EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial

NCT00709566 | Unknown Phase 3

• 1 other identifier: RoyalCSI
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

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.

Conditions

Hip Osteoarthritis

Keywords

Hip; osteoarthritis; exercise; manual therapy

Outcome Measures

Primary Outcomes (1)

• WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale

  0, 9, 18 weeks

Secondary Outcomes (11)

• 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

Study Arms (3)

Control

NO INTERVENTION

Waiting List control.

Exercise therapy

ACTIVE COMPARATOR

Behavioral: Exercise therapy

Combined therapy

EXPERIMENTAL

Combined Exercise therapy and Manual Therapy

Behavioral: Combined exercise and manual therapy

Interventions

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.

Exercise therapy

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

Combined therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (4)

Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital

Dublin, Dublin, Dublin 24, Ireland

Location

St Vincent's University Hospital

Dublin, Dublin, Dublin 4, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Dublin, Dublin 7, Ireland

Location

Beaumont Hospital

Dublin, Dublin, Dublin 9, Ireland

Location

Related 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.

  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.

  PMID: 19152689 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis; Motor Activity

Interventions

Exercise Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Complementary Therapies

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

IE (4)