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Trial registered on ANZCTR


Registration number
ACTRN12610000660088
Ethics application status
Approved
Date submitted
10/08/2010
Date registered
12/08/2010
Date last updated
12/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of neuromuscular exercise in the treatment of knee osteoarthritis.
Scientific title
The effect of neuromuscular exercise on pain, physical function and dynamic knee loading in people with knee osteoarthritis.
Secondary ID [1] 252127 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 257240 0
Condition category
Condition code
Musculoskeletal 257377 257377 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participant will be randomised into one of two groups: (i) neuromuscular training; (ii) quadriceps strengthening.

(i) Neuromuscular training group
This intervention will comprise individual visits (up to twice weekly) to a physiotherapist located around Melbourne over 12 weeks, plus home exercises to be performed up to 5 times a week. Each physiotherapy session will last approximately 40 minutes. The exercises include closed kinetic chain, functional and balance exercises which aim to improve dynamic stability, functional alignment and muscle activation patterns. A comprehensive exercise manual will be produced. Various equipment, including elastic bands will be used for some of the exercises. Progression of the exercises will be determined by the quality of the exercise performance and partly on participants' pain levels.
(ii) Quadriceps strengthening group
This intervention will comprise individual visits (up to twice weekly) to a physiotherapist located around Melbourne over 12 weeks, plus home exercises to be performed up to 5 times a week. Each physiotherapy session will last approximately 30 minutes. A comprehensive exercise manual will be produced. Open kinetic chain quadriceps strengthening exercises will be performed with resistance provided by ankle weights or elastic bands. Progression will be determined by the therapist taking into account the participant’s strength gain and pain levels.
Intervention code [1] 256357 0
Rehabilitation
Comparator / control treatment
We are using the standard treatment of quadriceps strengthening as our control group.
Control group
Active

Outcomes
Primary outcome [1] 258288 0
Pain measured with a 100mm Visual Analog Scale (VAS), by the Western Ontario and McMasters (WOMAC) Osteoarthritis questionnaire, the Knee Osteoarthritis Outcome Score (KOOS), and global rating of change in pain on a 7-point scale (1=much worse, 2-moderately worse, 3=slightly worse, 4=no change, 5=slightly better, 6=moderately better, 7=much better).
Timepoint [1] 258288 0
VAS, WOMAC and KOOs questionnaires will be administered at baseline and 12 weeks. The global rating of change will be administered at 12 weeks.
Primary outcome [2] 258289 0
Physical function measured with the WOMAC Osteoarthritis questionnaire, the KOOS,and global rating of change in physical function on a 7-point scale (1=much worse, 2-moderately worse, 3=slightly worse, 4=no change, 5=slightly better, 6=moderately better, 7=much better).
Timepoint [2] 258289 0
WOMAC and KOOs questionnaires will be administered at baseline and 12 weeks. The global rating of change will be administered at 12 weeks.
Primary outcome [3] 258770 0
Dynamic loading of the knee during walking and stair climbing, as represented by the Knee Adduction Moment (KAM). The participants will be asked to walk back and forth along a 10m level pathway and then to ascend and descend a set of stairs. Movements will be measured using an 8-camera Vicon motion analysis system that collects three-dimensional motion data, and ground reaction force (via a force plate). To enable motion measurements, markers are placed over major body landmarks. Force plates in the floor will collect external forces on the subjects.
Timepoint [3] 258770 0
This will be measured at baseline and at 12 weeks.
Secondary outcome [1] 263973 0
Physical activity levels. We will use the Physical Activity Scale for the Elderly (PASE), a self report questionnaire.
Timepoint [1] 263973 0
These will be administered at baseline and 12 weeks.
Secondary outcome [2] 263974 0
Psychological disability measured using the Anxiety Subscale of the Arthritis Impact Measurement Scales (AIMS) questionnaire.
Timepoint [2] 263974 0
This will be administered at baseline and 12 weeks.
Secondary outcome [3] 263975 0
Self efficacy, pain catastrophising and use of coping skills. The Arthritis Self Efficacy Scale, the Pain Catastrophizing Scale and the Coping Strategies Questionnaire will measure aspects respectively.
Timepoint [3] 263975 0
These will be administered at baseline and 12 weeks.
Secondary outcome [4] 263984 0
Muscle strength. Isometric quadriceps and hamstring strength will be measured at 60 degrees knee flexion using a KinCom isokinetic dynamometer. Hip muscle strength will be measured using an instrumented manual muscle tester. For each muscle group, the participant will perform 3 maximal contractions for a period of 5 seconds each and the best of 3 repetitions will be recorded.
Timepoint [4] 263984 0
These will be performed at baseline and 12 weeks.
Secondary outcome [5] 263985 0
Muscle activation. Electromyography (EMG) electrodes will be placed on the skin over several muscles around the hip and thigh to look at muscle activation. Muscle activation patterns will be measured whilst the person walks along a flat surface and during stair climbing.
Timepoint [5] 263985 0
These will be performed at baseline and 12 weeks.
Secondary outcome [6] 264827 0
Co-interventions, compliance and adverse effects. Participants will be asked to record their completion of home exercises and any adverse effects in a log book. Physiotherapists will be asked to record patient attendance to the treatment sessions.
Timepoint [6] 264827 0
Patients will fill in their log books each time they exercise at home, and will be collected at the 12 week assessment. Attendance records will be collected from the physiotherapists at the end of the initial 12 week period.
Secondary outcome [7] 264828 0
Single limb standing balance. Patients will be asked to stand on their symptomatic leg for as long as they can up to a maximum of 30 seconds. The time up to when the patient had to touch their leg down will be recorded. Two repetitions are given.
Timepoint [7] 264828 0
These will be performed at baseline and 12 weeks.
Secondary outcome [8] 264829 0
Knee joint laxity. While in sitting, the thigh and shin will be restrained by a force and angle measurement device and the knee moved passively from side to side to achieve a fixed force. The resultant angle will be analysed as a measurement of knee joint varus valgus laxity.
Timepoint [8] 264829 0
This will be performed at baseline and 12 weeks.
Secondary outcome [9] 264830 0
Sensory deficits. A vibrometer will be used to supply mechanical stimulation to the lower leg. The patient will be asked to indicate the onset of the stimulus. The vibrometer will be applied to the medial metatarsophalangeal, medial and lateral malleolus and medial and lateral femoral condyles. Pressure pain thresholds using a pressure algometer will be measured at 3 chosen painful sites, and these correspnding sites on the contralateral limb. Measurements will repeated 3 times and averaged.
Timepoint [9] 264830 0
These will be performed at baseline and 12 weeks.
Secondary outcome [10] 265116 0
Quadriceps muscle steadiness. The patients will be asked to hold 3-4 second contractions at 25%, 50% and 75% of their maximum voluntary contraction with the knee position at 60 degrees of flexion. Three repetitions will be performed. The force traces will be assessed for how steady the patient was able to hold their muscles at each level of force.
Timepoint [10] 265116 0
These will be performed at baseline and 12 weeks.

