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| Name | Class |
|---|---|
| University Fernando Pessoa | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy | Active Comparator | Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines |
|
| Physiotherapy and Fasciatherapy | Experimental | Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method |
|
| Fasciatherapy | Experimental | Fasciatherapy Danis Bois Method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasciatherapy | Procedure | Fasciatherapy, with manual therapy and/or gestual therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | 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) | 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) | 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) | 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) | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Before the 1st session |
| Evaluation of State of Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Courraud, PhD, PT | Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FasciaFrance | Clermont-Ferrand | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24108286 | Background | 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. | |
| 9540121 | Background |
| Label | URL |
|---|---|
| French Haute Autorité de Santé guidelines for the treatment of non-specific Low Back Pain | View source |
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No IPD sharing
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Physiotherapy | Procedure: Physiotherapy Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold. Other Names: Physical Therapy |
| FG001 | 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 |
| FG002 | Experimental: Fasciatherapy | Procedure: Fasciatherapy Fasciatherapy, with manual therapy and/or gestual therapy. Other Names: DBM Fasciatherapy Danis Bois Method Fasciatherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Physiotherapy | Procedure: Physiotherapy Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold. Other Names: Physical Therapy |
| BG001 | Experimental: Physiotherapy and Fasciatherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session (start of the study for the patient) |
|
16 months
There was no risk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: Physiotherapy | Procedure: Physiotherapy Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold. Other Names: Physical Therapy |
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This study confirms the need to develop clinical research into fascia therapies for musculoskeletal disorders. A study could be carried out to verify the durability of the effects obtained, with assessments at 6 months and 1 year. Another study could be carried out using the same criteria and in comparison with other fascia therapies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Bertrand | FasciaFrance | +33682308609 | isa.bertrand.cerap@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2022 | Dec 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physiotherapy | Procedure | Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold. |
|
|
| 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) | 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) | 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) | 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)
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | After the 5th session (30 to 45 minutes after the previous measure) |
| Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | 1st session (start of the study for the patient) |
| Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | 2nd session (within a total timeframe of 3 months) |
| Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | 3rd session (within a total timeframe of 3 months) |
| Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | 4th session (within a total timeframe of 3 months) |
| Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | After the 5st session |
| Marty M, Blotman F, Avouac B, Rozenberg S, Valat JP. Validation of the French version of the Dallas Pain Questionnaire in chronic low back pain patients. Rev Rhum Engl Ed. 1998 Feb;65(2):126-34. |
| 9817119 | Background | Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6. |
| 2524890 | Background | Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6. doi: 10.1097/00007632-198905000-00007. |
| Background | Ware J, Kolinski M, Keller S. How to score the SF-12 physical and mental health summaries: a user's manual. Boston: The Health Institute, New England Medical Centre, Boston, MA. 1995; |
| 6602967 | Background | Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X. |
| Background | Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6. |
| 28584816 | Background | 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. |
| Background | 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. |
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 |
| BG002 | Experimental: Fasciatherapy | Procedure: Fasciatherapy Fasciatherapy, with manual therapy and/or gestual therapy. Other Names: DBM Fasciatherapy Danis Bois Method Fasciatherapy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Star Back outil Triant | five questions: 1. fear, 2. anxiety, 3. catastrophizing, 4. feeling depressed, and 5. embarrassment. four questions on physical risk factors for poorer prognosis: 1. referred leg pain, 2. neck/shoulder pain, 3. inability to walk, and 4. difficulty dressing. The overall score ranges from 0 to 9 (best to worst), and divides the population into groups with a low, medium and high risk of a poorer prognosis. global score ≤3, low prognostic risk. combined global score ≥4, medium prognostic risk global score ≥7, high-risk category. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Experimental: Fasciatherapy | Procedure: Fasciatherapy Fasciatherapy, with manual therapy and/or gestual therapy. Other Names: DBM Fasciatherapy Danis Bois Method Fasciatherapy |
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | After the 1st session (30 to 45 minutes after the previous measure) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | Before the 2nd session (within a total timeframe of 3 months) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | After the 2nd session (30 to 45 minutes after the previous measure) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | Before the 3rd session (within a total timeframe of 3 months) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | After the 3rd session (30 to 45 minutes after the previous measure) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | Before the 4th session (within a total timeframe of 3 months) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | After the 4th session (30 to 45 minutes after the previous measure) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | Before the 5th session (within a total timeframe of 3 months) |
|
|
|
| Primary | Pain Intensity | Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | After the 5th session (30 to 45 minutes after the previous measure) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | Before the 1st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session (start of the study for the patient) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 1st session (30 to 45 minutes after the previous measure) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 2nd session (within a total timeframe of 3 months) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 2nd session (30 to 45 minutes after the previous measure) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 3rd session (within a total timeframe of 3 months) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 3rd session (30 to 45 minutes after the previous measure) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 4th session (within a total timeframe of 3 months) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 4th session (30 to 45 minutes after the previous measure) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 5th session (within a total timeframe of 3 months) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5th session (30 to 45 minutes after the previous measure) |
|
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| Secondary | Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | Posted | Number | participants | 1st session (start of the study for the patient) |
|
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| Secondary | Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | Posted | Number | participants | 2nd session (within a total timeframe of 3 months) |
|
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| Secondary | Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | Posted | Number | participants | 3rd session (within a total timeframe of 3 months) |
|
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| Secondary | Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | Posted | Number | participants | 4th session (within a total timeframe of 3 months) |
|
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| Secondary | Analgesic Consumption | Evaluation of analgesic consumption (interview of the patient) | Posted | Number | participants | 5th session (within a total timeframe of 3 months) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | After the last (5st) session, in a timeframe of 3 months |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5st session |
|
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| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Before the 1st session |
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| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | After the 5st session |
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| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | 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 | 0 | 62 | 0 | 62 | 0 | 62 |
| EG002 | Experimental: Fasciatherapy | Procedure: Fasciatherapy Fasciatherapy, with manual therapy and/or gestual therapy. Other Names: DBM Fasciatherapy Danis Bois Method Fasciatherapy | 0 | 63 | 0 | 63 | 0 | 63 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Male |
|