None listed
Conditions
Brief summary
Plantar heel pain, which is often called Plantar Fasciitis, is a common cause of pain and disability. The condition appears to include the proliferation of blood vessels and nerves in the foot which contribute to the experience of pain. The primary aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature about the foot improves pain, and specifically if adding an anti-inflammatory medication prior to embolisation affects pain differently than embolisation alone. Secondary aims include whether the treatments affect physical function and quality of life. The study is a randomised trial. People are eligible if they have plantar foot pain that has not responded to other forms of traditional management such as medications, podiatry or physiotherapy. Participants will be randomly allocated to one of two groups. Participants in one group will receive embolisation of abnormal vessels about the foot. Participants in the second group group will receive embolisation and an anti-inflammatory medication that is injected in the blood vessels in the foot. All participants will be assessed shortly before the intervention and then 1, 6 and 12 months after the intervention. Assessment includes a variety of questionnaires and physical tests.
Interventions
Embolisation plus NSAID group
Participants in the embolisation plus NSAID group will receive light sedation with midazolam and fentanyl as required and a local anaesthetic injected into their groin. Typical doses of
fentanyl and midazolam are 50mcg and 2mg respectively; both medications are administered intravenously. Femoral artery access will be obtained with a 3 French sheath and a micro-catheter introduced. An angiogram will identify abnormal foot neovasculature which usually appears as a
Embolisation plus NSAID group Participants in the embolisation plus NSAID group will receive light sedation with midazolam and fentanyl as required and a local anaesthetic injected into their groin. Typical doses of fentanyl and midazolam are 50mcg and 2mg respectively; both medications are administered intravenously. Femoral artery access will be obtained with a 3 French sheath and a micro-catheter introduced. An angiogram will identify abnormal foot neovasculature which usually appears as a blush-like enhancement. Immediately prior to embolisation, participants will receive an intra-arterial infusion of Ibuprofen (400mg in 4mL) mixed with 6mL contrast via the micro-catheter. The abnormal vessels will be embolised with a suspension of 0.5 g imipenem and cilastatin sodium (Primaxin; Merck & Co, Whitehouse Station, New Jersey, USA) in 5mL of iodinated contrast agent (prepared by pumping syringes for 10s) by injecting 0.2mL increments until blood flow stagnates. The guide wire will be removed. A dressing will be applied to the puncture site. All procedures will be conducted by a fully qualified interventional radiologist who is trained to perform vascular embolisation. The procedure is expected to take 30-60minutes depending on the number of vessels embolised.
Sponsors
Barwon Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 85 years of age 2. Moderate to severe plantar heel pain 3. Pain resistant to conservative treatment for at least 3 months a. at least one conventional therapy such as analgesia, NSAID, corticosteroid injection, orthotics, physiotherapy (e.g. stretching and/or strengthening exercises) 4. Willing, able and mentally competent to provide informed consent a. able to read and understand the Patient Information and Consent Form which is written in English language
Exclusion criteria
1. Local infection 2. Active malignancy 3. Prior ipsilateral foot or ankle surgery 4. Ipsilateral injection into the foot or ankle in the last 3 months 5. Pregnant or trying to become pregnant during the study period 6. History of allergy to contrast media 7. History of allergy to carbapenem (eg, imipenem, ertapenem or meropenem), or having an immediate or severe hypersensitivity reaction to a penicillin or cephalosporin antibiotic; 8. History of seizures or using valproate 9. History of allergy to NSAIDs 10. Reduced kidney function or failure (chronic or acute) a. Estimated GFR < 30ml/min.1.73m2 b. People on dialysis 11. Body weight greater than 200kg 12. Platelets < 100 x 109/L 13. INR > 1.5 14. Moderate to severe pain in other lower limb joints 15. Previous amputation of ipsilateral toe/s or other part of foot 16. Current or previous ipsilateral foot ulcer 17. Peripheral neuropathy lower limb/s 18. Charcot neuroarthropathy 19. Peripheral vascular disease 20. Rheumatoid arthritis or seronegative arthropathies 21. Ipsilateral foot or ankle pain (excluding plantar heel pain) due to conditions such as achilles tendinopathy or Hallux Abduco Valgus 22. Severe hepatic impairment or heart failure 23. Active or a history of gastrointestinal inflammatory disorder or ulceration, haemorrhage, chronic dyspepsia. 24. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 25. Asthma with known sensitivity to NSAIDs
Outcome results
None listed