There is a Lack of Clinical Homogeneity in Lower Limb Tendinopathy Trials: A Scoping Review.

OBJECTIVE: It is unclear if clinical trials of treatments for lower limb tendinopathies include clinically homogeneous participant populations (an assumption for pooling in meta-analyses). We assessed the recruitment setting and participant characteristics used in randomized controlled trials (RCTs) that were investigating any treatment for lower limb tendinopathies. DESIGN: Scoping review. METHODS: We conducted a systematic literature search in the PubMed, Embase, Cochrane CENTRAL, and Web of Science databases. All RCTs that were investigating treatments for lower limb tendinopathies in an adult population (≥18 years) were eligible for inclusion. At least two authors conducted independent screening and selection of full-text papers, and extracted data from included studies. RESULTS: Of 18,341 records, 342 RCTs (21,897 participants) were eligible for inclusion and data extraction. The most common diagnoses were plantar fasciopathy (n=195, 57%), Achilles tendinopathy (n=82, 24%), and patellar tendinopathy (n=41, 12%). Secondary care (n=144, 42%) was the most reported recruitment setting, followed by an open setting (n=44, 13%). In 93 (27%) RCTs, the recruitment setting was not described. We found high heterogeneity in participant characteristics (e.g., symptom duration, age, body mass index, and the Victorian Institute of Sport Assessment (VISA) questionnaire score) within and between recruitment settings. CONCLUSION: Our results question whether clinical homogeneity can be adequately assumed in clinical trials of lower limb tendinopathies due to the lack of clear reporting of the recruitment setting and the variability within and between recruitment settings of key participant characteristics. These findings threaten assumptions for meta-analyses in lower limb tendinopathies.