Eligibility
Key inclusion criteria
A cohort of 100 men and women aged over 50 years with painful medial knee osteoarthritis (OA) will be recruited from the community, via notices in local and major newspapers, University of Melbourne Staff News, community club (such as RSL and bowls clubs) newsletters and posters which will be placed in medical, radiology or physiotherapy waiting rooms and advertisements placed in Facebook on the internet. Interested volunteers will telephone study personnel in order to establish initial eligibility for the project. Eligibility will subsequently be confirmed by radiographic and clinical examination. People with medial tibiofemoral joint OA (fulfilling the American College of Rheumatology classification criteria (Altman et al., 1986; Kellgren et al., 1963), a knee alignment of at least 181 degrees varus for women and 183 degrees varus for men and reporting average knee pain >39mm on an 100mm scale will be included.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include: a history of a lower limb joint replacement, high tibial osteotomy, spinal or hip surgery, any physiotherapy, lower limb exercises (including strengthening, pilates, yoga or balance components) or knee surgery or knee injections in the past 6 months, any condition that may affect walking, any systemic arthritic condition, any major medical conditions, such as cancer or major heart trouble, inability to walk unassisted and the inability to understand written or spoken English.

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)
People will be initially screened via telephone. Suitable patients will undergo a knee x-ray to confirm radiographic eligibility criteria. Baseline testing will be performed at the University of Melbourne and the participant will be randomised into one of two groups: (i) neuromuscular training; (ii) quadriceps strengthening. Randomization will be concealed, and the allocation will be performed by opening an opaque envelope after the baseline assessment has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, with stratification for physiotherapist, which will be done with the use of a computer program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256861 0
Government body
Name [1] 256861 0
National Health and Medical Research Council (NH & MRC)
Address [1] 256861 0
Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Country [1] 256861 0
Australia
Primary sponsor type
University
Name
The University of Melbourne, Department of Physiotherapy
Address
200 Berkeley St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 256136 0
None
Name [1] 256136 0
Address [1] 256136 0
Country [1] 256136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258874 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 258874 0
Melbourne Research
The University of Melbourne
Alan Gilbert Building
Parkville VIC 3052
Ethics committee country [1] 258874 0
Australia
Date submitted for ethics approval [1] 258874 0
Approval date [1] 258874 0
16/04/2010
Ethics approval number [1] 258874 0
0932813.1

Summary
Brief summary
Knee osteoarthritis (OA) is a major public health problem. To reduce the burden of this disease, factors that increase the likelihood of disease progression need to be identified and treatments that slow progression need to be developed and tested. This is an emerging area and is the focus of this study because presently there are no established disease-modifying treatments for knee OA. One way to slow progression of the disease may be to reduce knee loading as this is one of only a few modifiable factors currently known to predict disease progression. This study will evaluate whether neuromuscular exercise, which aims to improve balance, alignment of the lower limb and trunk and muscle activity, reduces knee joint loading and thus has the potential to slow disease progression in people with knee OA, compared with the current standard physiotherapy treatment of strengthening the thigh muscles. If shown to be effective, recommendations can then be made to incorporate neuromuscular exercises into rehabilitation programs for knee OA.
Trial website
http://www.physioth.unimelb.edu.au/chesm/nexarct.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31089 0
Address 31089 0
Country 31089 0
Phone 31089 0
Fax 31089 0
Email 31089 0
Contact person for public queries
Name 14336 0
Prof Kim Bennell
Address 14336 0
Centre of Health, Exercise and Sports Medicine,
Department of Physiotherapy
The University of Melbourne
200 Berkeley St
Carlton VIC 3053
Country 14336 0
Australia
Phone 14336 0
+61 3 8344 4135
Fax 14336 0
+61 3 8344 3771
Email 14336 0
k.bennell@unimelb.edu.au
Contact person for scientific queries
Name 5264 0
Prof Kim Bennell
Address 5264 0
Centre of Health, Exercise and Sports Medicine,
Department of Physiotherapy
The University of Melbourne
200 Berkeley St
Carlton VIC 3053
Country 5264 0
Australia
Phone 5264 0
+61 3 8344 4135
Fax 5264 0
+61 3 8344 3771
Email 5264 0
k.bennell@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results