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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Participants will attend an exercise based programme once a week for 8 weeks. This will be supplemented by a home based exercise programme.
Patients will attend physiotherapy once a week for 8 weeks, where they will receive a combination of exercise therapy and manual therapy. Exercise will be supplemented by a home based exercise programme
Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital
Dublin, Dublin, Ireland
St Vincent's University Hospital
Dublin, Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, Dublin, Ireland
Beaumont Hospital
Dublin, Dublin, Ireland
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
Time frame: 0, 9, 18 weeks
Numerical Rating Scale for Pain
Time frame: 0,9,18 weeks
WOMAC total score, pain and stiffness subscales
Time frame: 0,9,18 weeks
Global Assessment of Change- 7 Point Likert Scale
Time frame: 9,18 weeks
Hip Range of motion using goniometry
Time frame: 0,9,18 weeks
Short Form-36v2 (Quality of Life)
Time frame: 0,9,18 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0,9,18 weeks
Physiotherapy Out-Patient Survey for Patient Satisfaction
Time frame: 18 weeks
Medication Usage (pain diary and Medication Quantification Scale)
Time frame: 0,9,18 weeks
International Physical Activity Questionnaire (Short version)
Time frame: 0,9,18 weeks
Repeated sit to stand test
Time frame: 0,9,18 weeks
50 foot walk test
Time frame: 0,9,18 weeks
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