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Trial registered on ANZCTR


Registration number
ACTRN12614000419662
Ethics application status
Approved
Date submitted
10/04/2014
Date registered
16/04/2014
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of fibular mobilisation with movement and tape for the treatment of ankle inversion sprains: A randomised clinical trial
Scientific title
Efficacy of fibular mobilisation with movement and tape for the treatment of ankle inversion sprains: A randomised clinical trial
Secondary ID [1] 283896 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grade II sprain of the lateral collateral ligament of the ankle 290886 0
Condition category
Condition code
Musculoskeletal 291240 291240 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291992 291992 0 0
Physiotherapy
Injuries and Accidents 292037 292037 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1. Distal fibular mobilisation with movement - This treatment technique involves the application of a posterior-lateral and superior glide over the distal end of the fibula that is then maintained while the subject actively inverts the ankle to the end of pain-free range. If full pain-free range is achieved, overpressure is applied by the therapist (Vicenzino et al., 2011). 3 sets of 10 repetitions have been found to provide an immediate improvement in ROM and function (Merlin, McEwan, & Thom, 2005). In addition to this treatment, a posterior gliding fibular tape will be used. This will be in the form of two diagonal strips of non-stretch tape at the level of the tibiofibular joint applying a posterior-superior glide to the fibula. This has been advocated for the prevention and treatment of lateral ankle sprains (Hopper et al., 2009). Moiler, Hall and Robinson (2006) found the posterior gliding fibular tape to reduce the incidence of ankle sprains in basketball players when compared to other forms of prophylactic methods including traditional ankle taping and ankle bracing.

Group 2. This group will only have the distal fibular mobilisation with movement and not the posterior gliding fibular tape that is being used in Group 1.

The mobilisations and the posterior gliding tape will be applied for a maximum of 3 times per week for 2 weeks. The mobilisations and the posterior gliding tape will be discontinued before the end of week 2 if full pain-free range of movement has been restored. Discontinuation of mobilisations and posterior gliding tape will be decided by the investigator measuring the outcome measures, who will be blind to the treatment allocation of the subject. The discontinuation of mobilisations and tape will be recorded, and used itself as a measure of the effectiveness of each intervention.

Proprioceptive exercises will start in week 3 at the latest. When mobilisations and the posterior gliding tape are discontinued prior to the end of week 2, proprioceptive exercises will start as soon as treatment with mobilisations and tape is discontinued. These exercises involve standing on uneven surfaces while being challenged with environmental and external stimuli/perturbations, starting with less difficult challenges and progressing as balancing ability improves. This is a standard physiotherapy treatment following ankle sprains and is usually done daily and at training sessions as a warm up when returning to sport. The exercises should take about 15-20 minutes each session.

All subjects (in all three intervention groups) will receive 20 minutes of TENS (50-100Hz, pulse width 150microseconds) and 5 minutes of oedema draining massage. This will be administered after the distal fibular mobilisation with movement treatment and before the application of tape in Group 1. All groups will also receive general advice on self management of their ankle injury (i.e., ice, elevation).

Proprioception exercises, which have been found to significantly reduce injury recurrence (Hupperets, Verhagen, & van Mechelen, 2009), will also be included in all groups.

Adherence will be monitored through regular physiotherapy visits and interviews in the first 5 weeks (weekly visits in weeks 3, 4, 5) and then by email or phone communication.
Intervention code [1] 288572 0
Rehabilitation
Intervention code [2] 289194 0
Treatment: Other
Comparator / control treatment
3. Anterior-posterior mobilisation of the talocrural joint - With the subject lying in supine, a posteriorly directed mobilisation of the talus will be performed as described by Green et al (2001). Green et al (2001) found that posteriorly directed mobilisations of the talus were more effective at reducing the number of required treatments (and hence time to discharge), improving ankle ROM and increasing stride speed during gait than a treatment that involved a protocol of rest, ice, compression and elevation (RICE).

The mobilisation will be performed with the foot positioned at the end of the available pain-free dorsiflexion. The mobilisation will involve a gentle small amplitude oscillatory technique at a frequency of approximately 1 Hz, and will be performed without reproducing any pain or spasm. The mobilisation will be performed for three sets of 60 repetitions with a 10 second rest period in between sets. As the patient improves between sessions, the technique will be progressed by increasing the amount of foot dorsiflexion in which the technique is performed.

