Clinical trial NCT06632639: Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
Official title: Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genu Varum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: Genu varum is known as one of the most common lower limb abnormalities. Genu varum is reported to occur 15 to 20% in the whole population. In most cases, this deformity occurs between tillage damage and degeneration in the medial compartment of the knee joint in the long term, because of the imposed imbalanced force on medial and lateral compartments of knees.

Incidence of rachitic genu varum in preschool children: A more recent study from 2016 estimated the incidence of vitamin D deficient rachitic genu varum among preschool children in Egypt, finding it to be 13.1% of all children's orthopaedic diseases at the National Institute of Neuromotor System.

Prevalence of lower limb deformities in primary school students: A 2021 study reported a much lower prevalence of genu varum (0.09%) among primary school students in Egypt. This suggests that the condition may be more prevalent in younger children and decrease in severity with age.

Surgical treatments, such as high tibial osteotomy and total knee arthroplasty (TKA) have been performed. Although this type of surgery has provided successful clinical results, it is often costly for the patients and it forces them to get over complications. In particular, more than 500,000 cases of TKA are annually performed in the US, and approximately three billion dollars are spent on TKA. Alternatives to surgical treatment are required to lighten the patient's burden and the medical costs.

lateral wedged insole significantly reduces the knee varus moment during walking compared to the barefoot condition with no insole. In particular, the strapping insole reduces the varus moment more than the lateral wedged insole alone in moderate OA.

Exercises of correcting genu varum might have positive effects on changes in hip joint angle, Q angle, and knee space distance, and lower limb deformity not by structural causes but by muscular imbalance might be corrected via consistent exercises.

The results of this study could potentially inform the treatment approach for individuals with medial compartment knee pain caused by genu varum. Also provides a non-invasive and cost-effective alternative to managing knee pain, which can improve the quality of life for individuals suffering from this condition. Additionally, this study adds to the body of knowledge on the effectiveness of corrective orthoses in managing musculoskeletal disorders.

Eligibility criteria: 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 outcomes:
measure: Distance between knees using vernier calipers
timeFrame: 12 weeks
Secondary outcomes:
measure: Degree of genu varum deformity measured by long film weight bearing X-Ray
timeFrame: 12 weeks
measure: Pain level measured by the visual analogue scale (VAS)
timeFrame: 12 weeks
measure: Hind foot angle measured by long axial hindfoot alignment view
timeFrame: 12 weeks
measure: Functional outcome measured by lower extremity function scale (LEFS)
timeFrame: 12 weeks
measure: Functional performance measured by the 6 minute walk test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo University
Study officials:
affiliation: Professor, Cairo university
name: Abeer Abdulrahman, PhD
role: STUDY_CHAIR
References: