None listed
Conditions
Brief summary
Patellofemoral osteoarthritis is a common condition that results in pain and functional limitations. Custom foot orthoses are effective at improving pain and function in younger people with patellofemoral pain, and thus may also be of benefit in older people with patellofemoral osteoarthritis. This Phase 2 study aims to investigate the feasibility of a Phase 3 randomised controlled trial evaluating the effect of custom foot orthoses and footwear on pain, lower limb function and bone marrow lesions in patellofemoral osteoarthritis.
Interventions
Intervention: customised EVA (Shore 50) foot orthoses (Orthema Australasia) prescribed according to a predefined protocol, and/or motion control footwear (New Balance 857, Boston, Massachusetts).
Group 1 participants will be asked to wear the custom foot orthoses and prescribed footwear for a period of 4 months.
Group 2 participants will be asked to wear the prescribed footwear only, for a 4 month period.
The interventions are to be worn as often as is practical/possible during the 4 month p
Intervention: customised EVA (Shore 50) foot orthoses (Orthema Australasia) prescribed according to a predefined protocol, and/or motion control footwear (New Balance 857, Boston, Massachusetts). Group 1 participants will be asked to wear the custom foot orthoses and prescribed footwear for a period of 4 months. Group 2 participants will be asked to wear the prescribed footwear only, for a 4 month period. The interventions are to be worn as often as is practical/possible during the 4 month period of the trial, aiming for at least 8 hours per day. Adherence will be documented and encouraged by regular SMS reminders and emails to participants. Participants will be asked to keep a diary of the hours of use of foot orthoses and/or footwear per day, activity levels, and type of footwear worn when not wearing the prescribed footwear. Participants will have review appointments at 1, 2 and 4 months where diary completion will be reviewed, and any issues pertaining to the interventions can be discussed, and if necessary, rectified.
Sponsors
Professor Kay Crossley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) aged >= 40 years; ii) anterior knee pain aggravated by at least two activities that load the patellofemoral joint (e.g. squatting, stair ambulation); iii) pain during these activities present on most days in the past month; iv) pain severity >30mm on a 100mm visual analogue scale during aggravating activities; v) radiographic evidence of patellofemoral joint osteoarthritis (>= OARSI atlas grade 1), or MRI evidence (a definite osteophyte & partial or full thickness cartilage loss. Hunter et al, 2011).
Exclusion criteria
(i) concomitant pain from other knee structures (including TFJ), hip or lumbar spine; (ii) recent treatment for patellofemoral pain (knee injections within the previous 3 months; foot orthoses or physiotherapy within the previous 12 months); (iii) any foot condition precluding the use of foot orthoses; (iv) knee or hip arthroplasty or osteotomy; (v) planned lower limb surgery in the following 2 months; (vi) moderate to severe concomitant tibiofemoral osteoarthritis (Kellgren and Lawrence grade >= 3 on radiograph); (vii) neurological or systemic arthritis conditions; (viii) physical inability to undertake testing procedures; (ix) contraindications to x-ray (e.g. pregnant, breastfeeding); (x) inability to understand written and spoken English.
Outcome results
None listed