All subjects (in all three intervention groups) will receive 20 minutes of TENS (50-100Hz, pulse width 150microseconds) and 5 minutes of oedema draining massage. This will be performed after the anterior-posterio mobilisation of the talocrural joint. This group will also receive general advice on self management of their ankle injury (i.e., ice, elevation).

The mobilisation (3 x 60) will be applied for a maximum of 3 times per week for 2 weeks and will be discontinued before the end of week 2 if full pain-free range of movement has been restored. Discontinuation of mobilisations will be decided by the investigator measuring the outcome measures, who will be blind to the treatment allocation of the subject. The discontinuation of mobilisations and tape will be recorded, and used itself as a measure of the effectiveness of each intervention.

Adherence will be monitored through regular physiotherapy visits and interviews in the first 5 weeks (weekly visits in weeks 3, 4, 5) and then by email or phone communication.
Control group
Active

Outcomes
Primary outcome [1] 291238 0
Global rating of change (GROC) - A Patient Global Impression of Improvement Scale (PGI-I) will be used to measure the overall change of the patient. The PGI-I is a seven-point categorical scale, where the patient can rate their overall change since the start of the treatment (Farrar, Young, LaMoreaux, Werth, & Poole, 2001). Patients will be asked to choose a point in the scale that ranges from “very much improved” to “very much worse. The Spanish version of the scale developed by the Spanish Pain Society (Sociedad Espanola del Dolor) will be used.
Timepoint [1] 291238 0
End of Week 2, Week 5, Week 12
Primary outcome [2] 291239 0
Foot and Ankle Ability Measure (FAAM) - The FAAM will be used to assess the participant´s change in function during the treatment. The FAAM has been used previously to assess the effect of treatment on patients with ankle injuries (Gilbreath, Gaven, Van Lunen, & Hoch, 2013), and has been found to be a valid and reliable measurement tool for ankle function (Martin, Irrgang, Burdett, Conti, & Van Swearingen, 2005). The FAAM consists of 29 items separated into two subscales: a 21-item activities of daily living subscale and a 8-item sports subscale. Each item is scored on a 5 point Likert scale ranging from “no difficulty” to “unable to do”. Lower scores are indicative of greater levels of functional loss.
Timepoint [2] 291239 0
Baseline, End of Week 2, Week 5, Week 12, Week 52, Week 104
Secondary outcome [1] 306306 0
When a treatment is applied, all measurements will be performed at the beginning of the treatment session. Measurements will be performed by an investigator blind to the group allocation of the participant.

Ankle and foot range of movement (ROM):-

Weight bearing Dorsiflexion - Weight bearing ankle dorsiflexion ROM will be measured using the knee-to-wall measurement. This measurement has been widely used to measure ankle ROM (Collins, Teys, & Vicenzino, 2004) and has been reported to have very good intra-rater reliability (Konor, Morton, Eckerson, & Grindstaff, 2012).
The participant will stand with their foot perpendicular to a wall and will be instructed to gradually dorsiflex their foot to a position where the knee touches the wall whilst maintaining the heel in contact with the floor. Participants will be asked to dorsiflex their foot to the point permitted by their symptoms. No attempts will be made to control or limit foot pronation or supination. The distance between the first toe and the wall will be used as a measure of the participant's ankle dorsiflexion ROM.

Timepoint [1] 306306 0
Baseline, End of Week 2
Secondary outcome [2] 306307 0
Pain:
1. Visual analogue scale - The visual analogue scale, a 10cm line with the two end points representing ‘no pain’ and ‘worst pain imaginable’ will be used as a measure of pain. The patients will be asked to rate the average and the maximum pain in the last 24 hours. Patients will be asked to make a mark representing their pain. The distance in cm from the “no pain” marker to the mark drawn by the patient will be used as the measure of the participant´s pain (Hawker, Mian, Kendzerska, & French, 2011).

