Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 7
- Primary Endpoint
- Evolution of the axSPA global activity score (fatigue, pain, stiffness)
Study Overview
Brief Summary
A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on the physical and psychological level.
Yogatherapy is a non-drug "body-mind" approach that would be likely to improve the physical symptoms (pain, stiffness, in particular spinal and pelvic), internal organs (colitis) and psychological symptoms as well as the perception of fatigue of people with axSPA. A 2021 study showed the feasibility and acceptability of regular yogatherapy practice in patients with axSPA.
It is therefore necessary to conduct randomized controlled studies to assess the effectiveness of this management strategy.
Detailed Description
The term axial spondyloarthritis (axSPA) encompasses various inflammatory diseases of the spine, including ankylosing spondyloarthritis (AS) and non-radiographic axial spondyloarthritis (nr-axSPA).
axSPA is a chronic inflammatory joint disease affecting the axial skeleton. It is the second cause of chronic inflammatory rheumatism and affects 0.5 to 2% of the general population. It generally affects young adults, with a male predominance (2 men for 1 woman).
axSPA can lead to physical consequences (fatigue, pain, stiffness, with in particular serious damage to the spine causing functional impairment, etc.) and psychological consequences (anxiety, depression). It is responsible for a disability and a mediocre quality of life with, moreover, a significant socio-economic impact. In France, it is one of the long-term illnesses and may require heavy treatment.
The medicinal therapeutic side, taken care of by rheumatologists specializing in this pathology, has evolved a lot (from non-steroidal anti-inflammatory drugs [NSAIDs] to anti-tumor necrosis factor [anti-TNF] and anti-interleukin 17 [anti-IL 17]), allowing notable improvements. It is now a question of also developing the non-drug therapeutic side, to contribute to improving the quality of life, thus meeting the demand of patients with chronic diseases.
Information and therapeutic education occupy an important place, with results in favor of an improvement in the management of these diseases.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The evaluators of the secondary endpoints relating to measurements of respiratory and biomechanical parameters will be blinded to the patient randomization group.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •French-speaking patient aged 18 and over
- •Patient with axial spondyloarthritis (axSPA) according to Assessment of SpondyloArthritis International Society, diagnosed by a rheumatologist
- •"Moderately active" to "active" form of axSPA (basic BASDAI > 3)
- •Stable disease: No recent or foreseeable introduction in the next 6 months of drug treatments for axSPA (excluding analgesics)
- •Absence of disabling stress urinary incontinence
- •Geographical or organizational possibility of undergoing the study
- •Patient informed and having signed the informed consent form for participation in the research
Exclusion Criteria
- •Pregnancy or breastfeeding
- •Recent childbirth (within the last six months)
- •Patient already practicing yoga or having practiced it in the last six months
- •Abdominal or spinal surgery in the last six months
- •Motor neurological deficit
- •Sphincter deficit
- •Any other somatic pathology preventing the practice of physiotherapy or yogatherapy according to the opinion of the evaluating clinician
- •Depressive syndrome requiring specific treatment
- •Non-affiliation to a social security scheme (beneficiary or beneficiary) or to another social protection scheme
- •Patient deprived of liberty by judicial or administrative decision or under legal protection (guardianship, safeguard of justice)
- •Currently participating in or in a period of exclusion from: another interventional research involving human participants, a clinical trial on a medical product for human, a clinical investigation on a medical device. Participation in non-interventional research is authorized.
Arms & Interventions
Yogatherapy
Randomization of 36 patients in the yogatherapy group.
Intervention: Yogatherapy (Procedure)
Physiotherapy
Randomization of 36 patients in the physiotherapy group.
Intervention: Physiotherapy (Procedure)
Outcomes
Primary Outcomes
Evolution of the axSPA global activity score (fatigue, pain, stiffness)
Time Frame: Between the 2 month visit and the 5 month visit.
Change in the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score, via a self-administered questionnaire that assesses the "activity" of the disease (6 items, max score = 100, the higher the score the more disabling the disease).
Secondary Outcomes
- Anxiety and depression(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Evolution of the axSPA global activity score (fatigue, pain, stiffness)(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Spinal and axial mobility (degrees of kyphosis and lordosis)(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Spinal and axial mobility (podobarometric treadmill)(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Functional impact(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Respiratory capacity(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Follow-up of the therapeutic strategy(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Spinal and axial mobility (maximum active amplitudes - sagittal plane)(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Health-related quality of life(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Sleep quality(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Spinal and axial mobility (maximum active amplitudes - frontal plane)(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Axial mobility(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Drug consumption monitoring(Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.)
- Adherence to the practice of yogatherapy of patients randomized in this group(After physical rehabilitation : at 5 month and 11 month visits.)