Clinical trial NCT00709566: EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial
Official title: The Effectiveness of Exercise Therapy and Manual Therapy in Hip Osteoarthritis - A Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hip Osteoarthritis
Keywords: Hip
osteoarthritis
exercise
manual therapy
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
timeFrame: 0, 9, 18 weeks
Secondary outcomes:
measure: Numerical Rating Scale for Pain
timeFrame: 0,9,18 weeks
measure: WOMAC total score, pain and stiffness subscales
timeFrame: 0,9,18 weeks
measure: Global Assessment of Change- 7 Point Likert Scale
timeFrame: 9,18 weeks
measure: Hip Range of motion using goniometry
timeFrame: 0,9,18 weeks
measure: Short Form-36v2 (Quality of Life)
timeFrame: 0,9,18 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0,9,18 weeks
measure: Physiotherapy Out-Patient Survey for Patient Satisfaction
timeFrame: 18 weeks
measure: Medication Usage (pain diary and Medication Quantification Scale)
timeFrame: 0,9,18 weeks
measure: International Physical Activity Questionnaire (Short version)
timeFrame: 0,9,18 weeks
measure: Repeated sit to stand test
timeFrame: 0,9,18 weeks
measure: 50 foot walk test
timeFrame: 0,9,18 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Royal College of Surgeons in Ireland
name: Geraldine McCarthy, MD, FRCPI
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin, Ireland
name: Tara Cusack, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Surgeons in Ireland
name: Helen French, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.