Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)

Axial Spondyloarthritis (axSPA) Clinical Trial

— YOKISPA  

Official title:

Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06083090
• Other study ID #: APHP210998
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Petra PAREJO MARGALLO
• Phone: +33 1 49 81 80 51
• Email: petri.parejo-margallo[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. The recommendations emphasize that the non-pharmacological treatment of axSPA should include regular physical exercise, that individual and group physical therapy sessions should be considered as well as self-exercises. Several randomized controlled trials have shown that physical therapy with various modalities has positive effects on pain and AS function. Physical therapy therefore also seems to play an important role in the management of patients. It prevents stiffness and improves functional capacity and quality of life. Physical therapy should be initiated as soon as axSPA is diagnosed and regular exercise should form the basis of management. The review by Zochling et al. as well as a systematic review showed that exercises have positive effects on BASFI, BASDAI functions, pain and mobility. A Cochrane review on the role of physiotherapy interventions in SPA also concluded that physical therapy was beneficial. Physical activity, self-exercises and physiotherapy are part of the 2022 recommendations of the French Society of Rheumatology. Beneficial effects on disease activity were observed in axSPA, with good tolerance for intense exercise. Recently an Indian team evaluated the effectiveness of online yogatherapy with 60 min structured modules on patients with axSPA for 3 months, with a significant improvement in the BASDAI score.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: April 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Axial Spondyloarthritis (axSPA)
• Spondylarthritis
• Spondylitis

Intervention

Procedure:
• Yogatherapy
The experimental arm will benefit from support by a physiotherapist trained in yoga, in a group for ten weeks with two weekly sessions of approximately 1 hour each. A new yoga program adapted for the axSPA will be implemented.
• Physiotherapy
The comparator arm will benefit from support by a physiotherapist, in groups for ten weeks at the rate of two weekly sessions of approximately 1 hour each. An already existing program adapted for the axSPA will be implemented.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the axSPA global activity score (fatigue, pain, stiffness)	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).	Between the 2 month visit and the 5 month visit.
Secondary	Evolution of the axSPA global activity score (fatigue, pain, stiffness)	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).	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Functional impact	Change in self-assessment of functional capacity during daily tasks via the BASFI score (Bath Ankylosing Spondylitis disease Functional Index) (10 items, max score = 10, the higher the score the more disabling the disease).	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Health-related quality of life	Change in the patient's self-assessment via the generic SF-36 scale (Short Form-36 scale) (36 items, max score = 100, the higher the score the better the perception of quality of life).	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Anxiety and depression	Change in the patient's self-assessment via the HAD scale (Hospital Anxiety and Depression scale) (14 items, max anxiety score = 21, max depression score = 21, the higher the score the more anxiety and depressive disorders are marked).	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Respiratory capacity	Measurement of chest expansion.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Spinal and axial mobility (maximum active amplitudes - sagittal plane)	Change in measurement of maximum active amplitudes in orthostatism of the thoraco-lumbar spine in the sagittal (flexion/extension) plane.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Spinal and axial mobility (degrees of kyphosis and lordosis)	Change in measurement of the degrees of kyphosis and lordosis while standing.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Spinal and axial mobility (maximum active amplitudes - frontal plane)	Change in measurement of maximum active amplitudes in orthostatism of the thoraco-lumbar spine in the frontal (lateral inclinations) plane.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Spinal and axial mobility (podobarometric treadmill)	Change in measurement of the spatiotemporal analysis of gait on a podobarometric treadmill.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Axial mobility	Change in BASMI (Bath Ankylosing Spondylitis Metrology Index) score (5 items, max score = 10, the higher the score the more restricted the axial mobility).	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Follow-up of the therapeutic strategy	Change in therapeutic strategy.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Drug consumption monitoring	Change in drug consumption.	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Sleep quality	Change in QESL score (Leeds Sleep Assessment Questionnaire) (10 visual analog scales, minimum = -50, maximum = 50, the higher the score the better the sleep).	Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Secondary	Adherence to the practice of yogatherapy of patients randomized in this group	Degree of adherence to the practice of yogatherapy collected through responses to a short self-questionnaire.	After physical rehabilitation : at 5 month and 11 month visits.