- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05862246
Gastrocnemius Tightness and Foot Pain in Children
Is There an Association Between Gastrocnemius Tightness and Foot- and Legpain in Children?
Foot and leg pain among otherwise healthy children is a common reason for referral to our pediatric orthopaedics outpatient clinic. The pain is often intermittent and transient, but for some the pain is more dominating and has an impact on the child and families. Children grown and have normal anatomical variations such as in-toeing, out-toeing, hypermobility, flatfeet, knock knees etc. Assessing such normal variants is a major part of pediatric orthopaedic practice, and a common finding is a positive Silvferskiöld test, indicating gastrocnemius tightness. This is when dorsiflexion of the ankle is limited with extended knee, compared to flexed knee. We do not know if this is a more frequent finding among children with foot and leg pain. There is however evidence that adults with painful foot conditions often have gastrocnemius tightness.
This project will investigate for gastrocnemius tightness in otherwise healthy children referred to our pediatric orthopaedic outpatient clinic with foot and leg pain, and compare results with a similar control group of children without pain. The aim is to investigate if there is an association, and how pain and tightness develops over time. The knowledge from this project will enable us to develop new treatment strategies to this patient group, where current evidence based recommendations are few.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tina Wik
- Phone Number: +4772826521
- Email: tina.stromdal.wik@stolav.no
Study Locations
-
-
-
Trondheim, Norway
- Recruiting
- St Olavs hospital
-
Contact:
- Suki Liyanarachi
- Phone Number: +4772821126
- Email: suki.liyanarachi@stolav.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Otherwise healthy children referred to pediatric orthopaedic outpatient clinic with foot and/or leg pain with a normal leg function
Exclusion Criteria:
- Patients with foot conditions, general medical conditions affecting the foot or clinical findings indicating a need for further investigation for a diagnosis. Such as:
Foot deformities (cavo-varus foot, clubfoot) Tarsal coalitions Neuro-orthopedic conditions (CP, MMC) Fracture sequelae Infections and tumour
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with pain
These are children referred with fot and leg pain. Following outcomes will be measured on all included children: Silvferskiölds test Height Weight Gender Age PROM child: Oxford Ankle and Foot Questionnaire for children PROM parent: Oxford Ankle and Foot Questionnaire for parents FPS pain scoring over 1 week |
No intervention, only clinical examination
|
|
Control group children without pain
Following outcomes will be measured on all included children in control group: Silvferskiölds test Height Weight Gender Age |
No intervention, only clinical examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Silvferskiölds test
Time Frame: 2 years
|
Clinical measurement of gastrocnemius tightness
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Håkon Langvatn, St. Olavs hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 526706
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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