Physiotherapy of Axial Spondyloarthritis

NCT04679649 | Completed

• 1 other identifier: PaxSpA V5 28072020
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

physiotherapy; manual mobilisation; axial spondyloarthritis

Outcome Measures

Primary Outcomes (2)

• Change of Spinal Mobility

  Spinal mobility will be measured using inertial measurement unit sensors; Electro muscle stimulation (EMS) for muscle activity

  baseline, 6 months, and follow-up at 12 months

• Change of Spinal Mobility

  Spinal mobility will be measured using the Bath Ankylosing Spondylitis Metrology Index (BASMI), scored on the mean of 5 items out of 0-10 (minimum value 0 maximum value 10), '0' being the best outcome and 10 being the worst outcome.

  baseline, 3 months & 6 months, and follow-up at 12 months

Secondary Outcomes (5)

• Change of Disease Activity

  baseline, 3 month, 6 month, 12 month

• Change of Functional limitation

  baseline, 3 month, 6 month, 12 month

• Change of Quality of Sleep (PROM)

  baseline, 3 month, 6 month, 12 month

• Change of Quality of Life (PROM)

  baseline, 3 month, 6 month, 12 month

• Change of Work Productivity (PROM)

  baseline, 3 month, 6 month, 12 month

Study Arms (2)

Trial A - Intervention Group (manual mobilisation)

EXPERIMENTAL

Participants will continue to receive routine care and 13 sessions of manual spinal mobilisation will be administered over a 6 months period to compare routine care vs routine care plus manual spine mobilisation physiotherapy.

Other: Manual spinal mobilisation physiotherapy

Trial A - Control Group (routine care)

NO INTERVENTION

Participants in control group will continue to receive routine care, and routine care measurements for axial spondyloarthritis will be taken at baseline, 3 months and 6 months plus follow up.

Interventions

Manual spinal mobilisation physiotherapy OTHER

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.

Also known as: "Maitland's" mobilisations

Trial A - Intervention Group (manual mobilisation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \> 18 years of age from the RUH Bath National Health Service (NHS) Foundation Trust Rheumatology service based at RNHRD who fulfil the modified New York Criteria or the Assessment of SpondyloArthritis international Society (ASAS) axial spondyloarthritis criteria giving written consent for participation.

You may not qualify if:

• Mechanical spinal disease causing red flag symptoms such as cauda equina syndrome
• Age \>70
• Pregnancy or breastfeeding
• Any malignancy
• Moderate coexistent other inflammatory conditions (such as rheumatoid arthritis, vasculitis or connective tissue disease, in order to minimise the effect particularly of inflammation). However clinical judgement might be used to judge the severity in some patients as to whether they are safe to be included in a trial.
• Any bridging syndesmophytes in the spine, to avoid the risk of causing vertebral fractures or instability

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead

Study Sites (2)

Sports Physiotherapy Calne

Calne, UK, SN11 9PR, United Kingdom

Location

Royal National Hospital for Rheumatic Diseases (RNHRD)

Bath, Wiltshire, BA1 3NG, United Kingdom

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Jane Carter

  Royal United Hospitals Bath NHS FT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Batch randomisation - computer generated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomised controlled clinical trial (RCT) with secondary element of observational cohort trial in line with the "Trials within Cohort design" (TwiCs). Trial A is Manual mobilisation of the spine.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 22, 2020
• Study Start: October 6, 2021
• Primary Completion: June 20, 2022
• Study Completion: July 30, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Study Protocol and Consent form become available once recruitment has started. Clinical Study report becomes available on study conclusion.
• Access Criteria: request access through Dr Raj Sengupta

Locations

GB (2)