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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

22/12/2020

Date data sharing statement initially provided

16/09/2019

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Ankle Instability

Condition category

Condition code

Musculoskeletal

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]

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]

Self -reported function will be assessed using the Foot and Ankle Ability Measure (FAAM) questionnaire

Timepoint [1]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion

Primary outcome [2]

Position of the fibula will be determined using a lateral pain X-ray in weight bearing position

Timepoint [2]

Baseline (pre- intervention), and at 4th week after enrolment,

Secondary outcome [1]

Weight bearing dorsiflexion range of motion of the ankle

Timepoint [1]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion

Secondary outcome [2]

Pressure pain threshold at points around the ankle and also remotely measured using a pressure algometer

(This is a composite outcome)

Timepoint [2]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion

Secondary outcome [3]

Pain intensity will be measured using visual analogue (VAS) scale

Timepoint [3]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion

Secondary outcome [4]

Static balance will be measured in eyes open and close positions using a force plate

Timepoint [4]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion

Secondary outcome [5]

Dynamic balance will be measured using the Star excursion Balance Test( SEBT) on a force plate

Timepoint [5]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion

Secondary outcome [6]

Patient-Specific Functional Scale (PSFS)

Timepoint [6]

Baseline (pre -intervention), and at 4th week after enrolment, 12th week after intervention completion and 12th month after intervention completion

Secondary outcome [7]

Pain distribution will be recorded using body chart

Timepoint [7]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/11/2017

Actual

6/02/2018

Date of last participant enrolment

Anticipated

Actual

16/07/2018

Date of last data collection

Anticipated

30/12/2019

Actual

30/01/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Newcastle

Address [1]

School of Health Sciences, The University of Newcastle, Callaghan, University Drive, 2308, NSW

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Research Ethics Committee

Ethics committee address [1]

Human research Ethics Administration
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan
NSW 
2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2017

Approval date [1]

01/02/2018

Ethics approval number [1]

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

Prof Darren Rivett

Address

HE13, Hunter Building
School of Health Sciences, University of Newcastle
University Drive
Callaghan, NSW (2308)
Australia

Country

Australia

Phone

(+61 ) 24921 7220

Fax

[email protected]

Contact person for public queries

Name

Suzanne Snodgrass

Address

HC14, Hunter Building
School of Health Sciences, University of Newcastle
Callaghan, NSW(2308)
Australia

Country

Australia

Phone

+(61 )2 492 12089

Fax

[email protected]

Contact person for scientific queries

Name

Peter Osmotherly

Address

HC18, Hunter Building
School of Health Sciences, University of Newcastle
Callaghan, NSW(2308)
Australia

Country

Australia

Phone

(+61 )24921 7718

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual information that is provided will be confidential to the researchers as stated during ethics application

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4787	Study protocol	Weerasekara, I., Osmotherly, P. G., Snodgrass, S. J., Tessier, J., & Rivett, D. A. (2019). Effects of mobilisation with movement (MWM) on anatomical and clinical characteristics of chronic ankle instability: a randomised controlled trial protocol. BMC musculoskeletal disorders, 20(1), 75. doi:10.1186/s12891-019-2447-x	https://www.ncbi.nlm.nih.gov/pubmed/30760256			371712-(Uploaded-14-09-2019-12-34-57)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of mobilisation with movement (MWM) on anatomical and clinical characteristics of chronic ankle instability: A randomised controlled trial protocol.	2019	https://dx.doi.org/10.1186/s12891-019-2447-x
Embase	Feasibility of Using Detuned Laser as a Placebo In Manual Therapy Research: An Analysis of Participant Perceptions.	2022	https://dx.doi.org/10.1016/j.jmpt.2022.04.001

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically