Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05381558
Collaborator
(none)
20
1
1
17
1.2

Study Details

Study Description

Brief Summary

  • Population: adolescent patients aged from 10 to 16 years

  • Interventions:

  1. Examination under general anaesthesia if the deformity corrected spontaneously

  2. local injection of steroid in sinus tarsi

  3. 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Triamcinolone Injection
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: spasmotic flatfoot patient

Drug: Triamcinolone Injection
local injection in sinus tarsi

Outcome Measures

Primary Outcome Measures

  1. Evaluate the functional outcomes according AOFAS Ankle-hindfoot scale [45days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Pemen Phillip Adely, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05381558
Other Study ID Numbers:
  • Spasmodic faltfoot
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022