NCT04679649: PaxSpA

Physiotherapy of Axial Spondyloarthritis

Completed NA Last updated 16 May 2024

What this trial tests

NA trial testing Manual spinal mobilisation physiotherapy in Axial Spondyloarthritis in 38 participants. Completed in 30 July 2022.

Timeline

6 October 2021

Primary endpoint
20 June 2022

30 July 2022

Quick facts

Lead sponsor	Royal United Hospitals Bath NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	6 October 2021
Primary completion	20 June 2022
Estimated completion	30 July 2022
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Manual spinal mobilisation physiotherapy

Conditions studied

• Axial Spondyloarthritis — all drugs for Axial Spondyloarthritis →

Sponsor

Royal United Hospitals Bath NHS Foundation Trust

Who can join

Adults 18 to 70, any sex, with Axial Spondyloarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

The investigators 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), the investigators 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 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. This 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.