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

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ClinicalTrials.gov Identifier: NCT04812678
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
University Fernando Pessoa
Information provided by (Responsible Party):
FasciaFrance

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Fasciatherapy Procedure: Physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: Physical Therapy

Experimental: Physiotherapy and Fasciatherapy
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
Procedure: Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
Other Names:
  • DBM Fasciatherapy
  • Danis Bois Method Fasciatherapy

Procedure: Physiotherapy
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
Other Name: Physical Therapy

Experimental: Fasciatherapy
Fasciatherapy Danis Bois Method
Procedure: Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
Other Names:
  • DBM Fasciatherapy
  • Danis Bois Method Fasciatherapy




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 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)

  2. Pain intensity [ Time Frame: 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)

  3. Pain intensity [ Time Frame: 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)

  4. Pain intensity [ Time Frame: 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)

  5. Pain intensity [ Time Frame: 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)

  6. Pain intensity [ Time Frame: 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)

  7. Pain intensity [ Time Frame: 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)

  8. Pain intensity [ Time Frame: 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)

  9. Pain intensity [ Time Frame: 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)

  10. Pain intensity [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in functional abilities [ Time Frame: Before the 1st session and after the last (5st) session, in a timeframe of 3 months ]
    Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)

  2. Change in the quality of life [ Time Frame: Before the 1st session and after the last (5st) session, in a timeframe of 3 months ]
    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)

  3. Change in trait of anxiety [ Time Frame: Before the 1st session and after the last (5st) session, in a timeframe of 3 months ]
    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)

  4. Evaluation of state of anxiety [ Time Frame: Before the 1st session (start of the study for the patient) ]
    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)

  5. Evaluation of state of anxiety [ Time Frame: After the 1st session (30 to 45 minutes after the previous measure) ]
    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)

  6. Evaluation of state of anxiety [ Time Frame: Before the 2nd session (within a total timeframe of 3 months) ]
    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)

  7. Evaluation of state of anxiety [ Time Frame: After the 2nd session (30 to 45 minutes after the previous measure) ]
    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)

  8. Evaluation of state of anxiety [ Time Frame: Before the 3rd session (within a total timeframe of 3 months) ]
    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)

  9. Evaluation of state of anxiety [ Time Frame: After the 3rd session (30 to 45 minutes after the previous measure) ]
    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)

  10. Evaluation of state of anxiety [ Time Frame: Before the 4th session (within a total timeframe of 3 months) ]
    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)

  11. Evaluation of state of anxiety [ Time Frame: After the 4th session (30 to 45 minutes after the previous measure) ]
    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)

  12. Evaluation of state of anxiety [ Time Frame: Before the 5th session (within a total timeframe of 3 months) ]
    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)

  13. Evaluation of state of anxiety [ Time Frame: After the 5th session (30 to 45 minutes after the previous measure) ]
    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)

  14. Drug consumption [ Time Frame: 1st session (start of the study for the patient) ]
    Evaluation of drug consumption (interview of the patient)

  15. Drug consumption [ Time Frame: 2nd session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)

  16. Drug consumption [ Time Frame: 3rd session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)

  17. Drug consumption [ Time Frame: 4th session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)

  18. Drug consumption [ Time Frame: 5th session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812678


Contacts
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Contact: Cyril Dupuis, Ms, PT +33473550055 cyril.h.dupuis@gmail.com
Contact: Isabelle Bertrand, PhD, PT isabelle.bertrand@cerap.org

Locations
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France
FasciaFrance Recruiting
Clermont-Ferrand, France, 63000
Contact: Isabelle Bertrand, PhD, PT       isabelle.bertrand@cerap.org   
Sponsors and Collaborators
FasciaFrance
University Fernando Pessoa
Investigators
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Study Director: Christian Courraud, PhD, PT Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa
Additional Information:
Publications:
Marty M, Blotman F, Avouac B, Rozenberg S, Valat J-P. Validation de la version française de l'échelle de Dallas chez les patients lombalgiques chroniques. Revue du rhumatisme (Ed française). 1998;65(2):139-47.
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;
Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.
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.

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Responsible Party: FasciaFrance
ClinicalTrials.gov Identifier: NCT04812678    
Other Study ID Numbers: FF2021
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FasciaFrance:
Low Back Pain
DBM Fasciatherapy
Physiotherapy
Manual Therapy
Fascia
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations