EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial — EMPART  

Hip Osteoarthritis Clinical Trial

Official title: The Effectiveness of Exercise Therapy and Manual Therapy in Hip Osteoarthritis - A Multicentre Randomised Controlled Trial

Status Active, not recruiting

Clinical Trial Summary

Hip osteoarthritis is a major cause of disability and reduced quality of life. Physiotherapy, which encompasses a range of interventions such as exercise therapy, manual therapy, education and electrophysical agents, is a core component of management. To date, exercise therapy to date has the greatest evidence of effect . However, this evidence is limited as only a short-term benefit has been identified and improvements in pain and function decline over time. There is some limited evidence for a beneficial effect of manual therapy over exercise. However, clinically these interventions are used in combination, not in isolation. To date, no research has investigated the combined effect of exercise and manual therapy in hip OA.

A multi-centre randomised controlled trial that compares the clinical effectiveness of a combination of manual therapy and exercise to exercise therapy only will be conducted.

Clinical Trial Description

A multi-centre RCT that evaluates the clinical effectiveness of two physiotherapy interventions for patients with osteoarthritis of the hip will be conducted The methodology will follow CONSORT (Consolidation of Standards of Reporting Trials) guidelines. Ethical approval for the study has been obtained from the Research Ethics Committees of the participating hospitals (Beaumont, St Vincent's University, Mater Misercordiae University Hospitals, Adelaide Meath Hospital Dublin, incorporating National Children's Hospital). Patients will be assessed at baseline, 9 weeks, (end of treatment) and 18 weeks. The treating therapists will be blinded to outcome assessments. Subjects cannot be blinded due to the nature of the interventions.

All patients with a diagnosis of Hip OA referred for physiotherapy from rheumatologists, GPs and orthopaedic consultants will be considered for inclusion into the RCT. Four similarly matched physiotherapy departments will be used: Beaumont Hospital (BH), St Vincent's University Hospital (SVUH) Adelaide Meath Hospital Dublin, incorporating National Children's Hospital) and Mater Misericordiae University Hospital (MMH).

Consenting subjects will be randomly allocated to one of 3 groups

1. Exercise therapy (comprising strengthening, range of motion and aerobic exercise)

2. Combined Exercise therapy and Manual Therapy

3. Control group (Waiting List). These patients will remain on the waiting list for a 9 week period and will then be randomized to one of the two intervention groups. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

• NCT number: NCT00709566
• Study type: Interventional
• Source: Royal College of Surgeons, Ireland
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 2008
• Completion date: December 2010