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Trial registered on ANZCTR


Registration number
ACTRN12617001467325
Ethics application status
Approved
Date submitted
10/10/2017
Date registered
17/10/2017
Date last updated
18/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Joint Mobilisation in Chronic Ankle Instability
Scientific title
Effect of Mobilisation with Movement (MWM) on Anatomical and Clinical Characteristics of Chronic Ankle Instability
Secondary ID [1] 290385 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Ankle Instability 300700 0
Condition category
Condition code
Musculoskeletal 300547 300547 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The inferior tibio-fibular joint will be mobilised using Mulligan’s ‘fibula MWM for dorsiflexion and/or inversion in non-weight bearing’. The technique will be applied in supine lying, with the tibia resting on the treatment table and the foot unsupported off the edge of the table. The ankle will be stabilised on the table, while the therapist applies a sustained pain-free anteroposterior glide with a slight cephalad inclination to the distal fibula (lateral malleolus). While the therapist maintains this glide, the patient will be instructed to perform active inversion to the first onset of pain or to end of range (if there is no pain with inversion). At this point, if there is no pain, the therapist will apply overpressure into inversion and maintain the overpressure for 10 seconds. This will be progressed into the weight bearing phase depend on the individual response to the treatment like in the clinical setting.

Treatment will be applied with six to ten repetitions in a set, with three to five sets in a treatment session, with the actual dosage depending on the individual response of the participant. Participants will each receive two to eight treatments over four weeks, The number of treatment sessions for participants of the experimental group will be based on the rate of participants’ symptom reduction, and the clinical judgement of the treating therapist. After each treatment session, Mulligan MWM taping will be applied which attempts to replicate the sustained fibula glide. Non-elastic tape will be applied to the ankle starting 2 cm anterior to the fibula and 1 cm proximal to the tip of the lateral malleolus. The tape will be spiralled obliquely around the lower leg while the fibula glide is sustained, finishing on the anterior aspect. The participant will be asked to keep the tape on for 24 hours unless there is any adverse reaction to the tape. In a case of adverse reaction, they will be asked to remove the tape immediately and note the length of time the tape was in place.
The intervention therapist is an experienced physiotherapist in the field of manual therapy.


Intervention code [1] 296244 0
Rehabilitation
Comparator / control treatment
The placebo intervention will be applied using a detuned therapeutic laser device (Meyer Medical Electronics, Mordialloc, Australia) for five minutes to the lateral region of the ankle, maintaining the probe 0.5-1 cm away from the skin. To the participant, the detuned laser device will appear to function normally both visually and audibly, but it will not produce any effective emission. The detuned laser was chosen as it does not activate somatosensory receptors and it has been shown to have a strong placebo effect.
The number of treatment sessions for participants of the placebo group will be based on the rate of participants’ symptom reduction, and the clinical judgement of the treating therapist.
Control group
Placebo

Outcomes
Primary outcome [1] 300004 0
Self -reported function will be assessed using the Foot and Ankle Ability Measure (FAAM) questionnaire
Timepoint [1] 300004 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion
Primary outcome [2] 300005 0
Position of the fibula will be determined using a lateral pain X-ray in weight bearing position

Timepoint [2] 300005 0
Baseline (pre- intervention), and at 4th week after enrolment,
Secondary outcome [1] 328786 0
Weight bearing dorsiflexion range of motion of the ankle
Timepoint [1] 328786 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion
Secondary outcome [2] 328787 0
Pressure pain threshold at points around the ankle and also remotely measured using a pressure algometer

(This is a composite outcome)
Timepoint [2] 328787 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion
Secondary outcome [3] 328789 0
Pain intensity will be measured using visual analogue (VAS) scale
Timepoint [3] 328789 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion
Secondary outcome [4] 328790 0
Static balance will be measured in eyes open and close positions using a force plate
Timepoint [4] 328790 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion
Secondary outcome [5] 328791 0
Dynamic balance will be measured using the Star excursion Balance Test( SEBT) on a force plate
Timepoint [5] 328791 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion
Secondary outcome [6] 339688 0
Patient-Specific Functional Scale (PSFS)
Timepoint [6] 339688 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion
Secondary outcome [7] 339689 0
Pain distribution will be recorded using body chart
Timepoint [7] 339689 0
Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion

Eligibility
Key inclusion criteria
Standard inclusion criteria endorsed, as a minimum, by the International Ankle Consortium for enrolling patients that fall within the heterogeneous condition of chronic ankle instability in controlled research (Gribble, Delahunt et al. 2014)
1. A history of at least 1 significant ankle sprain
The initial sprain must have occurred at least 12 months prior to study enrollment
Was associated with inflammatory symptoms (pain, swelling, etc)
Created at least 1 interrupted day of desired physical activity
The most recent injury must have occurred more than three months prior to study enrollment.
2. A history of the previously injured ankle joint ‘‘giving way’’ and/or recurrent sprain and/or ‘‘feelings of instability.’’
Specifically, participants should report at least 2 episodes of giving way in the 12 months prior to study enrollment.
Specifically, self-reported ankle instability should be confirmed with a validated ankle instability specific questionnaire using the associated cut-off score.
-Cumberland Ankle Instability Tool (CAIT)- less than or equal to 24
3. A general self-reported foot and ankle function questionnaire to describe the level of disability of the cohort;
-Foot and Ankle Ability Measure (FAAM): ADL scale, less than or equal to 90%, Sport scale, less than or equal to 80 %
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity
• A history of a fracture in either limb of the lower extremity requiring realignment
• Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
They will also be excluded if they have conditions for which:
• manual therapy is generally contraindicated (such as the presence of a tumour, fracture, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, or severe vascular disease)
• radiological imaging is contraindicated (e.g. pregnancy)
• taping is contraindicated (e.g. allergy to strapping tape
and receiving concurrent treatment (the most recent treatment for the ankle condition should have received at least a week prior to study enrolment), and inability to read 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)
Computer generated randomisation schedule for 34 participants, will be concealed in sealed opaque envelopes by another researcher who does not involve in data collection. These envelopes contains a paper with ‘1’ or ‘0’; in which ‘1’ denote ‘MWM’ group and ‘0’ denotes ‘Placebo’ group. The treating physiotherapist will be opened the envelope and allocated the participants according to the number in envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated (SPSS,) randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Continuous data will be assessed for normality using the Shapiro-Wilk test. Comparison of each characteristic between groups at each time point will be analysed using the independent t-test or non-parametric equivalent, as appropriate.

