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Trial registered on ANZCTR


Registration number
ACTRN12612000460808
Ethics application status
Approved
Date submitted
17/04/2012
Date registered
24/04/2012
Date last updated
11/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing the effectiveness of physiotherapy for people with knee osteoarthritis
Scientific title
In people with knee osteoarthritis, does manual therapy in addition to exercise therapy reduce pain and disability, compared with exercise therapy alone, and do booster sessions enhance the effectiveness compared with no booster sessions.
Secondary ID [1] 280352 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis
MESH term: Osteoarthritis/Knee 286316 0
Condition category
Condition code
Musculoskeletal 286555 286555 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise therapy (40 minutes) - All participants do this
The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.

Manual therapy (40 minutes)
The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings.

Booster sessions (40 minutes)
Subjects in the standard (comparator) arm receive 12 treatment sessions in 9 weeks. Subjects in the booster (experimental) arm will receive 12 treatment sessions delivered with booster sessions (8 sessions in the first 9 weeks, 2 sessions at 5 months, 1 session at 8 months, and 1 session at 11 months).

All treatment sessions are supervised, delivered by physiotherapists to individual patients.

This study features a 2x2 factorial design: Factor 1: manual therapy vs no manual therapy Factor 2: booster vs no booster. All participants receive exercise therapy. By random allocation, participants may be assigned manual therapy and/or booster sessions in addition to exercise therapy.

NCT01314183 is the ClinicalTrials.gov ID for the US centres of this multi-centre trial. This registration is for the associated NZ-based study. The research protocol and treatment protocols are the same in the NZ study as in the US centres of this multi-centre trial.
Intervention code [1] 284716 0
Treatment: Other
Intervention code [2] 284722 0
Rehabilitation
Comparator / control treatment
Exercise therapy only (no Manual therapy)
No booster sessions
Control group
Active

Outcomes
Primary outcome [1] 286984 0
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC
Timepoint [1] 286984 0
Change from baseline at 9 weeks, 1 year and 2 years. Primary outcome at 1 year.
Secondary outcome [1] 297133 0
Cost/Utility Ratio.
Cost will be assessed using the Otago Osteoarthritis Costs and Consequences Questionnaire (Pinto et al 2011 BMC Med Res Methodol). Utility will be derived from the EQ-5D. We will calculate cost per quality adjusted life years gained (cost/QALY) and present these as incremental cost-effectiveness ratios (ICERs) cost-effectiveness acceptability curves (CEACs), from both a societal perspective (primary analysis) and health system perspective (secondary).
Timepoint [1] 297133 0
2 years
Secondary outcome [2] 297134 0
Change in Numeric Knee Pain Rating Scale
Timepoint [2] 297134 0
Baseline to 9 weeks, 1 and 2 years
Secondary outcome [3] 297135 0
Global Rating of Change
Timepoint [3] 297135 0
Baseline to 9 weeks, 1 year
Secondary outcome [4] 297136 0
Timed Up and Go Test.
Time in seconds to stand up from a chair, walk 3 meters, turn around, return to the chair and sit down.
Timepoint [4] 297136 0
Baseline to 9 weeks, 1 year
Secondary outcome [5] 297137 0
30 second time chair rise test
Timepoint [5] 297137 0
Baseline to 9 weeks, 1 year
Secondary outcome [6] 297138 0
40m Self-paced Walk Test
Timepoint [6] 297138 0
Baseline to 9 weeks, 1 year
Secondary outcome [7] 297139 0
Pain belief screening instrument
Timepoint [7] 297139 0
Baseline to 1 year
Secondary outcome [8] 297140 0
Beck Anxiety Index (BAI)
Timepoint [8] 297140 0
Baseline to 1 year
Secondary outcome [9] 297141 0
Center for Epidemiological Studies Depression Scale (CES-D)
Timepoint [9] 297141 0
Baseline to 1 year
Secondary outcome [10] 297142 0
EQ-5D
A standardised patient-reported outcome measure of preference states, from which quality-adjusted life years (QALYs) can be calculated.
Timepoint [10] 297142 0
Baseline to 1 year

Eligibility
Key inclusion criteria
40 years of age or older
Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the following 6 criteria:
age > 50 years,
morning stiffness of < 30 minutes,
crepitus on active movement,
tenderness of the bony margins of the joint,
bony enlargement of the joint noted on exam,
lack of palpable warmth of the synovium. Based on this criteria, a subject who is less than 50 years but has knee pain and 3 of the other 5 criteria would also be classified as having knee OA.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
do not meet the ACR clinical criteria for knee OA,
are scheduled for total knee arthroplasty (TKA) surgery,
have undergone TJA surgery on any lower extremity joint,
exhibit uncontrolled hypertension (i.e. individuals not currently taking medication for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg at rest),
have complaints of low back pain or other lower extremity joint pain that affects function at the time of recruitment,
have a history of neurological disorders that would affect lower extremity function (stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),
are women who are pregnant.

