Gastrocnemius Tightness and Foot Pain in Children

Child Development Clinical Trial

Official title:

Is There an Association Between Gastrocnemius Tightness and Foot- and Legpain in Children?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862246
• Other study ID #: 526706
• Status: Recruiting
• Start date: May 9, 2023
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: Tina Wik
• Phone: +4772826521
• Email: tina.stromdal.wik[@]stolav.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

Other:
• Clinical examination
No intervention, only clinical examination

Locations

Country	Name	City	State
Norway	St Olavs hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	National Taiwan Normal University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Silvferskiölds test	Clinical measurement of gastrocnemius tightness	2 years