Recruitment
Recruitment status
Active, not 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)
NSW

Funding & Sponsors
Funding source category [1] 294818 0
University
Name [1] 294818 0
The University of Newcastle
Address [1] 294818 0
School of Health Sciences, The University of Newcastle, Callaghan, University Drive, 2308, NSW
Country [1] 294818 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
School of Health Sciences, The University of Newcastle, Callaghan, University Drive, 2308, NSW
Country
Australia
Secondary sponsor category [1] 295663 0
None
Name [1] 295663 0
Address [1] 295663 0
Country [1] 295663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296207 0
University of Newcastle Research Ethics Committee
Ethics committee address [1] 296207 0
Human research Ethics Administration
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan
NSW
2308
Ethics committee country [1] 296207 0
Australia
Date submitted for ethics approval [1] 296207 0
30/10/2017
Approval date [1] 296207 0
01/02/2018
Ethics approval number [1] 296207 0

Summary
Brief summary
The purpose of this study is to,
1. Assess the effect of MWM on fibular positional fault in CAI
2. Evaluate the effectiveness of MWM on clinically relevant outcomes (dorsiflexion range, pressure pain threshold, pain intensity, function, static and dynamic balance)

Participants aged over 18 years will be recruited from the general community in the Newcastle area of New South Wales, Australia and volunteers with CAI will be accepted into the study if they satisfy the inclusion and exclusion criteria as endorsed by the International Ankle Consortium. They will also be excluded if they have conditions for which manual therapy, taping or radiographs are contraindicated. All physiotherapy undergraduates, except first year students also be excluded.
The initial screening will be performed over the telephone after the potential participant contacts the research team. The screening questions are based on injury history. If a potential participant appears eligible following the telephone interview, further screening will be performed using Qualtrics survey tool. Survey link with two questionnaires: the Foot and Ankle Ability Measure (FAAM) and the Cumberland Ankle Instability Tool (CAIT), will be sent, along with the participant information statement and the consent form, through an email. Once the eligibility decided, (CAIT less than or equal to 24, FAAM: ADL < 90%, FAAM: Sports <80 %), the participant will be contacted to schedule an appointment for data collection.
Consenting participants will be randomised into two groups: an experimental group (MWM), and a placebo group (detuned laser). All of the participants will be assessed for general joint hypermobility using the Beighton score. Mechanical ankle instability will be tested using two X-rays taken while performing an anterior drawer stress test. The clinically important outcome measures will include; radiological imaging of fibular position, dorsiflexion range of motion, pressure pain threshold, pain intensity, function, static balance and dynamic balance. Researcher who collect the measurements, and the radiographer will be blinded to the treatment allocation. Due to the nature of the intervention, treating physiotherapist cannot be blinded. Further, the participant does not know which treatment is the active intervention.
Then according to the random allocation; the participant will receive a MWM or a placebo intervention. Participants will receive between 2- 8 intervention sessions over 4 weeks, depend on the clinical judgement of the treating therapist on individual response. The same measures will be repeated at the fourth week after enrolment. Follow up data collection will be carried out after twelfth week, and after twelfth month of the intervention.
Telephone interviews will be conducted in every 4 weeks after enrolment up to one year. These will be made to record new injuries, any treatment co-interventions and the level of engagements in sports and other activities
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69906 0
Prof Darren Rivett
Address 69906 0
HE13, Hunter Building
School of Health Sciences, University of Newcastle
University Drive
Callaghan, NSW (2308)
Australia
Country 69906 0
Australia
Phone 69906 0
(+61 ) 24921 7220
Fax 69906 0
Email 69906 0
darren.rivett@newcastle.edu.au
Contact person for public queries
Name 69907 0
A/Prof Suzanne Snodgrass
Address 69907 0
HC14, Hunter Building
School of Health Sciences, University of Newcastle
Callaghan, NSW(2308)
Australia


Country 69907 0
Australia
Phone 69907 0
+(61 )2 492 12089
Fax 69907 0
Email 69907 0
suzanne.snodgrass@newcastle.edu.au
Contact person for scientific queries
Name 69908 0
Dr Peter Osmotherly
Address 69908 0
HC18, Hunter Building
School of Health Sciences, University of Newcastle
Callaghan, NSW(2308)
Australia
Country 69908 0
Australia
Phone 69908 0
(+61 )24921 7718
Fax 69908 0
Email 69908 0
peter.osmotherly@newcastle.edu.au

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