Plantar FascitisNCT07907250
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
A study testing 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 people with Plantar Fascitis and Chronic Heel Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plantar Fascitis, Chronic Heel Pain
- What is being tested?
- 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
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, Chandigarh, 160012
Rajender Kumar, +919216605341, drrajender2010@gmail.com
About this study
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.
Read more
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:
- 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.
- Conditions
- Plantar Fascitis, Chronic Heel Pain
- Being tested
- Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic, Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anestheticProcedure or surgery
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.
Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaestheticProcedure or surgery
After confirming the needle position at the target site by F18 NaF PET/CT, 30 mg corticosteroid and 0.5ml bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic | Active comparator | 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. Receives: Procedure: Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic |
| Group B: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic | Active comparator | 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 Receives: Procedure: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months from baseline
Secondary outcomes (3)
Change in VAS score
Change in the Visual analogue scale (0-10)
Measured: 3 months from baseline
Change in SUVmax
Change in the osteoblastic activity (measured by SUVmax) at the plantar fascia insertion point
Measured: 3 months
Adverse events following Lutetium 177 administration
Any adverse events because of the administartion of lutetium 177 will be assessed
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907250
- Sponsor's protocol ID
- INT/IEC/2026/SPL470
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07907250
- Acronym / sponsor ID
- INT/IEC/2026/SPL470
- Conditions
- Plantar Fascitis, Chronic Heel Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic | Active comparator | Procedure: Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anestheticAfter 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. |
| Group B: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic | Active comparator | Procedure: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaestheticAfter 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anestheticAfter 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. | Procedure or surgery | Group A: Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic |
| Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaestheticAfter confirming the needle position at the target site by F18 NaF PET/CT, 30 mg corticosteroid and 0.5ml bupivacaine will be injected. | Procedure or surgery | Group B: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic |
Primary outcome
Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire)
Time frame: 3 months from baseline
Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire) from baseline to 3 months.
3 secondary outcomes
Change in VAS score
Time frame: 3 months from baseline
Change in SUVmax
Time frame: 3 months
Adverse events following Lutetium 177 administration
Time frame: 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Plantar Fascitis and Chronic Heel Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajender Kumar (+91 9216605341, drrajender2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire) (time frame: 3 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.