Timepoint [2] 306307 0
Baseline, End of Week 2, Week 5, Week 12
Secondary outcome [3] 306310 0
Ankle and foot volume - A volumeter will be used to measure ankle and foot volume. The measurement will be taken in sitting for patient comfort and safety. Foot and ankle water volumetry has been to shown to have very good reliability (Petersen et al., 1999), and offer a higher responsiveness to change than other methods of volume measurement (Henschke, Boland, & Adams, 2006).
Timepoint [3] 306310 0
Baseline, End of Week 2
Secondary outcome [4] 306311 0
Ankle eversion muscle strength - Strength of the ankle evertors will be measured using a hand-held dynamometer (HHD). A systematic review by (Stark, Walker, Phillips, Fejer, & Beck, 2011) found hand-held dynamometry to be both valid and reliable for the measurement of muscle strength. Participants will be positioned in a long sitting position with their feet over the edge of the plinth, and the HHD will be positioned against the lateral border of the 5th metatarsal head. Participants will be instructed to perform an isometric ankle eversion against the HDD for 5 seconds. An average of 3 repetitions separated by two 10-second rest periods will be used as a measure of ankle eversion strength. The participants will be allowed a submaximal familiarisation contraction prior to testing (Carroll, Joyce, Brenton-Rule, Dalbeth, & Rome, 2013).
Timepoint [4] 306311 0
Baseline, End of Week 2, Week 5
Secondary outcome [5] 306312 0
Balance - With the subject standing on one leg over a stabilometer (force platform), the displacement of the centre of pressure will be used to assess the balance (Hopper et al., 2009).
Timepoint [5] 306312 0
End of Week 2, Week 5, Week 12
Secondary outcome [6] 306313 0
Recurrence rate will be recorded by medical staff attending to any of the participants who re-sprain their ankle within the study period. This data will be collected on a questionnaire.
Timepoint [6] 306313 0
Week 12, Week 52, Week 104
Secondary outcome [7] 307827 0
Ankle and foot range of movement (ROM):-
2. Plantar Flexion Range of Movement: - The protocol described by Nunes et al (2012) will be used to measure plantar flexion ROM. This protocol has shown very good intra-tester reliability, and greater reliability than other methods such as goniometry and static image analysis. The participant will be positioned in a supine position and instructed to slide the foot on the plinth, whilst extending the knee and maintaining full contact between the sole of the foot and the plinth. The moment the sole of the foot looses contact with the plinth, the patient will be instructed to stop the movement and the measurement will be performed. The distance between the highest point on the knee and the plinth, and the horizontal distance between the most posterior aspect of the calcaneus and the projection of the vertical distance will be recorded. Ankle plantar flexion angle will be calculated by trigonometry.
Timepoint [7] 307827 0
Baseline, End of Week 2
Secondary outcome [8] 307828 0
Ankle and foot range of movement (ROM):-
3.Inversion and Eversion Range of movement-
Inversion and eversion ROM will be measured in prone using a hand-held goniometer as described by Menadue et al (2006). This measurement protocol has been shown to have moderate to good between-session within-observer reliability. With the foot over the edge of the plinth, the ankle will be allowed to rest in plantar flexion. The participant will be instructed to move the foot to maximum ankle eversion and then inversion, and the ROM in each direction will be measured. The axis of the goniometer will be positioned at the midpoint between the malleoli. The angle formed between a line bisecting the posterior aspect of the lower leg and a line bisecting the posterior aspect of the calcaneus will be used to measure eversion and inversion ROM.
Timepoint [8] 307828 0
Baseline, End of Week 2
Secondary outcome [9] 307829 0
Pain:
2. Pressure pain threshold (PPT) - PPT will be measured at two sites: directly distal to the lateral malleolus over the calcaneofibular ligament, and directly anterior to the lateral malleolus over the anterior talofibular ligament (Collins et al., 2004). The test will be performed first (twice) on the anterior talofibular ligament of the unaffected ankle in order to first familiarise the participant with the procedure. PPT will be defined as the amount of pressure required to elicit the first onset of a sensation of pain that is distinct from pressure or discomfort. Pressure with the algometer will be increased at a rate of 5 Newtons per second. An average of three measurements performed 15 seconds apart will be calculated to reflect PPT at each measured site (Chesterton, Sim, Wright, & Foster, 2007).
Timepoint [9] 307829 0
Baseline, End of Week 2, Week 5, Week 12

Eligibility
Key inclusion criteria
Amateur football players with a Grade II sprain of the lateral collateral ligament of the ankle presenting to the Vizcay Association of Football following an acute inversion injury (maximum 72 hours post injury) will be invited to take part in the study. (A Grade II sprain is defined as a partial tear of the ligaments with moderate pain, swelling and tenderness over the involved structures with some loss of motion and mild or moderate instability of the joint (Kaikkonen, Kannus, & Jarvinen, 1994)).
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if:
1. They have a history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either lower extremity (Gribble et al., 2013).
2. They have a history of a fracture in either lower extremity requiring realignment (Gribble et al., 2013).
3. They have sustained an acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months that have impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity (Gribble et al., 2013).
4. They have sustained an ankle sprain in the previous 12 months from the date of the current ankle inversion injury (Green, Refshauge, Crosbie, & Adams, 2001).

