Overview
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 :
- Change in pain intensity measured by VAS (0-10).
- Change in osteoblastic activity measured by SUVmax on F-18 NaF PET/CT,
- 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.
Eligibility
Inclusion Criteria:
- Age 18-80 years with chronic plantar fasciitis (\>6 months).
- Failed to conservative therapy.
- Baseline VAS ≥4.
- Focal uptake at plantar fascia insertion on F-18 NaF PET/CT.
Exclusion Criteria:
- Prior radiation therapy to the foot/heel.
- Active infection at the injection site or systemic infection.
- Pregnancy or lactation. (Pregnancy test for women of childbearing potential.)
- Coagulopathy (INR \>1.5 or platelets \<100,000/µL) is not correctable.
- Uncontrolled diabetes or severe peripheral vascular disease affecting wound healing.
- Known allergy to agents would be used for local anaesthesia or to any component of the injection.
