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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

Tracking Information
First Submitted Date  ICMJE March 17, 2021
First Posted Date  ICMJE March 24, 2021
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2021)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2021)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Drug consumption [ Time Frame: 1st session (start of the study for the patient) ]
    Evaluation of drug consumption (interview of the patient)
  • Drug consumption [ Time Frame: 2nd session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)
  • Drug consumption [ Time Frame: 3rd session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)
  • Drug consumption [ Time Frame: 4th session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)
  • Drug consumption [ Time Frame: 5th session (within a total timeframe of 3 months) ]
    Evaluation of drug consumption (interview of the patient)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of DBM Fasciatherapy for Patients Suffering From Chronic Low Back Pain
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Physiotherapy
    Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines
    Intervention: Procedure: Physiotherapy
  • Experimental: Physiotherapy and Fasciatherapy
    Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
    Interventions:
    • Procedure: Fasciatherapy
    • Procedure: Physiotherapy
  • Experimental: Fasciatherapy
    Fasciatherapy Danis Bois Method
    Intervention: Procedure: Fasciatherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2021)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cyril Dupuis, Ms, PT +33473550055 cyril.h.dupuis@gmail.com
Contact: Isabelle Bertrand, PhD, PT isabelle.bertrand@cerap.org
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04812678
Other Study ID Numbers  ICMJE FF2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD sharing
Responsible Party FasciaFrance
Study Sponsor  ICMJE FasciaFrance
Collaborators  ICMJE University Fernando Pessoa
Investigators  ICMJE
Study Director: Christian Courraud, PhD, PT Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa
PRS Account FasciaFrance
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP