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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Waiting List control. | |
| Exercise therapy | Active Comparator |
| |
| Combined therapy | Experimental | Combined Exercise therapy and Manual Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise therapy | Behavioral | Participants will attend an exercise based programme once a week for 8 weeks. This will be supplemented by a home based exercise programme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale | 0, 9, 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale for Pain | 0,9,18 weeks | |
| WOMAC total score, pain and stiffness subscales | 0,9,18 weeks | |
| Global Assessment of Change- 7 Point Likert Scale |
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Inclusion Criteria:
Clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) (Altman et al, 1991):
Age 40-80 years except in 2 above (age >50 years).
Radiological evidence of osteoarthritis (2 of the following 3 criteria):
Referred for physiotherapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geraldine McCarthy, MD, FRCPI | Royal College of Surgeons in Ireland | Principal Investigator |
| Tara Cusack, PhD | University College Dublin, Ireland | Principal Investigator |
| Helen French, MSc | Royal College of Surgeons in Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital | Dublin | Dublin | Dublin 24 | Ireland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | French HP (2007). Physiotherapy management of osteoarthritis of the hip: a survey of current practice in acute hospitals and private practice in the Republic of Ireland, Physiotherapy, 93 (4), 253-260. | ||
| 19152689 | Background | French HP, Cusack T, Brennan A, White B, Gilsenan C, Fitzpatrick M, O'Connell P, Kane D, Fitzgerald O, McCarthy GM. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial. BMC Musculoskelet Disord. 2009 Jan 19;10:9. doi: 10.1186/1471-2474-10-9. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Combined exercise and manual therapy | Behavioral | 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 |
|
| 9,18 weeks |
| Hip Range of motion using goniometry | 0,9,18 weeks |
| Short Form-36v2 (Quality of Life) | 0,9,18 weeks |
| Hospital Anxiety and Depression Scale (HADS) | 0,9,18 weeks |
| Physiotherapy Out-Patient Survey for Patient Satisfaction | 18 weeks |
| Medication Usage (pain diary and Medication Quantification Scale) | 0,9,18 weeks |
| International Physical Activity Questionnaire (Short version) | 0,9,18 weeks |
| Repeated sit to stand test | 0,9,18 weeks |
| 50 foot walk test | 0,9,18 weeks |
| St Vincent's University Hospital |
| Dublin |
| Dublin |
| Dublin 4 |
| Ireland |
| Mater Misericordiae University Hospital | Dublin | Dublin | Dublin 7 | Ireland |
| Beaumont Hospital | Dublin | Dublin | Dublin 9 | Ireland |
| D001519 |
| Behavior |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000529 | Complementary Therapies |