Physiotherapy of axial Spondyloarthritis - Bath PaxSpA
Research type
Research Study
Full title
Physiotherapy in Axial Spondyloarthritis (PaxSpA) - Trials of physiotherapeutic treatments for patients with axial spondyloarthritis, to inform clinical practice by identifying optimal non-pharmacological therapies.
IRAS ID
272244
Contact name
Romy Schwäbe
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
This protocol is for a pragmatic randomised controlled clinical trial (RCT) with a manual spinal mobilisation (MSM) intervention for patients with axial spondyloarthritis (axSpA), embedded in a Trials within Cohort (TwiCs) design. This trial might appear as a standardised RCT but there is a secondary element – an observational cohort the trial is embedded in. Trial A is the first (of possibly several) embedded pragmatic RCTs involving physiotherapy interventions that may identify therapies that will help improve outcomes for patients with axSpA.
We are seeking to improve outcomes for these patients by comparing different physiotherapy interventions in subsequent trials with standard of care (SoC) physiotherapy.
Trial A will compare routine care vs routine care plus MSM physiotherapy attempting to answer the primary research question if MSM on patients with axSpA improves spinal mobility.In order to recruit patients and obtain outcomes for Trial A (n=70), we will first recruit up to 300 axSpA patients receiving care at the Royal National Hospital for Rheumatic Diseases (RNHRD) in Bath into a cohort and observe their standard of care outcomes. This will allow us to answer the cohort’s research question of "How does SoC physiotherapy in patients with axSpA reflect in data collected routinely on outcomes of the disease?"
Patients will be asked to consent to provide routine observational data on their wellbeing, be approached to take part in future trials of interventions which aim to improve outcomes for patients with axSpA, and not be approached unless they are offered the physiotherapy trial intervention. This highly pragmatic method of providing information and seeking consent replicates the informed consent procedures in routine care clinical settings.
Our study is aimed to last three years, with individual trials of 40-70 participants, ranging between three to six months duration of therapy intervention in addition to routine care.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/LO/0868
Date of REC Opinion
18 Aug 2020
REC opinion
Further Information Favourable Opinion