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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fasciatherapy
Physiotherapy
Sponsored by
FasciaFrance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, DBM Fasciatherapy, Physiotherapy, Manual Therapy, Fascia

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FasciaFrance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Physiotherapy

Physiotherapy and Fasciatherapy

Fasciatherapy

Arm Description

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

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

Fasciatherapy Danis Bois Method

Outcomes

Primary Outcome Measures

Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Pain intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)

Secondary Outcome Measures

Change in functional abilities
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
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
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
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
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
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
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
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
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
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
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
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
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
Evaluation of drug consumption (interview of the patient)
Drug consumption
Evaluation of drug consumption (interview of the patient)
Drug consumption
Evaluation of drug consumption (interview of the patient)
Drug consumption
Evaluation of drug consumption (interview of the patient)
Drug consumption
Evaluation of drug consumption (interview of the patient)

Full Information

First Posted
March 17, 2021
Last Updated
September 27, 2023
Sponsor
FasciaFrance
Collaborators
University Fernando Pessoa
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1. Study Identification

Unique Protocol Identification Number
NCT04812678
Brief Title
Efficacy of DBM Fasciatherapy for Patients Suffering From Chronic Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 6, 2023 (Actual)
Study Completion Date
September 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FasciaFrance
Collaborators
University Fernando Pessoa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, DBM Fasciatherapy, Physiotherapy, Manual Therapy, Fascia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines
Arm Title
Physiotherapy and Fasciatherapy
Arm Type
Experimental
Arm Description
Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
Arm Title
Fasciatherapy
Arm Type
Experimental
Arm Description
Fasciatherapy Danis Bois Method
Intervention Type
Procedure
Intervention Name(s)
Fasciatherapy
Other Intervention Name(s)
DBM Fasciatherapy, Danis Bois Method Fasciatherapy
Intervention Description
Fasciatherapy, with manual therapy and/or gestual therapy.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Physical Therapy
Intervention Description
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Before the 1st session (start of the study for the patient)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
After the 1st session (30 to 45 minutes after the previous measure)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Before the 2nd session (within a total timeframe of 3 months)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
After the 2nd session (30 to 45 minutes after the previous measure)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Before the 3rd session (within a total timeframe of 3 months)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
After the 3rd session (30 to 45 minutes after the previous measure)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Before the 4th session (within a total timeframe of 3 months)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
After the 4th session (30 to 45 minutes after the previous measure)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Before the 5th session (within a total timeframe of 3 months)
Title
Pain intensity
Description
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time Frame
After the 5th session (30 to 45 minutes after the previous measure)
Secondary Outcome Measure Information:
Title
Change in functional abilities
Description
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time Frame
Before the 1st session and after the last (5st) session, in a timeframe of 3 months
Title
Change in the quality of life
Description
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)
Time Frame
Before the 1st session and after the last (5st) session, in a timeframe of 3 months
Title
Change in trait of anxiety
Description
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)
Time Frame
Before the 1st session and after the last (5st) session, in a timeframe of 3 months
Title
Evaluation of state of anxiety
Description
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)
Time Frame
Before the 1st session (start of the study for the patient)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
After the 1st session (30 to 45 minutes after the previous measure)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
Before the 2nd session (within a total timeframe of 3 months)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
After the 2nd session (30 to 45 minutes after the previous measure)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
Before the 3rd session (within a total timeframe of 3 months)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
After the 3rd session (30 to 45 minutes after the previous measure)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
Before the 4th session (within a total timeframe of 3 months)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
After the 4th session (30 to 45 minutes after the previous measure)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
Before the 5th session (within a total timeframe of 3 months)
Title
Evaluation of state of anxiety
Description
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)
Time Frame
After the 5th session (30 to 45 minutes after the previous measure)
Title
Drug consumption
Description
Evaluation of drug consumption (interview of the patient)
Time Frame
1st session (start of the study for the patient)
Title
Drug consumption
Description
Evaluation of drug consumption (interview of the patient)
Time Frame
2nd session (within a total timeframe of 3 months)
Title
Drug consumption
Description
Evaluation of drug consumption (interview of the patient)
Time Frame
3rd session (within a total timeframe of 3 months)
Title
Drug consumption
Description
Evaluation of drug consumption (interview of the patient)
Time Frame
4th session (within a total timeframe of 3 months)
Title
Drug consumption
Description
Evaluation of drug consumption (interview of the patient)
Time Frame
5th session (within a total timeframe of 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Courraud, PhD, PT
Organizational Affiliation
Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa
Official's Role
Study Director
Facility Information:
Facility Name
FasciaFrance
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD sharing
Citations:
PubMed Identifier
24108286
Citation
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.
Results Reference
background
PubMed Identifier
9540121
Citation
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.
Results Reference
background
PubMed Identifier
9817119
Citation
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.
Results Reference
background
PubMed Identifier
2524890
Citation
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.
Results Reference
background
Citation
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;
Results Reference
background
PubMed Identifier
6602967
Citation
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.
Results Reference
background
Citation
Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.
Results Reference
background
PubMed Identifier
28584816
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
https://www.has-sante.fr/upload/docs/application/pdf/2019-04/fm_lombalgie_v2_2.pdf
Description
French Haute Autorité de Santé guidelines for the treatment of non-specific Low Back Pain

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

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