Gastrocnemius Tightness and Foot Pain in Children

NCT05862246 | Recruiting

• 1 other identifier: 526706
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Development; Gastrocnemius Equinus

Outcome Measures

Primary Outcomes (1)

• Silvferskiölds test

  Clinical measurement of gastrocnemius tightness

  2 years

Study Arms (2)

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

Other: 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

Other: Clinical examination

Interventions

Clinical examination OTHER

No intervention, only clinical examination

Children with pain; Control group children without pain

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children referred to pediatric orthopaedic outpatients clinic from a family doctor

You may qualify if:

• Otherwise healthy children referred to pediatric orthopaedic outpatient clinic with foot and/or leg pain with a normal leg function

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• National Taiwan Normal University: collaborator

Study Sites (1)

St Olavs hospital

Trondheim, Norway

RECRUITING

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Håkon Langvatn

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Wik

CONTACT

+4772826521; tina.stromdal.wik@stolav.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

NO (1)