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Trial registered on ANZCTR


Registration number
ACTRN12608000130369
Ethics application status
Approved
Date submitted
6/03/2008
Date registered
13/03/2008
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The MOA trial – Management of OsteoArthritis by exercise therapy and/or manual physiotherapy in addition to usual care
Scientific title
In adults with osteoarthritis of the hip or knee, does exercise therapy and/or manual physiotherapy in addition to usual care reduce pain or disability?
Secondary ID [1] 280351 0
the MOA Trial
Universal Trial Number (UTN)
Trial acronym
The MOA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis/Hip 2732 0
Osteoarthritis/Knee 2733 0
Condition category
Condition code
Musculoskeletal 2859 2859 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Exercise physiotherapy: Strengthening, stretching, endurance and neuromuscular control exercises; one-hour sessions; 7 session in first 9 weeks, then 2 'booster' sessions at 4 months.
2. Manual physiotherapy: Techniques involving therapist-applied forces to improve joint and soft tissue mobility; one-hour sessions; 7 session in first 9 weeks, then 2 'booster' sessions at 4 months.
3. Combination therapy: Both exercise therapy and manual therapy; one-hour sessions; 7 session in first 9 weeks, then 2 'booster' sessions at 4 months.
4. Usual care: No trial physiotherapy
Intervention code [1] 2474 0
Treatment: Other
Comparator / control treatment
Usual care: All participants (all 4 trial arms) will continue to receive the usual, normal routine care offered by their own General Practitioner (GP) and other health practitioners.
Control group
Active

Outcomes
Primary outcome [1] 3741 0
Western Ontario and McMaster Osteoarthritis Index (WOMAC) composite score
Timepoint [1] 3741 0
1 year
Secondary outcome [1] 6321 0
Timed up-and-go test (timed physical performance test: patient stands from a chair, walks 3 metres, returns and sits back down in chair.)
Timepoint [1] 6321 0
1 year
Secondary outcome [2] 6322 0
30 second sit-to-stand test
Timepoint [2] 6322 0
1 year
Secondary outcome [3] 6323 0
40m self-paced walk test
Timepoint [3] 6323 0
1 year
Secondary outcome [4] 6324 0
Outcome Measures in Rheumatoid Arthritis Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria
Timepoint [4] 6324 0
1 years
Secondary outcome [5] 6325 0
Undergone joint replacement surgery
Timepoint [5] 6325 0
2 year
Secondary outcome [6] 6579 0
Costs assessed by patient self-report questionnaire and healthcare records
Timepoint [6] 6579 0
2 years
Secondary outcome [7] 6580 0
SF-12v2 (Quality Metric, Inc.)
Timepoint [7] 6580 0
1 and 2 years
Secondary outcome [8] 6601 0
WOMAC physical function subscale
Timepoint [8] 6601 0
1 year
Secondary outcome [9] 6602 0
WOMAC pain subscale
Timepoint [9] 6602 0
1 year
Secondary outcome [10] 6603 0
Patient-rated assessment of global improvement (using the Global Rating of Change instrument)
Timepoint [10] 6603 0
1 year
Secondary outcome [11] 6604 0
Numeric Pain Rating Scale
Timepoint [11] 6604 0
1 year

Eligibility
Key inclusion criteria
Patients referred for an orthopaedic consultation for hip or knee osteoarthritis and consideration for joint replacement surgery and who meet clinical criteria for diagnosis of osteoarthritis of the hip or knee according to American College of Rheumatology criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous knee or hip joint surgery;
- any other surgical procedure of the lower limbs in the prior 6 months;
- initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within prior 30 days;
- rheumatoid arthritis of the hip or knee;
- physical impairments preventing safe participation in exercise, manual therapy, walking or stationary cycling, such as: uncontrolled hypertension or AHA risk-rating of A3B or higher; vision problems that affect mobility, neurogenic disorder, primary or debilitating back pain, advanced osteoporosis, body mass >155kg, unable to ambulate 10m without an assistive device;
- insufficient communication ability to comprehend or comply with assessment interventions;
- stated inability to complete the proposed course of intervention and follow-up.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation after elibility established. Randomised allocation by web-based computer program. The Clinical Research Administrator enters details into program. The program is programmed, hosted and logged by an independent unit. Participant informed by Clinical Research Administrator. Allocation is concealed from assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by condition (hip, knee) in blocks of randomly varying size, generated by statistician using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 739 0
New Zealand
State/province [1] 739 0
Otago

