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

NCT ID: NCT06632639

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2025-10-31

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.

Conditions

Genu Varum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Corrective exercise protocol + Lateral wedged insoles with subtalar strapping

They will receive the corrective exercise protocol in addition to the lateral wedged insoles with subtalar strapping for 12 weeks.

Group Type: EXPERIMENTAL

Lateral wedged insoles with subtalar strapping

Intervention Type: OTHER

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.

Corrective exercise protocol

Intervention Type: OTHER

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.

Corrective exercise protocol

They will receive the same corrective exercise protocol alone for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Corrective exercise protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ali Abdelmoniem Ali Hassanien

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abeer Abdulrahman, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

Faculty of physical therapy, Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ali Abdelmoniem Ali Hassanien, B.Sc

Role: CONTACT

ali.hassanien1993@gmail.com

01555429409

Abeer Abdulrahman, PhD

Role: CONTACT

Facility Contacts

Ali Abdelmoniem Ali Hassanien, B.Sc

Role: primary

ali.hassanien1993@gmail.com

01555429409

Abeer Abdulrahman, PhD

Role: backup

Other Identifiers

P.T.REC/012/005074

Identifier Type: -

Identifier Source: org_study_id