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

A study testing Fasciatherapy and Physiotherapy in people with Low Back Pain, run by FasciaFrance at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Low Back Pain
What is being tested?: Fasciatherapy and Physiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 188 participants
Where: 1 siteFrance
Study dates: 1 May 2021to 6 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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:

Show all 9Show fewer

evaluation of pain intensity with Visual Analog Scale
STarT Back Screening Tool questionnaire
Dallas Pain questionnaire

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

FasciaFrance
Clermont-Ferrand, 63000

Other trials in France

About this study

Official 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

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.

Conditions: Low Back Pain
Being tested: Fasciatherapy, Physiotherapy
Keywords: Low Back Pain, DBM Fasciatherapy, Physiotherapy, Manual Therapy, Fascia
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FasciatherapyProcedure or surgery
Also called DBM Fasciatherapy, Danis Bois Method Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
PhysiotherapyProcedure or surgery
Also called Physical Therapy
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.

Study groups in NCT04812678
Study group	Role	What they receive
Physiotherapy	Active comparator	Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines Receives: Procedure: Physiotherapy
Physiotherapy and Fasciatherapy	Experimental	Conventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method Receives: Procedure: Fasciatherapy; Procedure: Physiotherapy
Fasciatherapy	Experimental	Fasciatherapy Danis Bois Method Receives: Procedure: Fasciatherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Intensity
Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After the 5th session (30 to 45 minutes after the previous measure)

Secondary outcomes (29)

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After the 5th session (30 to 45 minutes after the previous measure)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Measured: 1st session (start of the study for the patient)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Measured: 2nd session (within a total timeframe of 3 months)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Measured: 3rd session (within a total timeframe of 3 months)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Measured: 4th session (within a total timeframe of 3 months)
Analgesic Consumption
Evaluation of analgesic consumption (interview of the patient)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After the 5st session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20216 Sep 2023

First posted24 Mar 2021
Study start1 May 2021
Primary completion6 Sep 2023
Study completion6 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04812678
Sponsor's protocol ID: FF2021
Status last verified: Feb 2025
First submitted: 17 Mar 2021
Last updated: 24 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No IPD sharing

Publications

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.
PubMed 24108286
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.
PubMed 9540121
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.
PubMed 9817119
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.
PubMed 2524890
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;
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.
PubMed 6602967
Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.
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.
PubMed 28584816
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
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Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04812678
Acronym / sponsor ID: FF2021
Conditions: Low Back Pain
Keywords: Low Back Pain, DBM Fasciatherapy, Physiotherapy, Manual Therapy, Fascia
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: FasciaFranceUniversity, hospital or other
Collaborators: University Fernando Pessoa
Study start: 1 May 2021 (actual)
Primary completion: 6 Sep 2023 (actual)
Study completion: 6 Sep 2023 (actual)
First posted: 24 Mar 2021 (actual)
Results: Posted 24 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In France, fasciatherapy is not part of recommendations and is not recognized by the Conseil National de l'Ordre des Masseurs-Kinésithérapeutes.

The study will take place in France and the treatment structures will be the practitioners' practice.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Physiotherapy	Active comparator	Procedure: PhysiotherapyConventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines
Physiotherapy and Fasciatherapy	Experimental	Procedure: Fasciatherapy, Procedure: PhysiotherapyConventional physiotherapy, in line with french "Haute Autorité de Santé" guidelines, associated with Fasciatherapy Danis Bois Method
Fasciatherapy	Experimental	Procedure: FasciatherapyFasciatherapy Danis Bois Method

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FasciatherapyAlso: DBM Fasciatherapy, Danis Bois Method FasciatherapyFasciatherapy, with manual therapy and/or gestual therapy.	Procedure or surgery	Fasciatherapy, Physiotherapy and Fasciatherapy
PhysiotherapyAlso: Physical TherapyConventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.	Procedure or surgery	Physiotherapy, Physiotherapy and Fasciatherapy

