Microembolisation for plantar heel pai

Phase 3

• Conditions: Plantar heel pain; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619001765112
• Lead Sponsor: Barwon Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-12
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in foot pain as assessed by the Foot and Ankle Outcome Score (FAOS).[6 months post intervention]

Secondary Outcome Measures

Name	Time	Method
Change in foot pain as assessed by the Foot and Ankle Outcome Score (FAOS)[One and 12 months post intervention];Change in self-reported physical function as assessed by the Foot and Ankle Outcome Score (FAOS)[One, six and 12 months post intervention];Change in quality of life as assessed by the Foot and Ankle Outcome Score (FAOS)[One, six and 12 months post intervention];Self-reported global assessment of change (7 point scale)[One, six and 12 months post intervention]