None listed
Conditions
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
Interventions
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 maint
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.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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 %
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
Outcome results
None listed