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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
188
Fasciatherapy, with manual therapy and/or gestual therapy.
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
FasciaFrance
Clermont-Ferrand, France
Pain Intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: After the 5th session (30 to 45 minutes after the previous measure)
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)
Time frame: Before the 1st session
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: After the 5th session (30 to 45 minutes after the previous measure)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Time frame: 1st session (start of the study for the patient)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Time frame: 2nd session (within a total timeframe of 3 months)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Time frame: 3rd session (within a total timeframe of 3 months)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Time frame: 4th session (within a total timeframe of 3 months)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Time frame: 5th session (within a total 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)
Time frame: After the last (5st) session, in a timeframe of 3 months
Change in the Quality of Life - Physical Score
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)
Time frame: Before the 1st session
Change in the Quality of Life - Physical Score
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)
Time frame: After the 5st session
Change in the Quality of Life - Mental Score
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)
Time frame: Before the 1st session
Change in the Quality of Life - Mental Score
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)
Time frame: After the 5st session
Change in Functional Abilities - Daily Activities
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: Before the 1st session
Change in Functional Abilities - Daily Activities
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: After the 5st session
Change in Functional Abilities - Professional and Leisure Activities
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: Before the 1st session
Change in Functional Abilities - Professional and Leisure Activities
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: After the 5st session
Change in Functional Abilities - Anxiety and Depression
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: Before the 1st session
Change in Functional Abilities - Anxiety and Depression
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: After the 5st session
Change in Functional Abilities - Sociability
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: Before the 1st session
Change in Functional Abilities - Sociability
Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)
Time frame: After the 5st session