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Trial registered on ANZCTR


Registration number
ACTRN12609000214235
Ethics application status
Approved
Date submitted
27/02/2009
Date registered
27/04/2009
Date last updated
27/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the immediate effects of Mobilisation with Movement on patients with osteoarthritis of the knee
Scientific title
Assessing the effects of Mobilisation with Movement, placebo and control interventions on knee pain and function in patients with osteoarthritis of the knee
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 4641 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4642 4642 0 0
Physiotherapy
Musculoskeletal 4943 4943 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment condition has three levels: manual therapy, a placebo and a control condition. Participants will experience each treatment condition in a random order over three separate sessions. Participants will attend at approximately the same time of day on three occasions, each separated by at least 24 hours in order to control for carry-over effects.
'Mobilisation with Movement' manual therapy technique: This will consist of a passive glide (MWM) to the affected knee with a superimposed active movement in partial weight-bearing. The participant will be positioned in standing with the foot of the affected side resting on a 10 cm block. The therapist will stand beside the participant on the affected side. The therapist’s hands will hold around the distal femur and proximal lower leg region (fibula and tibia and surrounding soft tissues). The therapist will apply a sustained, passive mobilisation glide to the tibia relative to the femur, whilst the participant is asked to actively move the affected knee into flexion until the point of stiffness or onset of pain, with care by the therapist to avoid any skin areas that are hyperalgesic to touch. The direction of the glide (medial/lateral, anterior/posterior or rotary) will be decided pragmatically by the treating therapist as the one giving greatest pain relief and/or improvement in range of motion. Three sets of 10 repetitions will be applied with a rest interval of one minute between each set. The participant will be instructed that the MWM procedure, including knee flexion, is to be pain free, and must be ceased immediately if any pain is experienced during the application. If a pain-free technique cannot be achieved in weight-bearing, then the same technique will be applied with the participant lying supine (non-weight-bearing) on the treatment bed.
Intervention code [1] 4403 0
Treatment: Other
Comparator / control treatment
placebo manual therapy technique and control (no-treatment):
The placebo condition will replicate the treatment condition except for the hand positioning. The participant and therapist will stand in the same position as the treatment condition, with the therapist’s hands placed comfortably around the distal thigh. A simulated glide will be performed through minimal compressive pressure applied to the thigh. No joint glide will be achieved in the placebo condition. The participant will be asked to bend the affected knee through half of their available pain-free range to minimise the likelihood of pain provocation. The number of repetitions and sets will be as per the treatment group.
Control: The participant will be standing for the same length of time as the other two interventions, but no manual contact between the therapist and the participant will take place.
Control group
Placebo

Outcomes
Primary outcome [1] 5514 0
pain severity on weight bearing knee flexion:
Participants will be asked to indicate the level of pain experienced on a Visual Analogue Scale (VAS) during the lunge task on the affected side. This VAS is anchored with ?no pain? at 0 mm and ?worst pain imaginable? at 100 mm and the distance in millimetres along the line will be manually recorded.
Timepoint [1] 5514 0
pre-intervention and immediately post-intervention
Primary outcome [2] 5791 0
weight bearing knee flexion range of movement to onset of pain:
A previously validated technique using a digital camera will be used to measure ROM of the knee. Adhesive markers will be placed on the skin overlying the following bony landmarks: (1) the lateral femoral epicondyle; (2) the greater trochanter; and (3) the lateral malleolus. The lens of the digital camera will be aligned with the joint line of the knee using a spirit level, and at a set distance of 150cm from the knee joint. A digital photograph will then be taken of the leg at the limit of pain-free knee ROM. The digital images will be downloaded onto a desktop computer and the mean calculation of knee angle in the sagittal plane will be obtained using a validated software program (Software Posture Analysis v1.0.17).
The participant will be positioned in standing with the foot of the tested side placed on a 10 cm block directly in front. The participant will be asked to lunge forward onto a bent knee, transferring their body weight onto the front leg on the block until the first onset of discomfort. The starting distance between their feet will be self-selected by each individual participant, and this distance will be measured and used for repeated assessments to ensure a standardised starting position. A digital photograph will be taken at the limit of knee flexion ROM. The process will be repeated three times with an intervening 30-second rest interval, for both the affected and unaffected sides.
Timepoint [2] 5791 0
pre-intervention and immediately post-intervention
Secondary outcome [1] 9279 0
pressure pain threshold:
Pressure pain threshold will be measured using a pressure algometer. Pressure will be applied to the medial knee joint line via a digital pressure algometer. The pressure algometer utilises a load cell (XTRAN S1W - 250 N; Applied Measurement, Australia) and a hand switch connected to a portable computer via a Data Acquisition Card (USB6009 DAQ; National Instruments, Texas USA). The processing software is LabView 7.1 (National Instruments, Texas USA). Load will be applied at a rate of 40 kPa/s through a rubber-tipped probe (area 1 cm2). The patient will be asked to activate a button as soon as a change in sensation from one of pressure to one of pain is experienced (threshold of pain). This process will be repeated three times with a 30-second rest period between each measurement, for both the affected and unaffected sides.
Timepoint [1] 9279 0
pre-intervention and immediately post-intervention
Secondary outcome [2] 241785 0
Non-weight bearing knee flexion/extension range of movement to onset of pain:
With the participant lying supine on a treatment bed, the lens of the digital camera will be aligned with the joint line of the knee using a spirit level, and at a set distance of 150cm from the knee joint. A digital photograph will then be taken of the leg at the limit of pain-free knee flexion ROM and extension ROM. The process will be repeated three times in each position with an intervening 30-second rest interval. This process will then be repeated for the opposite side.
Timepoint [2] 241785 0
pre-intervention and immediately post-intervention

