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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Fasciatherapy
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 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) | Before the 1st session and after the last (5st) session, in a timeframe of 3 months | 
| 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) | Before the 1st session and after the last (5st) session, in a 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) | Before the 1st session and after the last (5st) session, in a 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) | 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) | 
| Drug consumption | Evaluation of drug consumption (interview of the patient) | 1st session (start of the study for the patient) | 
| Drug consumption | Evaluation of drug consumption (interview of the patient) | 2nd session (within a total timeframe of 3 months) | 
| Drug consumption | Evaluation of drug consumption (interview of the patient) | 3rd session (within a total timeframe of 3 months) | 
| Drug consumption | Evaluation of drug consumption (interview of the patient) | 4th session (within a total timeframe of 3 months) | 
| Drug consumption | Evaluation of drug consumption (interview of the patient) | 5th session (within a total timeframe of 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, DBM Fasciatherapy, Physiotherapy, Manual Therapy, Fascia