Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients
Primary Purpose
Flatfoot
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Flatfoot
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
spasmotic flatfoot patient
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the functional outcomes according AOFAS Ankle-hindfoot scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381558
Brief Title
Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients
Official Title
Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
spasmotic flatfoot patient
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Injection
Intervention Description
local injection in sinus tarsi
Primary Outcome Measure Information:
Title
Evaluate the functional outcomes according AOFAS Ankle-hindfoot scale
Time Frame
45days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
pemen philllip, bachelor
Phone
01019944221
Email
pemen.phillip@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
peter phillip, bachelor
Phone
01201949869
Facility Information:
Facility Name
Faculty of Medicine Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pemen phillip, bachelor
Phone
01019944221
Email
pemen.phillip@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14381462
Citation
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.
Results Reference
background
PubMed Identifier
837623
Citation
Jayakumar S, Cowell HR. Rigid flatfoot. Clin Orthop Relat Res. 1977 Jan-Feb;(122):77-84.
Results Reference
background
PubMed Identifier
15605048
Citation
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.
Results Reference
background
PubMed Identifier
10710264
Citation
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.
Results Reference
background
PubMed Identifier
18894612
Citation
HARRIS RI, BEATH T. Etiology of peroneal spastic flat foot. J Bone Joint Surg Br. 1948 Nov;30B(4):624-34. No abstract available.
Results Reference
background
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Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients
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