Clinical Research Directory

F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Summary

Study type: Prospective, randomized, comparative pilot clinical study. Purpose of the study: The goal of this study is to evaluate whether adding low-dose, F-18 sodium fluoride (NaF) PET/CT-guided intralesional Lutetium-177 therapy to corticosteroid and local anaesthetic injection provides better pain relief and functional improvement than PET/CT-guided corticosteroid and local anaesthetic injection alone in patients with chronic plantar fasciitis who have not responded to conservative treatment for more than six months. Participant population: Adults aged 18-80 years with chronic plantar fasciitis lasting more than six months, failure of conservative treatment, a baseline visual analogue scale (VAS) pain score of ≥4, and focal uptake at the plantar fascia insertion on F-18 NaF PET/CT. The study plans to recruit 40 participants, with 20 participants in each group. Primary Outcomes: 1\. Improvement in foot-specific pain and function, assessed by the change in the Manchester-Oxford Foot Questionnaire (MOXFQ) score, and health-related quality of life, assessed by the SF-12 questionnaire, from baseline to three months. Secondary outcomes : 1. Change in pain intensity measured by VAS (0-10). 2. Change in osteoblastic activity measured by SUVmax on F-18 NaF PET/CT, 3. Safety and tolerability at three and six months Comparison groups: Group A (intervention): F-18 NaF PET/CT-guided injection of Lutetium-177 (37-74 MBq; 1-2 mCi) combined with corticosteroid (30 mg) and local anaesthetic. Group B (comparison): F-18 NaF PET/CT-guided injection of corticosteroid (30 mg) and local anaesthetic.

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