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 was concealed. The assessor who determines if a subject is eligible for inclusion in the trial is unaware, when this decision was made, to which group the subject will be allocated. Group allocation is administrated subsequent to inclusion and baseline assessment by a researcher (the holder of the allocation schedule) not involved in enrolment, baseline or follow-up assessment, at a location remote to the assessment and enrolment location. Assessors remain blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated sequence
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
2x2 factorial design:
Factor 1: manual therapy vs no manual therapy
Factor 2: booster vs no booster
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2011
Actual
21/04/2011
Date of last participant enrolment
Anticipated
Actual
19/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 4267 0
New Zealand
State/province [1] 4267 0

Funding & Sponsors
Funding source category [1] 285123 0
University
Name [1] 285123 0
University of Otago
Country [1] 285123 0
New Zealand
Funding source category [2] 285124 0
Government body
Name [2] 285124 0
Health Research Council of New Zealand
Country [2] 285124 0
New Zealand
Funding source category [3] 285126 0
Government body
Name [3] 285126 0
New Zealand Lottery Grants Board
Country [3] 285126 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 283989 0
Individual
Name [1] 283989 0
Dr J. Haxby Abbott
Address [1] 283989 0
Centre for Musculoskeletal Outcomes Research
Orthopaedic Surgical Sciences Department
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [1] 283989 0
New Zealand
Other collaborator category [1] 260751 0
Individual
Name [1] 260751 0
Professor Jean-Claude Theis
Address [1] 260751 0
Orthopaedic Surgical Sciences Department
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [1] 260751 0
New Zealand
Other collaborator category [2] 260752 0
Individual
Name [2] 260752 0
G. Kelley Fitzgerald
Address [2] 260752 0
School of Health and Rehabilitation Sciences
University of Pittsburgh
6035 Forbes Tower
Pittsburgh, PA 15260
Country [2] 260752 0
United States of America
Other collaborator category [3] 260753 0
Individual
Name [3] 260753 0
Julie M. Fritz
Address [3] 260753 0
University of Utah,
Division of Physical Therapy
520 Wakara Way
Salt Lake City UT 84108
Country [3] 260753 0
United States of America
Other collaborator category [4] 260754 0
Individual
Name [4] 260754 0
John D. Childs
Address [4] 260754 0
US Army-Baylor University
81st Medical Group, Keesler Air Force Base - Department of Physical Therapy (MSGS/SGCUY),
Biloxi, Mississippi 39534
Country [4] 260754 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287142 0
Lower South Regional Ethics Committee
Ethics committee address [1] 287142 0
Ministry of Health Building
229 Moray Place
PO Box 5849
Dunedin 9016
Ethics committee country [1] 287142 0
New Zealand
Date submitted for ethics approval [1] 287142 0
Approval date [1] 287142 0
17/12/2010
Ethics approval number [1] 287142 0
LSR/10/11/055

Summary
Brief summary
The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions (periodic face-to-face follow-up appointments that take place several weeks or months following discharge from the supervised therapy program designed to review the patient's current rehabilitation program, troubleshoot any problems with the program, and make recommendations for program progression or modification) in the delivery of exercise therapy, and supplementing exercise therapy with manual therapy techniques (manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching and range of motion). The investigators will do this in a randomized, multi-center, clinical trial. The investigators hypothesize that adding manual therapy techniques will be more clinically effective than exercise alone and that using booster sessions will maintain longer term clinical effects and be more cost-effective than not using booster sessions. This is the NZ study affiliated with the US multi-centre trial ID: NCT01314183: http://clinicaltrials.gov /ct2/show/NCT01314183
Trial website
http://cmor.otago.ac.nz/demo_trial.html
Trial related presentations / publications
Abbott JH, Chapple CM, Fitzgerald GK, Fritz JM, Childs J, Harcombe H, Stout K. The incremental effects of manual therapy or booster sessions in addition to exercise therapy for knee osteoarthritis: A randomized clinical trial. J Orthop Sports Phys Ther. 2015; 45(12):975-983

Abbott JH, Fitzgerald GK, Fritz JM, Childs J, Chapple CM, Harcombe H. Do manual therapy or booster sessions in addition to exercise therapy for knee osteoarthritis provide additional benefits? A randomized clinical trial. Abstract from the Osteoarthritis Research Society International Conference OARSI 2015, published in Osteoarthritis & Cartilage, 2015; 23 Suppl.: A385
Public notes

Contacts
Principal investigator
Name 34083 0
A/Prof J. Haxby Abbott
Address 34083 0
Centre for Musculoskeletal Outcomes Research Orthopaedic Surgical Sciences Department Dunedin School of Medicine University of Otago PO Box 913 Dunedin 9054
Country 34083 0
New Zealand
Phone 34083 0
+64 3 474-0999 ext.58615
Fax 34083 0
Email 34083 0
[email protected]
Contact person for public queries
Name 17330 0
Dr J. Haxby Abbott
Address 17330 0
Centre for Musculoskeletal Outcomes Research
Orthopaedic Surgical Sciences Department
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country 17330 0
New Zealand
Phone 17330 0
+64 3 474-0999 ext.58615
Fax 17330 0
+64 3 474-7617
Email 17330 0
[email protected]
Contact person for scientific queries
Name 8258 0
Dr J. Haxby Abbott
Address 8258 0
Centre for Musculoskeletal Outcomes Research
Orthopaedic Surgical Sciences Department
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country 8258 0
New Zealand
Phone 8258 0
+64 3 474-0999 ext.58615
Fax 8258 0
+64 3 474-7617
Email 8258 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Incremental Effects of Manual Therapy or Booster Sessions in Addition to Exercise Therapy for Knee Osteoarthritis: A Randomized Clinical Trial.2015https://dx.doi.org/10.2519/jospt.2015.6015
EmbaseAre manual therapy or booster sessions worthwhile in addition to exercise therapy for knee osteoarthritis: Economic evaluation and 2-year follow-up of a randomized controlled trial.2021https://dx.doi.org/10.1016/j.msksp.2021.102439
N.B. These documents automatically identified may not have been verified by the study sponsor.