The effectiveness of customised 3D-printed insoles on perceived pain, comfort, and completion time among frequent Park Runners: Study protocol for a pragmatic randomised controlled trial (The ZOLES RCT).

BACKGROUND: Running, a popular recreational activity, often leads to the experience of pain and discomfort among participants impacting performance and participation longevity. The ZOLES trial evaluates customised 3D-printed insoles for reducing pain in frequent parkrunners aged 35 and over. An innovative process of foot-scanning and responses to questions relating to size, pain, discomfort, and previous medical conditions are combined leading to the production of personalised 3D-printed orthotics. METHODS: The ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority trial involving 200 recreational runners, randomised to receive either customised 3D-printed insoles (ZOLES) or to a "do-as-usual" control group. The study follows a robust protocol, ensuring adherence to established guidelines for clinical trials, and is based at St Mary's University, Twickenham, London. The primary outcome is change in running-related pain over a 10-week period, assessed using an 11-point Numeric Rating Scale. Secondary outcomes include overall pain and discomfort, running-related comfort, 5k-completion time, time-loss due to injuries, running exposure, and adherence to the intervention. A balanced-block randomisation process is stratified by sex and parkrun location, and an intention-to-treat analyses will be employed on all outcomes in the primary trial report. The trial includes a 52-week post-market surveillance to assess long-term effects of the customised insoles. DISCUSSION: The ZOLES trial aims to provide insights into real-world applicability and effectiveness of customised 3D-printed insoles in reducing running-related pain and enhancing overall running experience. Despite the limitation of a subjective primary outcome measure without participant blinding, the methodological rigor, including external outcome assessment and data handling, we anticipate results that are academically credible and applicable in real-world settings The results of this trial may have important implications for runners, clinicians, and the sports footwear industry, as evidence for the use of individualised insoles to improve running experience and prevention of pain may become evident. TRIAL REGISTRATION: The trial was pre-registered at ClinicalTrials.gov with the trial identifier NCT06034210 on September 4, 2023, and publicly posted on September 13, 2023 (https://clinicaltrials.gov/study/NCT06034210). PROTOCOL VERSION: Version 1, September 27, 2023.

Validity of an inertial measurement unit for the assessment of range and quality of movement during head and thoracic spine movements.

BACKGROUND: Patients with spinal pain often exhibit movement limitations and altered motor control, which can be challenging to measure accurately in clinical practice. Inertial measurement sensors present a promising new opportunity to develop valid, low-cost, and easy-to-use methods for assessing and monitoring spinal motion in a clinical setting. AIM: This study aimed to investigate the agreement of an inertial sensor and a 3D camera system for assessing the range of motion (ROM) and quality of movement (QOM) in head and trunk single-plane movements. METHODS: Thirty-three healthy, pain-free volunteers were included. Each participant performed movements of the head (cervical flexion, extension, and lateral flexion) and trunk (trunk flexion, extension, rotation, and lateral flexion), which were simultaneously recorded by a 3D camera system and an inertial measurement unit (MOTI, Aalborg, Denmark). Agreement and consistency were analyzed for ROM and QOM by determining intraclass correlation coefficients (ICC), mean bias, and with Bland-Altman plots. RESULTS: The agreement between systems was excellent for all movements (ICC between 0.91 and 1.00) for ROM and good to excellent for the QOM (ICC between 0.84 and 0.95). The mean bias for all movements (0.1-0.8°) was below the minimum acceptable difference between devices. The Bland-Altman plot indicated that MOTI systematically measured a slightly greater ROM and QOM than the 3D camera system for all neck and trunk movements. CONCLUSION: This study showed that MOTI is a feasible and potentially applicable option to assess ROM and QOM for head and trunk movements in experimental and clinical settings.

Quality of life in adolescents with longstanding non-traumatic knee pain: An analysis of 316 adolescents with Patellofemoral Pain and Osgood-Schlatter Disease.

OBJECTIVES: To describe the Quality of Life (QoL) among adolescents with Patellofemoral Pain (PFP) and Osgood-Schlatter Disease (OSD) and investigate characteristics associated with QoL. STUDY DESIGN: Cross-sectional. PARTICIPANTS: 316 adolescents with PFP or OSD. MAIN OUTCOME MEASURES: QoL subscale of The Knee injury and Osteoarthritis Outcome Score (KOOS) and the EuroQol 5-dimensions (EQ-5D). RESULTS: The KOOS-QoL was 51 ± 18, and the total index score for the EQ5D was 0.67 ± 0.21. KOOS-QoL subscale showed that 60% reported being aware of their knee problems daily or constantly, 38% reported severe to extreme lack of confidence in their knees, 28% reported severe to extreme difficulty with their knees, and 20% reported severely or totally modifying their lifestyle to avoid potentially damaging activities to their knee. EQ-5D showed that 79% experienced problems with everyday activities, 48% reported mobility problems, 17% felt worried, sad, or unhappy, and 7% reported problems looking after themselves. CONCLUSIONS: Many adolescents with longstanding non-traumatic knee pain experience low QoL. More than half were aware of their knee problems at least daily, one in three reported a severe lack of confidence in their knee, and one in six felt worried, sad, or unhappy.

What is known and what is still unknown within chronic musculoskeletal pain? A systematic evidence and gap map.

ABSTRACT: Evidence and gap maps (EGMs) can be used to identify gaps within specific research areas and help guide future research agendas and directions. Currently, there are no EGMs within the broad domain of chronic musculoskeletal (MSK) pain in adults. The aim of this study was to create a contemporary EGM of interventions and outcomes used for research investigating chronic MSK pain. This EGM was based on systematic reviews of interventions published in scientific journals within the past 20 years. Embase, PubMed, the Cochrane Library, and PsycINFO were used to retrieve studies for inclusion. The quality of the included reviews was assessed using AMSTAR-II. Interventions were categorised as either physical, psychological, pharmacological, education/advice, interdisciplinary, or others. Outcomes were categorised using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations. Of 4299 systematic reviews, 457 were included. Of these, 50% were rated critically low quality, 25% low quality, 10% moderate quality, and 15% rated high quality. Physical interventions (eg, exercise therapy) and education were the most common interventions reported in 80% and 20% of the studies, respectively. Pain (97%) and physical functioning (87%) were the most reported outcomes in the systematic reviews. Few systematic reviews used interdisciplinary interventions (3%) and economic-related outcomes (2%). This contemporary EGM revealed a low proportion of high-quality evidence within chronic MSK pain. This EGM clearly outlines the lack of high-quality research and the need for increased focus on interventions encompassing the entire biopsychosocial perspective.