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

NCT04812678 | Completed Results

• 1 other identifier: FF2021
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; DBM Fasciatherapy; Physiotherapy; Manual Therapy; Fascia

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (29)

• 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)

Study Arms (3)

Physiotherapy

ACTIVE COMPARATOR

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

Procedure: Physiotherapy

Physiotherapy and Fasciatherapy

EXPERIMENTAL

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

Procedure: Fasciatherapy; Procedure: Physiotherapy

Fasciatherapy

EXPERIMENTAL

Fasciatherapy Danis Bois Method

Procedure: Fasciatherapy

Interventions

Fasciatherapy PROCEDURE

Fasciatherapy, with manual therapy and/or gestual therapy.

Also known as: DBM Fasciatherapy, Danis Bois Method Fasciatherapy

Fasciatherapy; Physiotherapy and Fasciatherapy

Physiotherapy PROCEDURE

Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.

Also known as: Physical Therapy

Physiotherapy; Physiotherapy and Fasciatherapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FasciaFrance: lead
• University Fernando Pessoa: collaborator

Study Sites (1)

FasciaFrance

Clermont-Ferrand, 63000, France

Location

Related Publications (9)

• 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.

  PMID: 24108286 BACKGROUND

• 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.

  PMID: 9540121 BACKGROUND

• 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.

  PMID: 9817119 BACKGROUND

• 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.

  PMID: 2524890 BACKGROUND

• 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;

  BACKGROUND

• 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.

  PMID: 6602967 BACKGROUND

• Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.

  BACKGROUND

• 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.

  PMID: 28584816 BACKGROUND

• 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.

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Limitations and Caveats

This study confirms the need to develop clinical research into fascia therapies for musculoskeletal disorders. A study could be carried out to verify the durability of the effects obtained, with assessments at 6 months and 1 year. Another study could be carried out using the same criteria and in comparison with other fascia therapies.

Results Point of Contact

• Title: Dr Bertrand
• Organization: FasciaFrance

isa.bertrand.cerap@gmail.com

+33682308609

Study Officials

• Christian Courraud, PhD, PT

  Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: May 1, 2021
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)