Clinical course of patients with plantar heel pain excluded from the FIX-Heel trial

BACKGROUND: Individuals with plantar heel pain (PHP) are often excluded from randomised clinical trials (RCTs) despite having care-seeking behaviour and symptoms consistent with PHP. This study aimed to describe their clinical course over 12 months after not being included in the FIX-Heel Trial.

METHODS: We conducted a prospective cohort study of individuals with PHP who did not meet one or more of the inclusion criteria: 1) pain on palpation at the medial calcaneal tubercle, 2) plantar fascia thickness > 4.0 mm, or 3) pain > 30 mm on a 100-mm visual analogue scale. Individuals completed the Foot Health Status Questionnaire (FHSQ) and care-seeking behaviour at baseline and after 4, 12, 26, and 52 weeks.

RESULTS: We included 28 individuals who were primarily not included in the trial due to their plantar fascia thickness (86%). Significant improvements were observed in FHSQ Pain and Function scores at 12 weeks compared to baseline (mean difference 9.0 (95%CI: 1.5;16.5, P = 0.019) and 7.7 (95%CI: 0.3;15.2, P = 0.043), respectively), with continued improvement at 26 and 52 weeks. Less than half received treatment at any time point.

CONCLUSION: Despite limited care, individuals not included in an RCT experienced clinically meaningful long-term improvement. These findings shed light on the clinical course of individuals excluded from trials.