EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial

Hip Osteoarthritis Clinical Trial

— EMPART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00709566
• Other study ID #: RoyalCSI
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 1, 2008
• Last updated: July 22, 2010
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) (Altman et al, 1991):

• Subjective complaint of hip pain with either hip internal rotation < 15 degrees and hip flexion <115 degrees or >15 degrees hip internal rotation and pain on hip internal rotation

• morning stiffness less than or equal to 60 minutes, age > 50 years.

• Age 40-80 years except in 2 above (age >50 years).

• Radiological evidence of osteoarthritis (2 of the following 3 criteria):

• osteophytes

• joint space narrowing

• ESR<20mm/hr (American College of Rheumatology Criteria for the Classification and Reporting of Osteoarthritis of the Hip)

• Referred for physiotherapy

Exclusion Criteria:

• Previous hip arthroplasty, history of congenital/adolescent hip disease

• Clinical signs of lumbar spine disease

• Physiotherapy in previous 6 months

• Pregnancy

• Hip fracture

• Contraindications to exercise therapy

• Contraindications to manual therapy

• On waiting list for joint replacement within the next 18 weeks

• Rheumatic diseases e.g. Rheumatoid Arthritis, Ankylosing Spondylitis, etc

• Hip cortisone injection in previous 30 days

Study Design

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Behavioral:
• Exercise therapy
Participants will attend an exercise based programme once a week for 8 weeks. This will be supplemented by a home based exercise programme.
• Combined exercise and manual therapy
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

Locations

Country	Name	City	State
Ireland	Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St Vincent's University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale		0, 9, 18 weeks	No
Secondary	Numerical Rating Scale for Pain		0,9,18 weeks	No
Secondary	WOMAC total score, pain and stiffness subscales		0,9,18 weeks	No
Secondary	Global Assessment of Change- 7 Point Likert Scale		9,18 weeks	No
Secondary	Hip Range of motion using goniometry		0,9,18 weeks	No
Secondary	Short Form-36v2 (Quality of Life)		0,9,18 weeks	No
Secondary	Hospital Anxiety and Depression Scale (HADS)		0,9,18 weeks	No
Secondary	Physiotherapy Out-Patient Survey for Patient Satisfaction		18 weeks	No
Secondary	Medication Usage (pain diary and Medication Quantification Scale)		0,9,18 weeks	No
Secondary	International Physical Activity Questionnaire (Short version)		0,9,18 weeks	No
Secondary	Repeated sit to stand test		0,9,18 weeks	No
Secondary	50 foot walk test		0,9,18 weeks	No