Shoe inserts for kneecap arthritis: The FOOTPATH Study

Not Applicable

Completed

• Conditions: Osteoarthritis of the patellofemoral joint; Musculoskeletal - Osteoarthritis; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12617000385347
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-15
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Worst knee pain severity during a self-nominated aggravating activity in the previous week. Participants will nominate one of three everyday activities that they experience the greatest pain severity (rising from sitting, squatting, stair ambulation). Pain severity will be measured on a 100mm VAS (terminal descriptors 0=no pain, 100=worst pain possible).[Baseline, 6 weeks, 3 months (primary timepoint), 12 months]