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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Physiotherapy; Procedure: Fasciatherapy

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • FasciaFrance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physiotherapy; Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines	Procedure: Physiotherapy; Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.; Other Names: Physical Therapy
Experimental: Physiotherapy and Fasciatherapy; Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method	Procedure: Physiotherapy; Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.; Other Names: Physical Therapy; Procedure: Fasciatherapy; Fasciatherapy, with manual therapy and/or gestual therapy.; Other Names: DBM Fasciatherapy; Danis Bois Method Fasciatherapy
Experimental: Fasciatherapy; Fasciatherapy Danis Bois Method	Procedure: Fasciatherapy; Fasciatherapy, with manual therapy and/or gestual therapy.; Other Names: DBM Fasciatherapy; Danis Bois Method Fasciatherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 1st session (start of the study for the patient)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 1st session (30 to 45 minutes after the previous measure)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 2nd session (within a total timeframe of 3 months)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 2nd session (30 to 45 minutes after the previous measure)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 3rd session (within a total timeframe of 3 months)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 3rd session (30 to 45 minutes after the previous measure)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 4th session (within a total timeframe of 3 months)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 4th session (30 to 45 minutes after the previous measure)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 5th session (within a total timeframe of 3 months)
Pain Intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 5th session (30 to 45 minutes after the previous measure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Trait of Anxiety	Evaluation of the change in trait of anxiety with State Trait Inventory Anxiety questionnaire, part Y-B: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 1st session
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 1st session (start of the study for the patient)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 1st session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 2nd session (within a total timeframe of 3 months)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 2nd session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 3rd session (within a total timeframe of 3 months)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 3rd session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 4th session (within a total timeframe of 3 months)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 4th session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 5th session (within a total timeframe of 3 months)
Evaluation of State of Anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 5th session (30 to 45 minutes after the previous measure)
Analgesic Consumption	Evaluation of analgesic consumption (interview of the patient)	1st session (start of the study for the patient)
Analgesic Consumption	Evaluation of analgesic consumption (interview of the patient)	2nd session (within a total timeframe of 3 months)
Analgesic Consumption	Evaluation of analgesic consumption (interview of the patient)	3rd session (within a total timeframe of 3 months)
Analgesic Consumption	Evaluation of analgesic consumption (interview of the patient)	4th session (within a total timeframe of 3 months)
Analgesic Consumption	Evaluation of analgesic consumption (interview of the patient)	5th session (within a total timeframe of 3 months)
Change in Trait of Anxiety	Evaluation of the change in trait of anxiety with State Trait Inventory Anxiety questionnaire, part Y-B: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the last (5st) session, in a timeframe of 3 months
Change in the Quality of Life - Physical Score	Assessment of the change in the quality of life with the French version of the short version (SF-12) of "Short Form with 36 questions" (SF-36) questionnaire: scale from 0 (bad) to 100 (best)	Before the 1st session
Change in the Quality of Life - Physical Score	Assessment of the change in the quality of life with the French version of the short version (SF-12) of "Short Form with 36 questions" (SF-36) questionnaire: scale from 0 (bad) to 100 (best)	After the 5st session
Change in the Quality of Life - Mental Score	Assessment of the change in the quality of life with the French version of the short version (SF-12) of "Short Form with 36 questions" (SF-36) questionnaire: scale from 0 (bad) to 100 (best)	Before the 1st session
Change in the Quality of Life - Mental Score	Assessment of the change in the quality of life with the French version of the short version (SF-12) of "Short Form with 36 questions" (SF-36) questionnaire: scale from 0 (bad) to 100 (best)	After the 5st session
Change in Functional Abilities - Daily Activities	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	Before the 1st session
Change in Functional Abilities - Daily Activities	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	After the 5st session
Change in Functional Abilities - Professional and Leisure Activities	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	Before the 1st session
Change in Functional Abilities - Professional and Leisure Activities	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	After the 5st session
Change in Functional Abilities - Anxiety and Depression	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	Before the 1st session
Change in Functional Abilities - Anxiety and Depression	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	After the 5st session
Change in Functional Abilities - Sociability	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	Before the 1st session
Change in Functional Abilities - Sociability	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	After the 5st session

Collaborators and Investigators

• Sponsor: FasciaFrance
• Collaborators: University Fernando Pessoa
• Investigators: Study Director: Christian Courraud, PhD, PT, Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Rev Rhum Engl Ed 1998 May;65(5):363.
• 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.

Helpful Links

• French Haute Autorité de Santé guidelines for the treatment of non-specific Low Back Pain

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 20, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Low Back Pain; Fascia; Physiotherapy; Manual Therapy; DBM Fasciatherapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FF2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No