Physiotherapy of axial Spondyloarthritis - Bath PaxSpA
Research type
Research Study
Full title
Physiotherapy in Axial Spondyloarthritis (PaxSpA) - Informing clinical practice by identifying optimal non-pharmacological therapy concepts for patients with axial spondyloarthritis.
IRAS ID
272244
Contact name
Romy Schwäbe
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Duration of Study in the UK
3 years, 8 months, 1 days
Research summary
This is a protocol for a study which sets up an ongoing cohort of patients with axial spondyloarthritis (axSpA) AND also a study for the first two (of possibly many) randomised controlled trials (RCTs) of non-pharmacological interventions that may identify therapies that will help improve outcomes for patients with axSpA. We will use a pragmatic single-centre cohort multiple randomised controlled trial (cmRCT) design. This method, also referred to as Trials within Cohort, uses an existing cohort, where patients consent to function as controls, but also to identify eligible trial participants, a proportion of whom will then be randomly selected to be offered the trial investigations. Several trials can be conducted drawing eligible samples from the same cohort.
We aim to recruit 500 axSpA patients into the cohort following identification from current patients receiving care at RNHRD and the existing Bath Spondyloarthritis database (ethics approval for Bath Spondyloarthritis Biobank (13/SW/0096) at South West-Central Bristol REC).
Most of the cohort will be functioning as control group with eligible participants randomly invited to take part to receive the trial interventions. Each trial aims to have 20-30 participants in the intervention group.Aims:
(1) To identify optimal non-pharmacological therapy approaches for different stages of axSpA
(2) To assess effectiveness of non-pharmacological treatments on disease activity and other outcome measures i.e. therapeutic response to spinal mobility & functional ability.
(3) to inform clinical practice for axSpA treatment and non-pharmacological management
Objectives:
(1) We will compare existing standard of care therapy concepts at the RNHRD to other concepts, by conducting cohort multiple randomised control trials (cmRCT) for different physiotherapy interventions, that would allow identification of optimal treatment concepts.
(2) We will identify optimal doses of treatments for different stages in axSpA by exploring various intensities/ numbers of treatment sessions of the intervention.REC name
North of Scotland Research Ethics Committee 2
REC reference
20/NS/0002
Date of REC Opinion
13 Jan 2020
REC opinion
Unfavourable Opinion