Funding & Sponsors
Funding source category [1] 2991 0
Government body
Name [1] 2991 0
Health Research Council of New Zealand
Address [1] 2991 0
Level 3
110 Stanley St
PO Box 5541
Wellesley St
Auckland 1141
Country [1] 2991 0
New Zealand
Funding source category [2] 2992 0
Government body
Name [2] 2992 0
New Zealand Lottery Health Grants Board
Address [2] 2992 0
Level 1
46 Waring Taylor St
PO Box 805
Wellington
Country [2] 2992 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Centre for Musculoskeletal Outcomes Research, Orthopaedic Surgical Sciences, Dunedin School of Medicine, PO Box 913, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 2699 0
Individual
Name [1] 2699 0
Dr J.Haxby Abbott
Address [1] 2699 0
Centre for Musculoskeletal Outcomes Research, Orthopaedic Surgical Sciences, Dunedin School of Medicine, PO Box 913, Dunedin
Country [1] 2699 0
New Zealand
Other collaborator category [1] 160 0
Individual
Name [1] 160 0
Professor G.David Baxter
Address [1] 160 0
School of Physiotherapy
University of Otago
Level 3
325 Great King St
PO Box 56
Dunedin
Country [1] 160 0
New Zealand
Other collaborator category [2] 161 0
Individual
Name [2] 161 0
Associate Professor M.Clare Robertson
Address [2] 161 0
Department of Medical & Surgical Science
University of Otago
Level 9
Dunedin Hospital
Great King St
PO Box 913
Dunedin
Country [2] 161 0
New Zealand
Other collaborator category [3] 162 0
Individual
Name [3] 162 0
Associate Professor Jean-Claude Theis
Address [3] 162 0
Department of Medical & Surgical Sciences
University of Otago
Level 9
Dunedin Hospital
Great King St
PO Box 913
Dunedin
Country [3] 162 0
New Zealand
Other collaborator category [4] 163 0
Individual
Name [4] 163 0
Professor A.John Campbell
Address [4] 163 0
Department of Medical & Surgical Sciences
University of Otago
Level 9
Dunedin Hospital
Great King St
PO Box 913
Dunedin
Country [4] 163 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4951 0
Lower South Regional Ethics Committee
Ethics committee address [1] 4951 0
Ministry of Health Building
229 Moray Place
PO Box 5849
Dunedin
Ethics committee country [1] 4951 0
New Zealand
Date submitted for ethics approval [1] 4951 0
29/10/2007
Approval date [1] 4951 0
22/11/2007
Ethics approval number [1] 4951 0
LRS/07/11/044

Summary
Brief summary
We will investigate: 1) whether exercise therapy will be more effective than no exercise therapy, whether manual therapy will be more effective than no manual therapy, and whether exercise therapy with manual therapy will have an additive or interaction effect over just one mode of therapy; 2) whether, overall, physiotherapy interventions in addition to usual medical care will be more effective than usual care alone for reducing pain and disability in patients with osteoarthritis of the hip and knee; 3) whether the proportion of participants undergoing joint replacement surgery is lower in the groups receiving trial physiotherapy interventions compared to the group receiving usual care alone; and 4) the incremental cost-effectiveness of providing physiotherapy interventions for patients with OA of the hip or knee.
Trial website
Trial related presentations / publications
1. Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis J-C, Campbell AJ, for the MOA Trial Team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis & Cartilage. 2013; 21:525-534
2. Pinto D, Robertson MC, Hansen P, Campbell AJ, Abbott JH. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee. 2: Economic evaluation alongside a randomized controlled trial. Osteoarthritis & Cartilage. 2013; 21:1504-1513
3. Abbott JH, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Theis J-C, for the MOA Trial Team. Exercise Therapy and/or Manual Therapy for Hip or Knee Osteoarthritis: 2-Year Follow-up of a Randomized Controlled Trial. Presented at the American College of Rheumatology 2014 ACR/AHPR Annual Meeting, Boston, MA, November 14-19, 2014. Arthritis & Rheumatology. 2014;10(Suppl.):S1266
4. Abbott JH, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis J-C, for the MOA Trial Team. Exercise therapy, manual therapy, or both, for management of osteoarthritis of the hip or knee: 2-year follow-up of a randomized clinical trial. Platform presentation at the Osteoarthritis Research Society International Conference OARSI 2014. April 23-27, Paris, France. Abstract published in Osteoarthritis & Cartilage, 2014; 22 Suppl.: S51
Public notes

Contacts
Principal investigator
Name 28311 0
A/Prof J. Haxby Abbott
Address 28311 0
Centre for Musculoskeletal Outcomes Research, Orthopaedic Surgical Sciences, Dunedin School of Medicine, PO Box 913, Dunedin
Country 28311 0
New Zealand
Phone 28311 0
+64 3 474-0999 x58615
Fax 28311 0
Email 28311 0
haxby.abbott@otago.ac.nz
Contact person for public queries
Name 11468 0
A/Prof Dr J.Haxby Abbott
Address 11468 0
Centre for Musculoskeletal Outcomes Research, Orthopaedic Surgical Sciences, Dunedin School of Medicine, PO Box 913, Dunedin
Country 11468 0
New Zealand
Phone 11468 0
+64 3 474-0999 x58615
Fax 11468 0
+64 3 474-7617
Email 11468 0
haxby.abbott@otago.ac.nz
Contact person for scientific queries
Name 2396 0
A/Prof Dr J.Haxby Abbott
Address 2396 0
Centre for Musculoskeletal Outcomes Research, Orthopaedic Surgical Sciences, Dunedin School of Medicine, PO Box 913, Dunedin
Country 2396 0
New Zealand
Phone 2396 0
+64 3 474-0999 x58615
Fax 2396 0
+64 3 474-7617
Email 2396 0
haxby.abbott@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary