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Completed

NCT Number: NCT04812678

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FasciaFrance

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasciatherapy

Procedure

Fasciatherapy, with manual therapy and/or gestual therapy.

Other names: DBM Fasciatherapy, Danis Bois Method Fasciatherapy

physiotherapy

Procedure

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

Other names: Physical Therapy

Primary outcomes

  1. Pain Intensity

    Time frame: 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)

  2. Pain Intensity

    Time frame: After the 1st session (30 to 45 minutes after the previous measure)

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

  3. Pain Intensity

    Time frame: Before the 2nd session (within a total timeframe of 3 months)

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

  4. Pain Intensity

    Time frame: After the 2nd session (30 to 45 minutes after the previous measure)

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

  5. Pain Intensity

    Time frame: Before the 3rd session (within a total timeframe of 3 months)

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

  6. Pain Intensity

    Time frame: After the 3rd session (30 to 45 minutes after the previous measure)

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

  7. Pain Intensity

    Time frame: Before the 4th session (within a total timeframe of 3 months)

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

  8. Pain Intensity

    Time frame: After the 4th session (30 to 45 minutes after the previous measure)

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

  9. Pain Intensity

    Time frame: Before the 5th session (within a total timeframe of 3 months)

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

  10. Pain Intensity

    Time frame: After the 5th session (30 to 45 minutes after the previous measure)

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

Secondary outcomes

  1. Change in Trait of Anxiety

    Time frame: 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)

  2. Evaluation of State of Anxiety

    Time frame: 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)

  3. Evaluation of State of Anxiety

    Time frame: After the 1st session (30 to 45 minutes after the previous measure)

    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)

  4. Evaluation of State of Anxiety

    Time frame: Before the 2nd session (within a total timeframe of 3 months)

    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)

  5. Evaluation of State of Anxiety

    Time frame: After the 2nd session (30 to 45 minutes after the previous measure)

    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)

  6. Evaluation of State of Anxiety

    Time frame: Before the 3rd session (within a total timeframe of 3 months)

    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)

  7. Evaluation of State of Anxiety

    Time frame: After the 3rd session (30 to 45 minutes after the previous measure)

    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)

  8. Evaluation of State of Anxiety

    Time frame: Before the 4th session (within a total timeframe of 3 months)

    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)

  9. Evaluation of State of Anxiety

    Time frame: After the 4th session (30 to 45 minutes after the previous measure)

    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)

  10. Evaluation of State of Anxiety

    Time frame: Before the 5th session (within a total timeframe of 3 months)

    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)

  11. Evaluation of State of Anxiety

    Time frame: After the 5th session (30 to 45 minutes after the previous measure)

    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)

  12. Analgesic Consumption

    Time frame: 1st session (start of the study for the patient)

    Evaluation of analgesic consumption (interview of the patient)

  13. Analgesic Consumption

    Time frame: 2nd session (within a total timeframe of 3 months)

    Evaluation of analgesic consumption (interview of the patient)

  14. Analgesic Consumption

    Time frame: 3rd session (within a total timeframe of 3 months)

    Evaluation of analgesic consumption (interview of the patient)

  15. Analgesic Consumption

    Time frame: 4th session (within a total timeframe of 3 months)

    Evaluation of analgesic consumption (interview of the patient)

  16. Analgesic Consumption

    Time frame: 5th session (within a total timeframe of 3 months)

    Evaluation of analgesic consumption (interview of the patient)

  17. Change in Trait of Anxiety

    Time frame: After the last (5st) session, in a timeframe of 3 months

    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)

  18. Change in the Quality of Life - Physical Score

    Time frame: 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)

  19. Change in the Quality of Life - Physical Score

    Time frame: After the 5st 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)

  20. Change in the Quality of Life - Mental Score

    Time frame: 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)

  21. Change in the Quality of Life - Mental Score

    Time frame: After the 5st 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)

  22. Change in Functional Abilities - Daily Activities

    Time frame: 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)

  23. Change in Functional Abilities - Daily Activities

    Time frame: After the 5st 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)

  24. Change in Functional Abilities - Professional and Leisure Activities

    Time frame: 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)

  25. Change in Functional Abilities - Professional and Leisure Activities

    Time frame: After the 5st 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)

  26. Change in Functional Abilities - Anxiety and Depression

    Time frame: 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)

  27. Change in Functional Abilities - Anxiety and Depression

    Time frame: After the 5st 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)

  28. Change in Functional Abilities - Sociability

    Time frame: 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)

  29. Change in Functional Abilities - Sociability

    Time frame: After the 5st 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)

Sponsors and collaborators

Lead sponsor

FasciaFrance

Other

Collaborators

  • University Fernando Pessoa

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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