Overview

This trial is active, not recruiting.

Condition hip osteoarthritis
Treatments exercise therapy, combined exercise and manual therapy
Phase phase 3
Sponsor Royal College of Surgeons, Ireland
Start date April 2008
End date September 2010
Trial size 150 participants
Trial identifier NCT00709566, RoyalCSI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(No Intervention)
Waiting List control.
(Active Comparator)
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 Exercise therapy and Manual Therapy
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

Primary Outcomes

Measure
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
time frame: 0, 9, 18 weeks

Secondary Outcomes

Measure
Numerical Rating Scale for Pain
time frame: 0,9,18 weeks
WOMAC total score, pain and stiffness subscales
time frame: 0,9,18 weeks
Global Assessment of Change- 7 Point Likert Scale
time frame: 9,18 weeks
Hip Range of motion using goniometry
time frame: 0,9,18 weeks
Short Form-36v2 (Quality of Life)
time frame: 0,9,18 weeks
Hospital Anxiety and Depression Scale (HADS)
time frame: 0,9,18 weeks
Physiotherapy Out-Patient Survey for Patient Satisfaction
time frame: 18 weeks
Medication Usage (pain diary and Medication Quantification Scale)
time frame: 0,9,18 weeks
International Physical Activity Questionnaire (Short version)
time frame: 0,9,18 weeks
Repeated sit to stand test
time frame: 0,9,18 weeks
50 foot walk test
time frame: 0,9,18 weeks

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title The Effectiveness of Exercise Therapy and Manual Therapy in Hip Osteoarthritis - A Multicentre Randomised Controlled Trial
Principal investigator Geraldine McCarthy, MD, FRCPI
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Royal College of Surgeons, Ireland.