An interventional study of Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic and Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic in Plantar Fascitis and Chronic Heel Pain, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Recruiting at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment
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 :
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 298 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After confirming the needle position at the target site by F18 NaF PET/CT, the pre-measured ¹⁷⁷Lu dose (1-2 mCi of 177Lu, 30 mg corticosteroid and 0.5ml bupivacaine) will be injected slowly into the peri-insertional region of the plantar fascia, followed by flushing the tract with 0.9% NaCl solution. The injection volume will be kept minimal (0.2-1.0 mL) to ensure precise localisation without unwanted spread.
Procedure: Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic
After confirming the needle position at the target site by F18 NaF PET/CT, the pre-measured corticosteroid dose(30mg) combined with local anaesthetic (0.5ml of 0.25% bupivacaine) will be injected slowly into the peri-insertional region of the plantar fascia. The injection volume
Procedure: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic
After confirming the needle position at the target site by F18 NaF PET/CT, 1-2 mCi of Lutetium-177, 30 mg corticosteroid and 0.5ml bupivacaine will be injected.
After confirming the needle position at the target site by F18 NaF PET/CT, 30 mg corticosteroid and 0.5ml bupivacaine will be injected.
Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire)
Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire) from baseline to 3 months.
Time frame: 3 months from baseline
Change in VAS score
Change in the Visual analogue scale (0-10)
Time frame: 3 months from baseline
Change in SUVmax
Change in the osteoblastic activity (measured by SUVmax) at the plantar fascia insertion point
Time frame: 3 months
Adverse events following Lutetium 177 administration
Any adverse events because of the administartion of lutetium 177 will be assessed
Time frame: 3 and 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 17 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Post Graduate Institute of Medical Education and Research, Chandigarh →