MedPath

ltrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for the treatment of plantar fasciitis.

Phase 3
Conditions
Plantar Fasciitis.
Plantar fascial fibromatosis (fasciitis)
M72.2
Registration Number
IRCT20151017024572N24
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
42
Inclusion Criteria

More than three months of heel pain (in medial aspect) which is worst with the first few steps after awakening.
Pain and tenderness elicited by palpation of the medial calcaneal or the proximal plantar fascia.
Visual analog scale (VAS) score greater than or equal to 4.
Sonographic plantar fascia thickness greater than 4 mm with hypoechoic change at insertion point to the calcaneus.

Exclusion Criteria

History of ankle or calcaneal trauma.
Positive Tinel’s sign on the tibial nerve (posterior to medial malleoli).
History of systemic inflammatory or connective tissue disease such as rheumatoid arthritis.
History of lumbar disc herniation with S1 radiculopathy.
History of gout.
Uncontrolled diabetes.
History of heel surgery or injections in the last six months.
Cystic or mass lesion at the site of the painful heel.
History of paresthesia, numbness or peripheral neuropathy.
Coagulation disorder.
Pregnancy.
Allergic reaction to Corticosteroid or Dextrose or Ozone.
Infection at the injection site.
Posterior heel pain.
Initiation of PF treatment within 10 days before intervention such as anti-inflammatory drug therapy, physical therapy.
History of vascular insufficiency causing heel pain.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain. Timepoint: Before intervention, 1 and 8 weeks after intervention. Method of measurement: Visual Analogue Scale Questionnaire.
Secondary Outcome Measures
NameTimeMethod
Foot and Ankle Ability Measure (FAAM). Timepoint: Before intervention, 1 and 8 weeks after intervention. Method of measurement: Foot and Ankle Ability Measure (FAAM) Questionnaire.
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