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

Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for the treatment of plantar fasciitis: A randomized, double-blind, multi-center study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151017024572N24
Enrollment
42
Registered
2020-08-14
Start date
2020-09-20
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciitis. Plantar fascial fibromatosis (fasciitis)

Interventions

Intervention 1: Intervention group one: Corticosteroid, 40 mg Methylprednisolone, one time injection at the site of plantar fascia insertion. Intervention 2: Intervention group two: Ozone (O2-O3), 12

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Before intervention, 1 and 8 weeks after intervention. Method of measurement: Visual Analogue Scale Questionnaire.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Arash Babaei

Iran University of Medical Sciences

arashbabaie@gmail.com+98 21 4128 9221

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026