MRI scans will be performed by a qualified technician at Direct Radiology, after a thorough screening checklist is completed to minimise any risks associated with the scans.
The shoe inserts prescribed in this study are commonly used by podiatrists. You will be supplied with an information brochure that will detail how to adjust to wearing the inserts. The occurrence of serious harmful effects from wearing the shoe inserts is extremely rare. However, you may experience mild discomfort in the feet, legs and even your back during the initial stages (first two weeks) of wearing your inserts. However, this discomfort will resolve. If you do experience some discomfort when adjusting to your inserts, you may want to apply a cold pack (wrapped in a damp towel) on the affected area for 10-15 minutes, 3-4 times per day.
Physical therapy program
The physical therapy exercises are commonly recommended and have been shown to effectively reduce pain in people with big-toe joint osteoarthritis. The occurrence of serious harmful effects from performing the physical therapy is extremely rare. However, you may experience mild discomfort in the big-toe joint(s) during and shortly after (1 day) performing the exercises. If you do experience some discomfort when doing these exercises, you may want to apply an ice pack (wrapped in a damp towel) on the affected area for 10-15 minutes, 3-4 times per day. However, if you experience pain that is disabling, you need to stop the exercise. You can restart the exercise training the following day at a level that does not cause disabling pain.
If any of these effects fail to reduce despite following the advice above, if you develop other unpleasant effects, or if you have any concerns, you are advised to contact the Chief Investigator of this study (Dr Shannon Munteanu, phone 9479 5866 email: firstname.lastname@example.org). Dr Shannon Munteanu will arrange a consultation for you at the Health Sciences Clinic, La Trobe University to advise you on how to deal with the harmful effect(s) and determine the need for further referral, if any.
Three months after completing the study, you will be contacted by the study investigators to identify if any unpleasant events have occurred, and to assist you with any concerns or queries. The study investigators will arrange a consultation for you at the Health Sciences Clinic, La Trobe University to advise you on how to deal with the harmful effect(s) and determine the need for further referral, if any.
Questionnaires to measure your mood and how you cope with pain
During the Initial assessment, you will be asked to complete the following questionnaires - Depression, Anxiety and Stress Scale (DASS-21), Arthritis Self-Efficacy Scale, Short Form-36 (SF-36) questionnaire, and Pain Detect Questionnaire. Some of the questions asked in the questionnaires (particularly the DASS-21 questionnaire), may be associated with certain risks, however the risk of occurrence is low. For example, you may feel anxious or distressed, either because of links with unpleasant experiences or because you are uncertain what the questions mean. Additionally, the questionnaires might unearth some sensitive and/or uncomfortable feelings and memories. It is important to note that there are no right or wrong answers for each of the questionnaires because your response reflects your own experiences. If completion of the questionnaire is too confronting and/or places undue stress on you, you will be given the option of withdrawing from the study. In addition, you will be encouraged to discuss your involvement and emotional response to the survey with your General Practitioner.
Big toe arthritis study
As a study participant, you will receive a thorough diagnosis of the pain in your big-toe joint, a physical therapy program for your big-toe joint pain and one of two types of shoe inserts. We cannot guarantee that these treatments will result in an improvement in your big toe joint pain. Your involvement in this research study will assist health-care practitioners in choosing the best treatment(s) for people affected by big-toe joint pain.
As a participant of this study, you do not have to pay for the x-rays, MRI imaging or treatment you receive, nor will you be required to pay for the postage of the questionnaires. If you attend the initial assessment and are deemed ineligible for the study, there will also be no cost to you. You will need to travel to Direct Radiology (149-153 Station St, Fairfield) for the MRI scans and you will not be re-imbursed for costs associated with this travel.