Modified SHoes for osteoARthritis of the Knee: the SHARK study

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12613000851763
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-02
• Study Completion: 2015-11-24
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Aged>50;
Knee pain on most days of the last month;
Kellgren & Lawrence Grade 2 or above radiographic changes
Presence of medial osteoarthritis on x-ray (grade 1 medial osteophytes AND grade 1 medial joint space narrowing, as defined by a standard radiographic atlas);
Minimum average knee pain score of 4 on an 11-point numerical rating scale

Exclusion Criteria

Predominant lateral tibiofemoral osteoarthritis on x-ray (lateral osteophytes (joint space narrowing) greater than medial);
Intra-articular corticosteroid injection or knee surgery to either knee within past 3 months;
Systemic arthritic conditions;
History of knee joint replacement or high tibial osteotomy or plan for surgery to either knee in next 6 months;
Other muscular, joint or neurological condition affecting lower limb function;
Current or previous 6 months use of shoe insert, knee or ankle brace or customised shoes prescribed by a health professional;
Unable to walk unaided;
Body mass index> 36 kg/m2 (due to difficulties in biomechanical gait analysis);
Ankle/foot pathology/pain on either side

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessed by 11-point numeric rating scale[ Baseline and 6 months];Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale[ Baseline and 6 months]