Primary outcome

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

29 secondary outcomes

Change in Trait of Anxiety
Time frame: Before the 1st session
Evaluation of State of Anxiety
Time frame: Before the 1st session (start of the study for the patient)
Evaluation of State of Anxiety
Time frame: After the 1st session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety
Time frame: Before the 2nd session (within a total timeframe of 3 months)
Evaluation of State of Anxiety
Time frame: After the 2nd session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety
Time frame: Before the 3rd session (within a total timeframe of 3 months)
Evaluation of State of Anxiety
Time frame: After the 3rd session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety
Time frame: Before the 4th session (within a total timeframe of 3 months)
Evaluation of State of Anxiety
Time frame: After the 4th session (30 to 45 minutes after the previous measure)
Evaluation of State of Anxiety
Time frame: Before the 5th session (within a total timeframe of 3 months)
Evaluation of State of Anxiety
Time frame: After the 5th session (30 to 45 minutes after the previous measure)
Analgesic Consumption
Time frame: 1st session (start of the study for the patient)
Analgesic Consumption
Time frame: 2nd session (within a total timeframe of 3 months)
Analgesic Consumption
Time frame: 3rd session (within a total timeframe of 3 months)
Analgesic Consumption
Time frame: 4th session (within a total timeframe of 3 months)
Analgesic Consumption
Time frame: 5th session (within a total timeframe of 3 months)
Change in Trait of Anxiety
Time frame: After the last (5st) session, in a timeframe of 3 months
Change in the Quality of Life - Physical Score
Time frame: Before the 1st session
Change in the Quality of Life - Physical Score
Time frame: After the 5st session
Change in the Quality of Life - Mental Score
Time frame: Before the 1st session
Change in the Quality of Life - Mental Score
Time frame: After the 5st session
Change in Functional Abilities - Daily Activities
Time frame: Before the 1st session
Change in Functional Abilities - Daily Activities
Time frame: After the 5st session
Change in Functional Abilities - Professional and Leisure Activities
Time frame: Before the 1st session
Change in Functional Abilities - Professional and Leisure Activities
Time frame: After the 5st session
Change in Functional Abilities - Anxiety and Depression
Time frame: Before the 1st session
Change in Functional Abilities - Anxiety and Depression
Time frame: After the 5st session
Change in Functional Abilities - Sociability
Time frame: Before the 1st session
Change in Functional Abilities - Sociability
Time frame: After the 5st session

Results and safety

Results posted to the registry on 24 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Comparator: Physiotherapy	63	63
Experimental: Physiotherapy and Fasciatherapy	62	62
Experimental: Fasciatherapy	63	63

Primary outcome: Pain Intensity

Time frame: Before the 1st session (start of the study for the patient). Mean (Standard Deviation). Unit: score on a scale

Measure	Active Comparator: Physiotherapy n = 63	Experimental: Physiotherapy and Fasciatherapy n = 62	Experimental: Fasciatherapy n = 63
Value	4.2 (2.4)	4.1 (2.2)	4.0 (2.1)

Primary outcome: Pain Intensity

Time frame: After the 1st session (30 to 45 minutes after the previous measure). Mean (Standard Deviation). Unit: score on a scale

Measure	Active Comparator: Physiotherapy n = 63	Experimental: Physiotherapy and Fasciatherapy n = 62	Experimental: Fasciatherapy n = 63
Value	2.9 (2.3)	2.9 (2.2)	2.6 (2.1)

Primary outcome: Pain Intensity

Time frame: Before the 2nd session (within a total timeframe of 3 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Active Comparator: Physiotherapy n = 63	Experimental: Physiotherapy and Fasciatherapy n = 62	Experimental: Fasciatherapy n = 63
Value	3.7 (2.2)	3.7 (2.6)	3.1 (2.4)

Primary outcome: Pain Intensity

Time frame: After the 2nd session (30 to 45 minutes after the previous measure). Mean (Standard Deviation). Unit: score on a scale

Measure	Active Comparator: Physiotherapy n = 63	Experimental: Physiotherapy and Fasciatherapy n = 62	Experimental: Fasciatherapy n = 63
Value	2.3 (1.8)	2.3 (2.1)	2.2 (2.0)

29 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator: Physiotherapy	0 of 63 (0%)	0 of 63 (0%)	0 of 63
Experimental: Physiotherapy and Fasciatherapy	0 of 62 (0%)	0 of 62 (0%)	0 of 62
Experimental: Fasciatherapy	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24108286Bruyere 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.
Background: PubMed 9540121Marty 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.
Background: PubMed 9817119Leplege 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.
Background: PubMed 2524890Lawlis 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.
BackgroundWare 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;
Background: PubMed 6602967Carlsson 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.
BackgroundBoureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.
Background: PubMed 28584816Wilke 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.
BackgroundCourraud 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.
French Haute Autorité de Santé guidelines for the treatment of non-specific Low Back PainLink provided by the sponsor.
Individual participant dataSharing planned: No. No IPD sharing

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christian Courraud, PhD, PT study director

Centre d'Etude et de Recherche Appliquée en Psychopédagogie perceptive - University Fernando Pessoa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fasciatherapy and Physiotherapy in people with Low Back Pain, run by FasciaFrance at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Before the 1st session (start of the study for the patient)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04812678, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.