None listed
Conditions
Brief summary
The overall aim of this research is to compare the effects of using special contoured insoles compared to flat insoles in people who suffer painful osteoarthritis (OA) in their big toe joint. To test this, participants who have big toe OA and are eligible to take part in the study, will be allocated into two different insole groups via a random process. All participants will see a podiatrist who will provide one pair of insoles (either flat or contoured depending on which group they are in), which they will be instructed to wear at all times when wearing shoes for the following 12 weeks.
Interventions
This randomised controlled trial (RCT) involves an intervention group and a control group. Participants in both groups will have two visits with a study podiatrist in weeks 1 and 3, booked following completion of the baseline questionnaire by a study researcher. The initial consultation will be 30 minutes and the follow-up visit will be 15-minute 2 weeks later.
The intervention group will receive foot orthoses, for both feet, protocolised (whilst allowing some individual variation) to ensure co
This randomised controlled trial (RCT) involves an intervention group and a control group. Participants in both groups will have two visits with a study podiatrist in weeks 1 and 3, booked following completion of the baseline questionnaire by a study researcher. The initial consultation will be 30 minutes and the follow-up visit will be 15-minute 2 weeks later. The intervention group will receive foot orthoses, for both feet, protocolised (whilst allowing some individual variation) to ensure consistency based on findings from our international survey (Paterson et al 2018, Osteoarthritis & Cartilage). Specifically, a blue (medium-density) FormthoticTM prefabricated foot orthotic, moulded from 140kg/m3 single-density, closed-cell polyethylene foam, (Foot Science International, Christchurch, New Zealand) will be prescribed, and modified using a first MTP joint cut out for joint rotation. If the participant does not have available first MTP joint range of motion (i.e. zero degrees), or if the cut out elicits immediate pain on walking, then a first ray extension will be used instead. Participants with a Foot Posture Index (FPI) score >7 will also have a full length 4° varus wedge (Formthotics, Foot Science International, Christchurch, New Zealand) adhered to the plantar surface of the orthoses. Orthoses will be trimmed (if needed) and fitted into participant’s footwear at the initial visit. At this time, participants will be advised to initially commence wearing the orthoses for 1 hour on the first day and to increase use by an additional hour each day, until they are wearing them at all times when shod for 12 weeks. The orthoses will be reviewed at the follow up visit, and additional orthoses modifications to address comfort or adverse events may be provided (and documented), if necessary. Adherence to the intervention will be monitored via self-report of insole and shoe wear in a log book once per month for a one-week period, and by using an 11-point NRS for overall adherence at the 12-week follow-up time point. The control group conditions are described below under 'Comparator / control treatment' The alternate insole type will be concealed from participants for the duration of the trial.
Sponsors
University of Melbourne
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
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) aged 45 years or older, ii) report first MTP joint pain on most days of the month for at least 12 weeks, iii) report a minimum pain score of 3 on an 11-point numerical rating scale during walking over the previous week, iv) evidence of radiographic osteoarthritis (OA) (a score of 2 or more for osteophytes or joint space narrowing according to a radiographic atlas), due to a lack of accepted clinical diagnostic criteria for first MTP joint OA, and v) report either no morning joint-related stiffness in the 1st MTP joint, or morning stiffness that lasts no longer than 30 minutes.
Exclusion criteria
i) previous foot surgery or planned surgery on the affected side in the next 12 weeks; ii) current use of foot orthoses or ankle braces, iii) current primary use of high heels, thongs or other shoes that would restrict ability to wear orthoses, iv) had any foot injections on the affected side in the past 6 months or planned injections in next 12 weeks, v) self-report any other current muscular, joint or neurological condition affecting lower limb function, vi) self-report any systemic or inflammatory joint disease (eg rheumatoid arthritis), vii) grade 3 or 4 hallux valgus on the affected side, viii) current or planned use of a gait aid in the next 12 weeks, ix) inability to understand written/spoken English, x) unable to commit to study requirements (eg wearing insoles, attending appointments, completing outcomes).
Outcome results
None listed