Clinical trial NCT04812678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
DBM Fasciatherapy
Physiotherapy
Manual Therapy
Fascia
Lead sponsor: FasciaFrance
Sponsor class: OTHER
Collaborators: name: University Fernando Pessoa
First posted: 2021-03-24
Enrollment: 188
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Intensity
timeFrame: Before the 1st session (start of the study for the patient)
measure: Pain Intensity
timeFrame: After the 1st session (30 to 45 minutes after the previous measure)
measure: Pain Intensity
timeFrame: Before the 2nd session (within a total timeframe of 3 months)
measure: Pain Intensity
timeFrame: After the 2nd session (30 to 45 minutes after the previous measure)
measure: Pain Intensity
timeFrame: Before the 3rd session (within a total timeframe of 3 months)
measure: Pain Intensity
timeFrame: After the 3rd session (30 to 45 minutes after the previous measure)
measure: Pain Intensity
timeFrame: Before the 4th session (within a total timeframe of 3 months)
measure: Pain Intensity
timeFrame: After the 4th session (30 to 45 minutes after the previous measure)
measure: Pain Intensity
timeFrame: Before the 5th session (within a total timeframe of 3 months)
measure: Pain Intensity
timeFrame: After the 5th session (30 to 45 minutes after the previous measure)
Secondary outcomes:
measure: Change in Trait of Anxiety
timeFrame: Before the 1st session
measure: Evaluation of State of Anxiety
timeFrame: Before the 1st session (start of the study for the patient)
measure: Evaluation of State of Anxiety
timeFrame: After the 1st session (30 to 45 minutes after the previous measure)
measure: Evaluation of State of Anxiety
timeFrame: Before the 2nd session (within a total timeframe of 3 months)
measure: Evaluation of State of Anxiety
timeFrame: After the 2nd session (30 to 45 minutes after the previous measure)
measure: Evaluation of State of Anxiety
timeFrame: Before the 3rd session (within a total timeframe of 3 months)
measure: Evaluation of State of Anxiety
timeFrame: After the 3rd session (30 to 45 minutes after the previous measure)
measure: Evaluation of State of Anxiety
timeFrame: Before the 4th session (within a total timeframe of 3 months)
measure: Evaluation of State of Anxiety
timeFrame: After the 4th session (30 to 45 minutes after the previous measure)
measure: Evaluation of State of Anxiety
timeFrame: Before the 5th session (within a total timeframe of 3 months)
measure: Evaluation of State of Anxiety
timeFrame: After the 5th session (30 to 45 minutes after the previous measure)
measure: Analgesic Consumption
timeFrame: 1st session (start of the study for the patient)
measure: Analgesic Consumption
timeFrame: 2nd session (within a total timeframe of 3 months)
measure: Analgesic Consumption
timeFrame: 3rd session (within a total timeframe of 3 months)
measure: Analgesic Consumption
timeFrame: 4th session (within a total timeframe of 3 months)
measure: Analgesic Consumption
timeFrame: 5th session (within a total timeframe of 3 months)
measure: Change in Trait of Anxiety
timeFrame: After the last (5st) session, in a timeframe of 3 months
measure: Change in the Quality of Life - Physical Score
timeFrame: Before the 1st session
measure: Change in the Quality of Life - Physical Score
timeFrame: After the 5st session
measure: Change in the Quality of Life - Mental Score
timeFrame: Before the 1st session
measure: Change in the Quality of Life - Mental Score
timeFrame: After the 5st session
measure: Change in Functional Abilities - Daily Activities
timeFrame: Before the 1st session
measure: Change in Functional Abilities - Daily Activities
timeFrame: After the 5st session
measure: Change in Functional Abilities - Professional and Leisure Activities
timeFrame: Before the 1st session
measure: Change in Functional Abilities - Professional and Leisure Activities
timeFrame: After the 5st session
measure: Change in Functional Abilities - Anxiety and Depression
timeFrame: Before the 1st session
measure: Change in Functional Abilities - Anxiety and Depression
timeFrame: After the 5st session
measure: Change in Functional Abilities - Sociability
timeFrame: Before the 1st session
measure: Change in Functional Abilities - Sociability
timeFrame: After the 5st session
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: FasciaFrance
Study officials:
affiliation: Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa
name: Christian Courraud, PhD, PT
role: STUDY_DIRECTOR
References:
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.
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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.
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.