None listed
Conditions
Brief summary
This study will investigate the immediate biomechanical effects of shoe inserts in those with kneecap arthritis, as well as the feasibility of conducting a larger scale clinical trial. Thirty-two participants will be recruited from the Melbourne community, and will remain blinded to the intervention and study hypotheses for the duration of the study. To investigate the immediate biomechanical effects of shoe inserts in those with kneecap arthritis, a within subject, repeated measures study design will be used. The immediate effects of different shoe inserts on lower limb biomechanics will be obtained using a three-dimensional motion capture system during the baseline appointment. Participants will perform walking and stair-stepping tasks while wearing three different shoe insert conditions applied in a random order: (i) own footwear; (ii) own footwear with contoured shoe inserts; and (iii) own footwear with flat shoe inserts. To determine the feasibility of conducting a larger scale clinical trial, a parallel group randomised trial with two groups and a 6 week follow up will be used. Following the study of the immediate biomechanical effects of the shoe inserts, participants will then be randomly assigned to one of two shoe insert conditions (contoured inserts, flat inserts), which they will take home and wear in their usual footwear for 6 weeks. The feasibility of conducting a larger clinical trial will be assessed via willingness of participants to enrol in the study, the number of participants who qualify for the study, adherence with use the allocated shoe inserts, shoe insert diary completion, frequency and types of adverse effects, participant attrition, and treatment credibility. The Podiatrist who fits the shoe inserts will record the number of additional appointments required, prescription notes, and adverse effects during fitting and follow-up appointments (if required). Measures of pain severity, function, quality of life, and overall improvement will inform calculation of sample sizes for future larger-scale clinical trials.
Interventions
Contoured inserts: Commercially-available, full-length prefabricated foot orthoses (Vasyli Custom Red, Vasyli International, Labrador, Australia) will be inserted into the participants’ shoes. These contoured inserts are made of high density (shore A 75 degrees) ethylene-vinyl acetate (EVA), have an inbuilt arch support, and a 6 degree varus wedge as specified by the manufacturer. A full length piece of Cambrelle [Registered Trademark] (Camtex Fabrics Ltd, United Kingdom) will be applied to the
Contoured inserts: Commercially-available, full-length prefabricated foot orthoses (Vasyli Custom Red, Vasyli International, Labrador, Australia) will be inserted into the participants’ shoes. These contoured inserts are made of high density (shore A 75 degrees) ethylene-vinyl acetate (EVA), have an inbuilt arch support, and a 6 degree varus wedge as specified by the manufacturer. A full length piece of Cambrelle [Registered Trademark] (Camtex Fabrics Ltd, United Kingdom) will be applied to the top of the insert to standardize the appearance of the intervention and control inserts. Participants will attend a single 2.5hr testing appointment at La Trobe University, where a registered Podiatrist with 5 years experience will fit one pair of contoured inserts. Participants will be asked to wear the inserts as much as possible for the study duration (6 weeks), and can transfer the inserts to other footwear. This reflects current clinical practice, and will ensure maximal wear time and potential effects. Participants will be contacted by the Podiatrist 4-7 days after fitting, and offered a follow-up appointment (30min) at La Trobe University to amend any issues with the inserts (e.g. to improve comfort). They will be encouraged to contact the Podiatrist at any time during the follow-up period if they experience any issues with the inserts. Adherence to the intervention will be assessed daily via a paper-based diary. Participants will provide information regarding the number of hours per day and number of days per week they have worn their shoe inserts during the 6 weeks.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Volunteers will be included who have a clinical diagnosis of PF OA, based on NICE guidelines (https://www.nice.org.uk/guidance/cg177). This is to facilitate generalization of findings to clinical practice, without the need for imaging. Inclusion criteria will be based on those used in previous studies of kneecap osteoarthritis : (i) aged 50-75 years; (ii) anterior or retropatellar knee pain aggravated by PFJ-loading activities (e.g. stairs, squatting); (iii) pain during these activities on most days in the past month; and (iv) pain severity at least 30mm on a 100mm visual analogue scale (VAS) during aggravating activities.
Exclusion criteria
(i) Concomitant pain from other knee structures, hip or lumbar spine; (ii) recent treatment for knee pain (e.g. knee injections within the previous 3 months; shoe inserts within the previous 12 months); (iii) any foot condition precluding the use of shoe inserts; (iv) knee or hip arthroplasty/osteotomy; (v) neurological or systemic arthritis conditions; (vi) physical inability, too frail or ill to undertake testing procedures (ascertained via questioning, and if needed clinical examination); (vii) inability to understand written and spoken English.
Outcome results
None listed