Evaluating Acceptance of Lateral Wedge Insoles for Knee Osteoarthritis in Saudi Arabia: A Mixed-Methods Study

Abstract

Background: Knee osteoarthritis (KOA) is a degenerative cartilage condition marked by inflammation and mechanical processes. In Saudi Arabia (SA), one in ten older individuals suffer from it. KOA often leads to pain, functional limitations, reduced daily activities, and diminished quality of life. For those with medial knee osteoarthritis, lateral wedge insoles (LWI) can alleviate knee pain and enhance function. While LWI offers biomechanical and symptomatic benefits, the perspectives of Saudi KOA patients and physiotherapists on its clinical use are not well-understood. In addition, there is limited research on gait modification treatment for other types of KOA, especially regarding facilitators and barriers in the Saudi context. Aims: This study aims to identify the suitability and acceptable use of the gait modification approach for reducing knee pain and enhancing functional ability among KOA patients in Saudi Arabia using a mixed methods approach. Methods & Findings: A sequential exploratory mixed-methods approach was employed for this evidence-based study, following the Medical Research Council's (MRC) Framework for Developing Complex Interventions. The research consisted of a systematic review and qualitative investigations, along with the development and testing of a feasibility study. The first component (Background, chapter 2) assesses the efficacy of various gait modification approaches on knee loading, pain, and function with KOA patients, with evidence from the Saudi healthcare system highlighted. Research goals and questions were set. The second component (Systematic reviews and meta-analyses, chapter 4) identifies the most effective gait modification approaches and their primary clinical outcomes during walking. The analysis revealed that most gait modification methods did not significantly reduce the KAM 1st peak in the short and mid-terms. However, the systematic review indicated that lateral stiffener shoes could reduce the KAM 1st peak in the short term, and re-gait training with toe-out positioning might significantly improve the KAM 2nd peak. Furthermore, in the short term, LWI significantly impacted both the KAM 2nd peak and the knee adduction angular impulse (KAAI). Despite these specific benefits, the overall effectiveness of gait modification in reducing knee loading was limited. Subsequently, the third section (Qualitative – chapter 5) utilised semi structured interviews and focus group discussions to grasp KOA patients' and physiotherapists' views on various gait modification techniques before adapting the LWI approach to the Saudi healthcare setting. This approach aimed to identify key features of gait modification and further understanding of stakeholders' knowledge, attitudes, and challenges in its application for KOA patients. The research indicated that implementing knee braces, canes, footwear and insoles was straightforward for patients and therapists, providing notable benefits and improving daily activities. Drawing from prior research, a feasibility study was designed, outlining the suggested LWI as a gait modification, implementation duration, outcomes, and satisfaction survey. The fourth component (Feasibility - chapter 7) evaluated the acceptability, tolerability, and feasibility of personalised LWI for KOA patients at a Saudi centre. This section implemented LWI as a gait modification, measuring recruitment, retention, adherence rates, the Numerical Rating Pain Scale (NRPS), the Osteoarthritis Index (WOAMC), and conducting satisfaction surveys for both patients and therapists. In the initial session, KOA patients were assigned LWI with baseline records, followed by self-reported outcomes, Then, at the 6th week, clinical outcomes (NRPS & WOAMC) were reassessed, and a survey was collected. Of the 21 KOA participants who consented for the quantitative analysis, 17 completed the final evaluation. The study achieved an 87.5% recruitment rate and an 81% retention rate after six weeks. However, it is important to note that comfort was an issue for some participants, as two withdrew citing insole discomfort. The compliance rate assisting at 5.47 hours/day, indicating a 71% adherence, which was below the targeted value. After six weeks, KOA participants showed significant improvements in the NRPS. A t-test revealed that these improvements were statistically significant (p = 0.007) with a large effect size (Cohen's d = 0.98). Similarly, the WOMAC results also demonstrated statistically significant improvements (p < 0.001) and large effect size (Cohen's d = 1.56). Seventeen KOA patients, who completed a survey, approved the LWI and expressed their satisfaction. They rated their satisfaction with the LWI application's clarity at 5 (extremely satisfied) and their symptoms improved satisfaction with the LWI at (64.7% - very satisfied). In the survey, KOA patients rated LWI as straightforward, well-tolerated and adverse-effect-free. The overall therapists’ satisfaction median was "Very satisfied," highlighting a positive response towards the practical skills enhancement provided by the insole, while the overall median for agreement items was "Agree," indicating a consensus among therapists on the insole's beneficial impact on their treatment routine. Given these results, the suitability of LWI in KOA recovery remains debatable. Conclusion: The LWI was viewed as a viable treatment option for KOA in the Saudi context. Both patients and physiotherapists had shown significant interest in this approach. The results of a six-week intervention highlighted its practical benefits, such as reduced knee pain and improved walking capability. Continuous support and guidance from physiotherapists contributed to high levels of adherence, contributing to maintaining activity levels. While LWI offered a promising option in KOA rehabilitation, its full potential remained unexplored. Factors like the current SA KOA clinical protocol, infrastructure difficulties, therapist expertise and LWI availability needed consideration. In the Saudi context, a follow-up trial was essential after this initial intervention to assess the programme's long-term viability and cost-effectiveness. Furthermore, Although the physiotherapists' satisfaction survey indicated that the LWI programme was debatable, the physiotherapy educators needed to integrate knowledge about assistive gait modification (LWI) into their academic and clinical programmes to enhance evidence-based practice.