Efficacy of DBM Fasciatherapy for Patients Suffering From Chronic Low Back Pain

FasciaFrance

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Physiotherapy; Procedure: Fasciatherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04812678

FF2021

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 3 patient groups

Physiotherapy

Active Comparator group

Description:

Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines

Treatment:

Procedure: Physiotherapy

Physiotherapy and Fasciatherapy

Experimental group

Description:

Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method

Treatment:

Procedure: Fasciatherapy

Procedure: Physiotherapy

Fasciatherapy

Experimental group

Description:

Fasciatherapy Danis Bois Method

Treatment:

Procedure: Fasciatherapy