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)
On their initial visit, participants will be assessed for their response to a distal fibula repositioning manoeuvre. Ankle joint inversion with and without the application of the distal repositioning manoeuvre will be assessed. This manoeuvre involves the manual application of a sustained postero-lateral and superior glide over the distal fibula while the subject actively inverts the ankle to the end of pain-free range (Vicenzino, Hall, & O´Brien, 2011) . If the patient reports an immediate improvement in symptoms elicited during active ankle inversion while the manoeuvre is applied in comparison to their previous attempt when no manoeuvre was applied, the patient will be classified as respondent. If the manoeuvre causes no immediate improvement in symptoms or the symptoms worsen, the patient will be classified as non-respondent. In order for the patient to be classified as respondent, the patient will need to report a minimum of 50% symptom improvement during the manoeuvre.
Respondents and non-respondents will be equally stratified into all three treatment groups.
Once the subject has been stratified and enrolled into the study, the therapist will open a sealed envelope which contains the randomised treatment group (for each stratification). This will provide for concealment of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
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
A pilot study consisting of 21 subjects will be carried out to test the study methodology and also to obtain context specific estimates of the effect size that will be used in power calculations to determine the final sample size. It is anticipated that approximately 90 subjects will be required for the main study.
Following the pilot study, the effect size will be used in power calculations to determine the final sample size. Once data collection is completed, a quantitative analysis will be performed. The effectiveness of the treatments will be analysed in relation to the recorded primary and secondary outcome measures. In addition, the ability of the distal fibula repositioning manoeuvre to predict treatment outcome will be explored.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/04/2014
Actual
13/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 5746 0
Spain
State/province [1] 5746 0
Leioa

Funding & Sponsors
Funding source category [1] 288551 0
Self funded/Unfunded
Name [1] 288551 0
N/A
Country [1] 288551 0
Primary sponsor type
University
Name
University of the Basque Country
Address
Barrio Sarriena, s/n
Leioa 48940
Country
Spain
Secondary sponsor category [1] 287263 0
None
Name [1] 287263 0
N/A
Address [1] 287263 0
N/A
Country [1] 287263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290850 0
University of the Basque Country Ethics Committee for research related to Humans
Ethics committee address [1] 290850 0
Ethics committee country [1] 290850 0
Spain
Date submitted for ethics approval [1] 290850 0
Approval date [1] 290850 0
13/03/2014
Ethics approval number [1] 290850 0

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

Contacts
Principal investigator
Name 45506 0
Mr Ion Lascurain-Aguirrebena
Address 45506 0
Department of Physiology
Faculty of Medicine and Odontology
University of the Basque Country
Barrio Sarriena, s/n
Leioa 48940

Country 45506 0
Spain
Phone 45506 0
+34 946017947
Fax 45506 0
Email 45506 0
[email protected]
Contact person for public queries
Name 45507 0
Bill Vicenzino
Address 45507 0
School of Health and Rehabilitation Sciences
Department of Physiotherapy
University of Queensland,
St Lucia, Qld. 4072
Country 45507 0
Australia
Phone 45507 0
+61 7 33652781
Fax 45507 0
Email 45507 0
[email protected]
Contact person for scientific queries
Name 45508 0
Bill Vicenzino
Address 45508 0
School of Health and Rehabilitation Sciences
Department of Physiotherapy
University of Queensland,
St Lucia, Qld. 4072
Country 45508 0
Australia
Phone 45508 0
+61 7 33652781
Fax 45508 0
Email 45508 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
EmbaseEffectiveness of Mobilization of the Talus and Distal Fibula in the Management of Acute Lateral Ankle Sprain.2021https://dx.doi.org/10.1093/ptj/pzab111
N.B. These documents automatically identified may not have been verified by the study sponsor.