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Recruiting Not applicable

Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain

NCT06632639 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2024-11-12
Last updated
2024-11-26

Condition(s) studied

Genu Varum

Investigational drug(s) / intervention(s)

Corrective exercise protocolLateral wedged insoles with subtalar strapping

Corrective exercise protocol: The program requires 60 minutes consisting of a ten-minute warm-up, a forty-minute Thera-band exercise, and a ten-minute cool-down. Thera-band exercises are to improve the external rotators, and the extensors and for strengthening the quadriceps and the gluteus. A set consists of 15 reps, each of the exercise methods consisted of three sets.

Lateral wedged insoles with subtalar strapping: A silicon rubber 10 mm lateral wedge has a 10 mm lateral elevation and a 75 mm width, which has an approximately 7.6 inclination. This silicon rubber material is usually used for cosmetic remodeling and has a natural form-fit to the skin. The 75 mm width silicon rubber is scaphoid shaped and it is suitable for attachment to a barefoot of all of the subjects. The rational for using this inclination is that 7.6 is approximately the median between 5 and 10. Patients will be instructed to use the wedge in an appropriate shoe (not high heels or narrow-toed shoes), 1 h a day during the first week. The duration of use gradually will be increased to the minimum of 8 h a day.

Study summary

The purpose of the study is to investigate the effect of lateral wedged insoles with subtalar strapping in genu varum with medial compartment knee pain on:

1. Space between knees (measured by vernier calipers)
2. Degree of genu varum deformity (Femorotibial angle (FTA)) measured on long film weight bearing x-ray)
3. Pain level (Measured by VAS)
4. Hind foot angle (measured by long axial hindfoot alignment view)
5. Functional outcome (measured by the lower extremity function scale)
6. Functional performance (measured by the 6 minute walk test)

Eligibility

Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Patients of both genders aged 20-60. * Patients with medial compartment pain. Pain level of 3 or more on the VAS. * Patients with varus deformity are defined as those Those whose femorotibial angle measures 5-10 degrees of genu varum on long film weight bearing x-ray. * Patients with grade one O.A. on Kellgren-Lawrence classification system or without O.A. * BMI less than 35 * Patients with decompensated hind foot (hind foot varus) Exclusion Criteria: * Patients already wearing custom wedged insoles. * Patients with other inflammatory conditions like rheumatoid arthritis or systematic inflammatory arthritis. * Patients with central or peripheral nervous system disease. * Any previous surgical procedure to the knee joint. * Patients who are unable to walk without assistance (cane or a walker). * Pregnancy * Uncooperative patient types due to mental disorders or others.

Primary outcome measure(s)

  • Distance between knees using vernier calipers — 12 weeks
    To measure the distance between the participants' knees, we have them put both feet together, so that both malleolus bones were together, and measured the space between the tibia and medial condyle using vernier calipers.

Trial sites (1)

FacilityCityRegionStatus
Faculty of physical therapy, Cairo University Giza Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06632639 on ClinicalTrials.gov ↗ ← All trials in Egypt