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Physiotherapy of Axial Spondyloarthritis

NCT04679649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-05-16

No results posted yet for this study

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.

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.

Conditions

  • Axial Spondyloarthritis

Interventions

OTHER

Manual spinal mobilisation physiotherapy

Manual spinal mobilisation is a physiotherapy technique to improve spinal mobility by gently applying pressure manually on the each segmental vertebrae by hands-on treatment of a physiotherapist.

Sponsors & Collaborators

  • Royal United Hospitals Bath NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Jane Carter · Royal United Hospitals Bath NHS FT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-06-20
Completion
2022-07-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679649 on ClinicalTrials.gov