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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yogatherapy

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: YogatherapyExperimental treatment 1 intervention
Group B: PhysiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Between the 2 month visit and the 5 month visit.

Secondary outcomes

1

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).

Time frame
Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
2

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).

Time frame
Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
3

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).

Time frame
Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
4

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).

Time frame
Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.

Other outcomes

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