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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04812678

Enrollment

188

Registered

2021-03-24

Start date

2021-05-01

Completion date

2023-09-06

Last updated

2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low Back Pain, DBM Fasciatherapy, Physiotherapy, Manual Therapy, Fascia

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.

Interventions

PROCEDUREFasciatherapy

Fasciatherapy, with manual therapy and/or gestual therapy.

PROCEDUREPhysiotherapy

Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Intensity	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)

Secondary

Measure	Time frame	Description
Evaluation of State of Anxiety	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)
Analgesic Consumption	1st session (start of the study for the patient)	Evaluation of analgesic consumption (interview of the patient)
Change in the Quality of Life - Physical Score	Before the 1st session	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 the Quality of Life - Mental Score	Before the 1st session	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	Before the 1st session	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)
Change in Functional Abilities - Professional and Leisure Activities	Before the 1st session	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 Functional Abilities - Anxiety and Depression	Before the 1st session	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 Functional Abilities - Sociability	Before the 1st session	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 Functional Abilities - Daily Activities	Before the 1st session	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)

Countries

France

Participant flow

Participants by arm

Arm	Count
Active Comparator: Physiotherapy Procedure: Physiotherapy Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold. Other Names: Physical Therapy	63
Experimental: Physiotherapy and Fasciatherapy 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 Names: Physical Therapy	62
Experimental: Fasciatherapy Procedure: Fasciatherapy Fasciatherapy, with manual therapy and/or gestual therapy. Other Names: DBM Fasciatherapy Danis Bois Method Fasciatherapy	63
Total	188

Baseline characteristics

Characteristic	Experimental: Physiotherapy and Fasciatherapy	Experimental: Fasciatherapy	Total	Active Comparator: Physiotherapy
Age, Continuous	45.8 years STANDARD_DEVIATION 7.7	47.6 years STANDARD_DEVIATION 7.1	46.7 years STANDARD_DEVIATION 7.6	46.7 years STANDARD_DEVIATION 7.9
Race and Ethnicity Not Collected	—	—	0 Participants	—
Sex: Female, Male Female	45 Participants	38 Participants	124 Participants	41 Participants
Sex: Female, Male Male	17 Participants	25 Participants	64 Participants	22 Participants
Star Back outil Triant	4.63 units on a scale STANDARD_DEVIATION 2.09	3.94 units on a scale STANDARD_DEVIATION 1.91	4.3 units on a scale STANDARD_DEVIATION 1.98	4.35 units on a scale STANDARD_DEVIATION 1.93

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 63	0 / 62	0 / 63
other Total, other adverse events	0 / 63	0 / 62	0 / 63
serious Total, serious adverse events	0 / 63	0 / 62	0 / 63