Shoes for self-managing chronic hip Pain: the SCHIPP randomized clinical trial protocol

Abstract

Abstract Background Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options. Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate ‘stable supportive’ shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled trial (RCT) aims to determine if stable supportive footwear reduces hip pain during walking compared to flat flexible footwear in people with chronic hip pain consistent with OA. Methods This trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures. Discussion This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.