Patellofemoral joint osteoarthritis: the effect of foot orthoses on pain, function and bone marrow lesions. A pilot study

Phase 2

Active, not recruiting

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

• Registration Number: ACTRN12615000002583
• Lead Sponsor: Professor Kay Crossley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for this study will be the feasibility of a Phase 3 trial. Feasibility will be assessed by evaluating recruitment rate, the number of eligible participants, the willingness of participants to commit to the study protocol, optimal time frames for manufacture and provision of the interventions, adherence to the interventions over the 4 months of the study, the number of adverse events, diary completion, and drop-out rate. [4 months]