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
Duration of Study in the UK
3 years, 8 months, 1 days
Research summary
We plan to conduct two pragmatic randomised controlled trials of adjunctive physiotherapy for patients with axial spondyloarthritis (axSpA), seeking to improve outcomes in that patient group by comparing different physiotherapy treatments in subsequent trials.
Trial A will compare routine care vs routine care plus manual mobilisation physiotherapy.
Trial B will compare routine care vs routine care plus strength and condition physiotherapy.In order to recruit patients and obtain outcomes for Trials A and B we will first recruit up to 500 axSpA patients receiving care at the Royal National Hospital for Rheumatic Diseases (RNHRD) into a cohort and observe their outcomes over the duration of the study,
using a Trials within Cohort (TwiCs) design. Patients will be asked to consent to (i) provide routine observational data on their wellbeing, (ii) be approached to take part in future trials of interventions which aim to improve outcomes for patients with axSpA, and (iii) not be approached unless they are offered a physiotherapy trial intervention. Post randomisation, only those randomly selected to an intervention group will be informed about the experimental intervention and asked for their ‘clinical’ consent to receive these, with the majority of cohort participants functioning as ‘control group’ for observation only.The TwiCs design is currently being used in over 70 studies worldwide, including many in the UK and Canada. This method of providing information and seeking consent replicates the informed consent procedures in routine care.
Our study is aimed to last three years with the individual trials ranging between three to six months duration of therapy intervention in addition to routine standard of care at the RNHRD. Each trial aims to have 20-30 participants in the intervention group and an equal number in the control group.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/LO/0199
Date of REC Opinion
10 Mar 2020
REC opinion
Unfavourable Opinion