Comparison of ultrasound guided injection of botulinum toxin at the origin of plantar fasciitis with injection of botulinum toxin by Babcock method in the treatment of plantar fasciitis

Phase 3

Recruiting

• Conditions: plantar fasciitis.; Plantar fascial fibromatosis; M72.2

• Registration Number: IRCT20130523013442N33
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

People aged 30 to 60 years who have been diagnosed with unilateral plantaris fasciitis based on history and clinical examination.
After 3 months from the onset of symptoms and the use of conservative treatments, including rest, anti-inflammatory drugs, physical modalities and exercise therapy, the patient's symptoms have not improved.

Exclusion Criteria

History of previous surgery for plantaris fasciitis.
History of injection for treatment of plantaris fasciitis in the last 3 months.
Bilateral plantaris fasciitis
Presence of systemic inflammatory diseases such as rheumatoid arthritis and seronegative arthritis.
History of vascular insufficiency and neuropathic heel pain
Existence of concomitant diseases in the lower limbs, such as a history of tarsal tunnel syndrome symptoms and positive tinel sign.
Presence of effusion in the ankle, which suggests an intra-articular disease
Old fracture of calcaneal bone.
Presence of retrocalcaneal bursitis, Achilles tendinopathy and ankle osteoarthritis
Any ankle or foot deformity, including flat foot and pes cavus.
Uncontrolled diabetes
BMI more than 33
Radicular low back pain
Presence of local infection or trauma near the injection site
Use of anticoagulants
Presence of diseases that involve the neuromuscular junction, such as myasthenia gravis and Eaton Lambert
Known allergy and sensitivity to botulinum toxin or corticosteroids
Presence of cyst or bone mass in the area of ??the heel
Pregnancy or breastfeeding

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the patient's heel pain. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS).;Assessment of plantar fascia thickness. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Measuring the thickness of the plantar fascia with ultrasonography.;Pain pressure threshold. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Algometer.;Assessment of the patient's performance in daily tasks. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Using the FFI-R questionnaire.