Efficacy of DBM Fasciatherapy for Patients Suffering From Chronic Low Back Pain
NCT ID: NCT04812678
Last Updated: 2025-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
188 participants
INTERVENTIONAL
2021-05-01
2023-09-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Physiotherapy
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines
Physiotherapy
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
Physiotherapy and Fasciatherapy
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
Physiotherapy
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
Fasciatherapy
Fasciatherapy Danis Bois Method
Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
Interventions
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Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
Physiotherapy
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
60 Years
ALL
No
Sponsors
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University Fernando Pessoa
OTHER
FasciaFrance
OTHER
Responsible Party
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Principal Investigators
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Christian Courraud, PhD, PT
Role: STUDY_DIRECTOR
Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa
Locations
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FasciaFrance
Clermont-Ferrand, , France
Countries
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References
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Bruyere O, Demoulin M, Beaudart C, Hill JC, Maquet D, Genevay S, Mahieu G, Reginster JY, Crielaard JM, Demoulin C. Validity and reliability of the French version of the STarT Back screening tool for patients with low back pain. Spine (Phila Pa 1976). 2014 Jan 15;39(2):E123-8. doi: 10.1097/BRS.0000000000000062.
Marty M, Blotman F, Avouac B, Rozenberg S, Valat JP. Validation of the French version of the Dallas Pain Questionnaire in chronic low back pain patients. Rev Rhum Engl Ed. 1998 Feb;65(2):126-34.
Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.
Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6. doi: 10.1097/00007632-198905000-00007.
Ware J, Kolinski M, Keller S. How to score the SF-12 physical and mental health summaries: a user's manual. Boston: The Health Institute, New England Medical Centre, Boston, MA. 1995;
Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.
Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.
Wilke J, Schleip R, Klingler W, Stecco C. The Lumbodorsal Fascia as a Potential Source of Low Back Pain: A Narrative Review. Biomed Res Int. 2017;2017:5349620. doi: 10.1155/2017/5349620. Epub 2017 May 11.
Courraud C, Bois D, Lieutaud A. Apports de la pratique de la fasciathérapie à l'exercice de la physiothérapie: le point de vue des praticiens. Mains Libres. 2016;(3):49-58.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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French Haute Autorité de Santé guidelines for the treatment of non-specific Low Back Pain
Other Identifiers
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FF2021
Identifier Type: -
Identifier Source: org_study_id
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