Eligibility
Key inclusion criteria
Clinical diagnosis of medial compartment osteoarthritis (OA) of the knee, according to the American College of Rheumatology classification for knee OA: regular experience of knee pain (minimum of 4/10 on a visual analogue scale), medial compartment osteophytes on radiograph (as assessed by an experienced radiologist), reports of morning stiffness or crepitus and pain or difficulty rising from a chair or climbing stairs.
Minimum age
35 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of lower limb surgery, physiotherapy or intra-articular knee injections within the last 6 months, a co-existing systemic condition, severe medical condition, inflammatory or neurological conditions, previous knee replacement or resurfacing surgery on the affected limb, if the patient has experienced altered sensation around their knee, or exhibit cognitive difficulties

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)
A research investigator will screen potential participants for eligibility, based
on the inclusion/exclusion criteria, via an initial interview. Once informed consent is obtained, participants will receive all three intervention conditions in a random order. A computer-generated randomisation schedule will be drawn up with the order of intervention randomised and administered via concealed allocation (sealed opaque envelopes). This process will be carried out by a research investigator who is independent of the outcome assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
A repeated-measures, crossover, placebo controlled, randomised design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4853 0
Other Collaborative groups
Name [1] 4853 0
Australian Physiotherapy Association
Country [1] 4853 0
Australia
Primary sponsor type
Individual
Name
Dr Leanne Bisset
Address
School of Physiotherapy & Exercise Science,
Griffith University,
Gold Coast Campus. Qld 4222
Country
Australia
Secondary sponsor category [1] 4390 0
Hospital
Name [1] 4390 0
Royal Brisbane and Women's Hospital
Address [1] 4390 0
Physiotherapy Dept
Royal Brisbane and Women's Hospital
Butterfield St
Herston. QLD 4029
Country [1] 4390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6911 0
Royal Brisbane and Women's Hospital HREC (EC00172)
Ethics committee address [1] 6911 0
Ethics committee country [1] 6911 0
Australia
Date submitted for ethics approval [1] 6911 0
Approval date [1] 6911 0
02/04/2009
Ethics approval number [1] 6911 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29333 0
Address 29333 0
Country 29333 0
Phone 29333 0
Fax 29333 0
Email 29333 0
Contact person for public queries
Name 12580 0
Dr Leanne Bisset
Address 12580 0
School of Physiotherapy & Exercise Science,
Griffith University,
Gold Coast Campus. Qld 4222
Country 12580 0
Australia
Phone 12580 0
+61 7 55527717
Fax 12580 0
+61 7 55528674
Email 12580 0
l.bisset@griffith.edu.au
Contact person for scientific queries
Name 3508 0
Dr Leanne Bisset
Address 3508 0
School of Physiotherapy & Exercise Science,
Griffith University,
Gold Coast Campus. Qld 4222
Country 3508 0
Australia
Phone 3508 0
+61 7 55527717
Fax 3508 0
+61 7 55528674
Email 3508 0
l.bisset@griffith.edu.au

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
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Documents added automatically
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