RecruitingNot ApplicableNCT06083090

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

72 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria11

  • 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.

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Interventions

PROCEDUREYogatherapy

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.

PROCEDUREPhysiotherapy

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(5)

Hôpital Avicenne

Bobigny, France

Hôpital Henri Mondor

Créteil, France

Hôpital Henri Mondor

Créteil, France

Hôpital Pitié Salpetrière

Paris, France

Hôpital Cochin

Paris, France

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NCT06083090