准
- •Specific Low Back Pain (rheumatologist disease, tumoral compression, central neurological pathology, etc.)
- •Psychiatric disorder (apart from the usual co-morbidities of chronic low back pain)
- •Pregnancy or breastfeeding
- •Being under guardianship or curatorship
- •Deprivation of liberty or legal protection measure
- •Being unable to give consent
- •Being unable of fill out a questionnaire
研究组 & 干预措施
Fasciatherapy
Fasciatherapy Danis Bois Method
干预措施: Fasciatherapy (Procedure)
Physiotherapy
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines
干预措施: Physiotherapy (Procedure)
Physiotherapy and Fasciatherapy
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
干预措施: Fasciatherapy (Procedure)
Physiotherapy and Fasciatherapy
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
干预措施: Physiotherapy (Procedure)
结局指标
主要结局
Pain Intensity
时间窗: After the 5th session (30 to 45 minutes after the previous measure)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: Before the 1st session (start of the study for the patient)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: Before the 2nd session (within a total timeframe of 3 months)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: After the 1st session (30 to 45 minutes after the previous measure)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: After the 2nd session (30 to 45 minutes after the previous measure)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: Before the 3rd session (within a total timeframe of 3 months)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: After the 3rd session (30 to 45 minutes after the previous measure)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: Before the 4th session (within a total timeframe of 3 months)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: After the 4th session (30 to 45 minutes after the previous measure)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain Intensity
时间窗: Before the 5th session (within a total timeframe of 3 months)
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
次要结局
- Analgesic Consumption(5th session (within a total timeframe of 3 months))
- Change in Functional Abilities - Daily Activities(After the 5st session)
- Change in Functional Abilities - Sociability(After the 5st session)
- Change in Trait of Anxiety(After the last (5st) session, in a timeframe of 3 months)
- Evaluation of State of Anxiety(After the 5th session (30 to 45 minutes after the previous measure))
- Change in the Quality of Life - Physical Score(After the 5st session)
- Change in the Quality of Life - Mental Score(After the 5st session)
- Change in Functional Abilities - Professional and Leisure Activities(After the 5st session)
- Change in Functional Abilities - Anxiety and Depression(After the 5st session)
- Change in Trait of Anxiety(Before the 1st session)
- Evaluation of State of Anxiety(Before the 1st session (start of the study for the patient))
- Evaluation of State of Anxiety(After the 1st session (30 to 45 minutes after the previous measure))
- Evaluation of State of Anxiety(Before the 2nd session (within a total timeframe of 3 months))
- Evaluation of State of Anxiety(After the 2nd session (30 to 45 minutes after the previous measure))
- Evaluation of State of Anxiety(Before the 3rd session (within a total timeframe of 3 months))
- Evaluation of State of Anxiety(After the 3rd session (30 to 45 minutes after the previous measure))
- Evaluation of State of Anxiety(Before the 4th session (within a total timeframe of 3 months))
- Evaluation of State of Anxiety(After the 4th session (30 to 45 minutes after the previous measure))
- Evaluation of State of Anxiety(Before the 5th session (within a total timeframe of 3 months))
- Analgesic Consumption(1st session (start of the study for the patient))
- Analgesic Consumption(2nd session (within a total timeframe of 3 months))
- Analgesic Consumption(3rd session (within a total timeframe of 3 months))
- Analgesic Consumption(4th session (within a total timeframe of 3 months))
- Change in the Quality of Life - Physical Score(Before the 1st session)
- Change in the Quality of Life - Mental Score(Before the 1st session)
- Change in Functional Abilities - Daily Activities(Before the 1st session)
- Change in Functional Abilities - Professional and Leisure Activities(Before the 1st session)
- Change in Functional Abilities - Anxiety and Depression(Before the 1st session)
- Change in Functional Abilities - Sociability(Before the 1st session)
