The effects of shoe inserts on lower limb biomechanics in kneecap arthritis: a pilot study

Not Applicable

Completed

• Conditions: Patellofemoral osteoarthritis; Musculoskeletal - Osteoarthritis; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12616001287426
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-13
• Study Completion: 2016-10-12
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee biomechanics:<br>Kinematic data will be acquired using skin-based markers and a three-dimensional motion capture system (Vicon), while ground-embedded force plates will capture ground reaction force data simultaneously. Participants will perform level overground walking and stair ascent/descent under three conditions (random order): (i) shoes alone; (ii) contoured inserts; and (iii) flat inserts. Knee kinematics and joint torques will be calculated using standard procedures.[Immediate effects (baseline)];Feasibility:<br>Feasibility will be assessed by evaluating willingness of participants to enrol; number of eligible participants; recruitment rate; adherence with allocated shoe insert and log-book completion; adverse effects; and drop-out rate. 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. [Baseline through to 6 weeks]