Hip OsteoarthritisPhase 3EMPARTNCT00709566
EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial
A Phase 3 study testing Exercise therapy and Combined exercise and manual therapy in people with Hip Osteoarthritis, run by Royal College of Surgeons, Ireland at 4 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Exercise therapy and Combined exercise and manual therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesIreland
- Study dates
- Apr 2008to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- joint space narrowing
- ESR<20mm/hr (American College of Rheumatology Criteria for the Classification and Reporting of Osteoarthritis of the Hip)
- Referred for physiotherapy
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Ireland4 sites
Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital
Dublin, Dublin, Dublin 24
St Vincent's University Hospital
Dublin, Dublin, Dublin 4
Mater Misericordiae University Hospital
Dublin, Dublin, Dublin 7
Beaumont Hospital
Dublin, Dublin, Dublin 9
About this study
Official title: 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.
Read the 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
- Exercise therapy (comprising strengthening, range of motion and aerobic exercise)
- Combined Exercise therapy and Manual Therapy
- 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Exercise therapy, Combined exercise and manual therapy
- Keywords
- Hip, osteoarthritis, exercise, manual therapy
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyBehavioural
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 therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Waiting List control. |
| Exercise therapy | Active comparator | Not described Receives: Behavioral: Exercise therapy |
| Combined therapy | Experimental | Combined Exercise therapy and Manual Therapy Receives: Behavioral: Combined exercise and manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
Measured: 0, 9, 18 weeks
Secondary outcomes (11)
Numerical Rating Scale for Pain
Measured: 0,9,18 weeks
WOMAC total score, pain and stiffness subscales
Measured: 0,9,18 weeks
Global Assessment of Change- 7 Point Likert Scale
Measured: 9,18 weeks
Hip Range of motion using goniometry
Measured: 0,9,18 weeks
Short Form-36v2 (Quality of Life)
Measured: 0,9,18 weeks
Hospital Anxiety and Depression Scale (HADS)
Measured: 0,9,18 weeks
Physiotherapy Out-Patient Survey for Patient Satisfaction
Measured: 18 weeks
Medication Usage (pain diary and Medication Quantification Scale)
Measured: 0,9,18 weeks
International Physical Activity Questionnaire (Short version)
Measured: 0,9,18 weeks
Repeated sit to stand test
Measured: 0,9,18 weeks
50 foot walk test
Measured: 0,9,18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Investigators
- Geraldine McCarthy, MD, FRCPI, Principal investigator, Royal College of Surgeons in IrelandTara Cusack, PhD, Principal investigator, University College Dublin, IrelandHelen French, MSc, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709566
- Sponsor's protocol ID
- RoyalCSI
- Acronym
- EMPART
- Status last verified
- Jul 2010
- First submitted
- 1 Jul 2008
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19152689
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercise Therapy and Manual Therapy in Hip Osteoarthritis - A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00709566
- Acronym / sponsor ID
- EMPART / RoyalCSI
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip, osteoarthritis, exercise, manual therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Exercise therapy (comprising strengthening, range of motion and aerobic exercise)
- Combined Exercise therapy and Manual Therapy
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Waiting List control. |
| Exercise therapy | Active comparator | Behavioral: Exercise therapy |
| Combined therapy | Experimental | Behavioral: Combined exercise and manual therapyCombined Exercise therapy and Manual Therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) (Altman et al, 1991):
- Age 40-80 years except in 2 above (age >50 years).
- Radiological evidence of osteoarthritis (2 of the following 3 criteria):
- Referred for physiotherapy
Key exclusion criteria (10 listed)
- Previous hip arthroplasty, history of congenital/adolescent hip disease
- Clinical signs of lumbar spine disease
- Physiotherapy in previous 6 months
- Pregnancy
- Hip fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapyParticipants will attend an exercise based programme once a week for 8 weeks. This will be supplemented by a home based exercise programme. | Behavioural | Exercise therapy |
| Combined exercise and manual therapyPatients 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 | Behavioural | Combined therapy |
Primary outcome
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
Time frame: 0, 9, 18 weeks
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
- BackgroundFrench 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: PubMed 19152689French 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine McCarthy, MD, FRCPI principal investigator
Royal College of Surgeons in Ireland
Tara Cusack, PhD principal investigator
University College Dublin, Ireland
Helen French, MSc principal investigator
Royal College of Surgeons in Ireland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise therapy and Combined exercise and manual therapy in people with Hip Osteoarthritis, run by Royal College of Surgeons, Ireland at 4 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale (time frame: 0, 9, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.