None listed
Conditions
Brief summary
Patellofemoral osteoarthritis (PF OA) is a leading cause of pain, disability and health expenditure in Australia, has no cure, and there is little evidence for effective treatments. Pilot data shows that simple contoured shoe inserts (foot orthoses) worn in everyday footwear can reduce pain in older adults with PF OA immediately and after 2 months of wear. This clinical trial will investigate whether contoured shoe inserts are an efficacious longer-term intervention for PF OA. The primary aim is to compare the 3-month efficacy of prefabricated, contoured shoe inserts to flat shoe inserts for reducing the severity of knee pain in people with PF OA. The FOOTPATH trial is a multicentre, randomised, controlled, assessor-blinded superiority trial with two parallel groups and 12-month follow-up. 160 participants aged 50 years and older will be randomly allocated to receive either contoured shoe inserts or flat shoe inserts. Outcomes will be evaluated at 3 and 12 months. Secondary aims will compare the 3- and 12-month effects of contoured inserts and flat inserts on pain, global improvement, function, quality of life, self-efficacy, kinesiophobia, adverse events and use of co-interventions, while cost-effectiveness will be evaluated at 12 months.
Interventions
Participants will receive contoured shoe inserts (foot orthoses) from a commercially available range (Vasyli International, Labrador, Australia). The inserts are manufactured from ethylene-vinyl acetate (EVA) of high, medium and low density, and have an inbuilt arch support and 6 varus wedging. A variety of lengths and shapes are available to fit the shape of different footwear. Study practitioners (Podiatrists, Physiotherapists) will fit contoured inserts to the participants’ shoes, following a
Participants will receive contoured shoe inserts (foot orthoses) from a commercially available range (Vasyli International, Labrador, Australia). The inserts are manufactured from ethylene-vinyl acetate (EVA) of high, medium and low density, and have an inbuilt arch support and 6 varus wedging. A variety of lengths and shapes are available to fit the shape of different footwear. Study practitioners (Podiatrists, Physiotherapists) will fit contoured inserts to the participants’ shoes, following a prescription algorithm that emphasises comfort. Comfort can be enhanced through the addition of wedges to the forefoot, rearfoot or heel, or by gentle heat moulding. Where possible, the inserts will be able to be transferred across their usual footwear. Participants will be given written instructions for using and adapting to the inserts, and will be advised to wear the inserts as much as possible for the duration of the study (12 months). To reflect current clinical practice, and to provide sufficient opportunity to ensure adequate comfort and prescribe additional inserts, participants will attend up to 6 appointments (each approx. 20-30 mins duration) with the study practitioner in their private clinic, in the initial phases of the study. Participants will be provided with up to 4 pairs of contoured inserts, fitted to multiple pairs of commonly worn shoes, in order to maximise wear time. Participants with a high BMI (30 kg/m2) will attend a follow-up appointment 6 months after randomisation to receive new inserts. This will not be necessary for those with a BMI <30 kg/m2, as the pressure-redistributing properties of the contoured inserts are maintained after 12 months. To maximise outcomes of wearing a comfortable, contoured device, participants will receive one pair of sandals from the Vionics range (Vionics International, San Francisco, USA). Participants will be encouraged to wear these during times that they do not normally wear enclosed footwear (e.g. at home).
Sponsors
La Trobe University
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
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria are: (i) age 50 years and over; (ii) predominant symptom anterior or retropatellar knee pain aggravated by at least two PF joint loading activities (e.g. stairs, squatting, rising from sitting); (iii) pain present during these activities on most days of the previous month; (iv) pain severity of at least 3 on an 11-point numerical rating scale (NRS, 0-10) during aggravating activities; (v) duration of symptoms of at least 3 months; (vi) either no morning joint-related stiffness, or morning stiffness that lasts no longer than 30 minutes.
Exclusion criteria
Volunteers will be excluded if they have: (i) knee pain symptoms predominantly from other knee (tibiofemoral joint [TFJ]) structures, hip or lumbar spine; (ii) knee injections or use of shoe inserts within the previous 3 months; (iii) recent commencement of new physiotherapy treatment for PF pain (i.e. new intervention, or modifications to an existing intervention such as therapeutic exercise); (iv) any foot condition precluding the use of shoe inserts; (v) history of lower limb surgery involving major reconstructive procedure (e.g. anterior cruciate ligament reconstruction, osteotomy, arthroplasty); (vi) planned lower limb surgery in the following 12 months; (vii) neurological or systemic arthritis conditions; or (viii) contraindications to x-ray (pregnancy, breastfeeding).
Outcome results
None listed