EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial (EMPART)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Behavioral: Exercise therapy; Behavioral: Combined exercise and manual therapy

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, Dublin 7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, DUBLIN 4
    • St Vincent's University Hospital
  • Dublin, Ireland, Dublin 9
    • Beaumont Hospital
  • Dublin, Ireland, Dublin 24
    • Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Waiting List control.
Active Comparator: Exercise therapy	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.
Experimental: Combined therapy; Combined Exercise therapy and Manual Therapy	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale	0, 9, 18 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: July 1, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (Estimate): July 3, 2008

Study Record Updates

• Last Update Posted (Estimate): July 23, 2010
• Last Update Submitted That Met QC Criteria: July 22, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: osteoarthritis; exercise; manual therapy; Hip
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: RoyalCSI