​​The effects of the treatment on the pain and disability caused by osteoarthritis of your big-toe joint will be assessed over a period of 52 weeks (12 months). As a study participant, your involvement will be as follows:

Initial assessment: Appointment where we will determine your suitability to be in the study and provide you with your treatments (90 minutes).

Magnetic resonance imaging (MRI) assessment (within 7 days of the initial assessment): Appointment to determine the presence and severity of any pathology in specific tissues of your big-toe joint (30 minutes to complete).

Week 1 assessment: Appointment to review your treatments and evaluate how you walk with and without your shoe inserts  (90 minutes).
Week 4 assessment: We will assess the pain in your big-toe joint(s) via a questionnaire mailed to you (questionnaire will take approximately 30 minutes to complete).​
Week 12 assessment: Appointment to review your treatments, assess the pain in your big-toe joint(s) (60 minutes).
Week 24 (6 months) assessment: We will assess the pain in your big-toe joint(s) via a questionnaire mailed to you (questionnaire will take approximately 30 minutes to complete).
Week 52 (12 months) assessment: We will assess the pain in your big-toe joint(s) via a questionnaire mailed to you (questionnaire will take approximately 30 minutes to complete). You will also undergo a follow-up (second) MRI assessment of your big toe joint (30 minutes to complete).​
Postal questionnaires at monthly intervals: (will take approximately 10 minutes to complete).
 
Each of these appointments will now be discussed below in more detail.

Initial assessment
To confirm the presence of osteoarthritis of the big-toe joint, an initial assessment will be required. This assessment is expected to take 60 minutes and will involve:

 - clinical assessment of your big-toe joint at the Health Sciences Clinic at La Trobe University, Bundoora;

 - three-dimensional photographs taken of your feet; 

 - one set of x-rays taken of the foot of your painful big-toe joint, to grade the severity of osteoarthritis affecting the big-toe joint. These will be performed by a qualified radiologist at Southern Cross Medical Imaging, La Trobe University Private Hospital, Bundoora.


Once the assessments are complete, the investigator will inform you of your eligibility to participate in this study. If you are eligible, you will be invited to participate in the study and will be randomly allocated to one of two different shoe inserts treatments (see section titled “Treatments” below). This means you have a 50:50 chance of receiving either shoe insert. You will not have a choice as to which insert you receive.


During this appointment, the following will also be assessed using questionnaires:

- the types of pain you are experiencing in your big-toe joint;
- your general health-related quality of life;
- your severity of depression, anxiety and stress;
- how you cope with pain.


Magnetic resonance imaging (MRI):
After this, an appointment will be made (at a date that suits you but within 1 week) for you to undergo a safe and painless imaging technique called magnetic resonance imaging (MRI), to determine the presence and severity of any pathology in specific tissues of your big-toe joint. If you have pain in both big-toe joints of your feet, one foot will be assessed. The MRI scan is a painless procedure that will involve you to lie down on your back between two large scanning plates from your feet to your chest for approximately 30 minutes. MRI scans are not the same as x-rays in that no radiation is involved and therefore pose no risk of harm from ionising radiation. This will be performed by a qualified radiologist and occur at a radiology clinic called
Direct Radiology located at 149-153 Station St, Fairfield).


Week 1 appointment
One week after the initial assessment, you will be asked to return to the Health Sciences Clinic at La Trobe University, Bundoora to review your treatments and ensure you are performing your ‘physical therapy’ exercises correctly.


In addition, during the week 1 appointment, you will to undergo some assessments (in the Gait Laboratory in Health Sciences 3 building at La Trobe University, Bundoora) to evaluate how the treatments influence how you walk. We will attach reflective markers (similar to small table tennis balls) to your legs and feet with adhesive tape.  We will then record you walking along a 10 metre walkway.  There are 10 infrared cameras positioned around the laboratory that will detect the movement of the reflective markers, and from this, a computer program can create an image of dots on a black screen that we can use to measure how you walk.

These tests are non-invasive and will not cause you any discomfort.
 
Week 12 appointment
Twelve weeks after the initial assessment, you will be asked to return to the Health Sciences Clinic at La Trobe University, Bundoora to review your treatments and ensure you are performing your ‘physical therapy’ exercises correctly.

During these appointments, the following will be assessed:

i)          the amount of pain and disability caused by osteoarthritis of your big-toe joint(s);
ii)         your rating as to the amount that your symptoms have changed from the treatment;
iii)         your general health-related quality of life;
iv)        your use of any other treatments to relieve pain in your big-toe joint(s)
v)         your adherence with the treatment(s);
vi)        any adverse events from your treatments;
vii)       your physical activity levels.
 
Week 4 (1 month), week 24 (6 months) and week 52 (12 months) assessments
You will be mailed questionnaires at 4, 24 and 52 weeks. You will need to complete and return these to the Chief Investigator (Dr Shannon Munteanu) of this study. A pre-paid envelope will be included to facilitate the return of these questionnaires. The questionnaires will measure:


i)          the amount of pain and disability caused by osteoarthritis of your big-toe joint(s);
ii)         your rating as to the amount that your symptoms have changed from the treatment;
iii)         your general health-related quality of life;
iv)        if you needed to use any other treatments to relieve pain in your big-toe joint(s);
v)         your adherence with the treatment(s);
vi)        any adverse events from your treatments;
vii)       your physical activity levels


MRI assessment at week 52: At week 52, you will undergo a follow-up (second) MRI assessment of your painful big toe joint. This will be performed by a qualified radiologist and occur at a radiology clinic called Direct Radiology located at 149-153 Station St, Fairfield).


 
Postal questionnaires at monthly intervals
You will also be mailed questionnaires at monthly intervals. You will need to complete and return these to the Chief Investigator (Dr Shannon Munteanu) of this study. A pre-paid envelope will be included to facilitate the return of these questionnaires. The questionnaires will measure:


i)          if you needed to use any other treatments to relieve pain in your big-toe joint(s);
ii)         your adherence with the treatment(s);
iii)        any adverse events from your treatments;

iv)        any disability caused by osteoarthritis of your big-toe joint(s).

study procedures


Call:

(03) 9479-5258

 Email: m.auhl@latrobe.edu.au