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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    180
  • sponsor
    FasciaFrance
Updated on 14 May 2021

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-Kinsithrapeutes.

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.

Details
Condition Low Back Pain, Lower Back Pain, Back Pain, Chronic Back Pain, Chronic Back Pain, Lower Back Pain, lumbago
Treatment Physiotherapy, Fasciatherapy
Clinical Study IdentifierNCT04812678
SponsorFasciaFrance
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

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 Autorit de Sant 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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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