- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381558
Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients
May 15, 2022 updated by: Pemen Phillip Adely, Assiut University
- Population: adolescent patients aged from 10 to 16 years
Interventions:
- Examination under general anaesthesia if the deformity corrected spontaneously
- local injection of steroid in sinus tarsi
- cast in varus for 6 weeks
- Outcomes: primary outcome : Evaluate the clinical and functional outcomes according AOFAS.
- Time: follow up within one and half month, 3 months, 6 months, one year.
Study Overview
Detailed Description
• Does local steroid injection have a role in treatment of spasmodic flat foot in adolescent patients?
One of the most common foot complaints in the juvenile and adolescent age group is the "flatfoot" deformity.
(1) Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid.
(2) The flexible type is a common diagnosis and is one which is usually not problematic and rarely needs treatment.
(3) Rigid flatfoot deformity is less common (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment.
(4) Spasmodic valgus foot is usually associated with resistant pain and deformity.
It shows controversy regarding its incidence, etiology, and treatment.
(5) Spasmodic flatfoot is a rare condition characterized by a rigid and usually painful valgus deformity in the hind foot with peroneal muscles spasms (6,7) It is often caused by inter-tarsal bars or bone anomalies that restrict tarsal joint motion .
(8) Our study aims to evaluate the functional and clinical outcome after local long-acting steroid injection in the sinus tarsi followed by cast in adolescent patients with spasmodic flatfeet without coalition.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: pemen philllip, bachelor
- Phone Number: 01019944221
- Email: pemen.phillip@gmail.com
Study Contact Backup
- Name: peter phillip, bachelor
- Phone Number: 01201949869
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Faculty of Medicine Assiut University
-
Contact:
- pemen phillip, bachelor
- Phone Number: 01019944221
- Email: pemen.phillip@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of the patients from 10 to 16 years
- Flat foot with peroneal muscle spasm
Exclusion Criteria:
Flatfoot uncorrected by manipulation under general anaesthesia
- neuromuscular disorders
- evidence of coalition in CT or MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: spasmotic flatfoot patient
|
local injection in sinus tarsi
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the functional outcomes according AOFAS Ankle-hindfoot scale
Time Frame: 45days
|
45days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- BLOCKEY NJ. Peroneal spastic flat foot. J Bone Joint Surg Br. 1955 May;37-B(2):191-202. doi: 10.1302/0301-620X.37B2.191. No abstract available.
- Jayakumar S, Cowell HR. Rigid flatfoot. Clin Orthop Relat Res. 1977 Jan-Feb;(122):77-84.
- Harris EJ, Vanore JV, Thomas JL, Kravitz SR, Mendelson SA, Mendicino RW, Silvani SH, Gassen SC; Clinical Practice Guideline Pediatric Flatfoot Panel of the American College of Foot and Ankle Surgeons. Diagnosis and treatment of pediatric flatfoot. J Foot Ankle Surg. 2004 Nov-Dec;43(6):341-73. doi: 10.1053/j.jfas.2004.09.013. No abstract available.
- Luhmann SJ, Rich MM, Schoenecker PL. Painful idiopathic rigid flatfoot in children and adolescents. Foot Ankle Int. 2000 Jan;21(1):59-66. doi: 10.1177/107110070002100111.
- HARRIS RI, BEATH T. Etiology of peroneal spastic flat foot. J Bone Joint Surg Br. 1948 Nov;30B(4):624-34. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
May 15, 2022
First Submitted That Met QC Criteria
May 15, 2022
First Posted (Actual)
May 19, 2022
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 15, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Lower Extremity Deformities, Congenital
- Talipes
- Flatfoot
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
Other Study ID Numbers
- Spasmodic faltfoot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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