Health TrialsbyHealthPanel

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

ConditionGenu Varum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Corrective exercise protocol

    Other intervention

    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

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Corrective exercise protocol + Lateral wedged insoles with subtalar strappingExperimental treatment 2 interventions
Group B: Corrective exercise protocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Distance between knees using vernier calipers

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.

Time frame
12 weeks

Secondary outcomes

1

Degree of genu varum deformity measured by long film weight bearing X-Ray

The femorotibial angle in the frontal plane is the angle formed by the intersection of anatomical axes of the femur and tibia. In normal knee alignment, there is an approximately 5°-7° valgus femorotibial angle.

Time frame
12 weeks
2

Pain level measured by the visual analogue scale (VAS)

The VAS is a uni-dimensional measure of pain intensity.It is a continuous scale that comprises of a horizontal line of 10 cm in length. The scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). A higher score indicates greater pain intensity.

Time frame
12 weeks
3

Hind foot angle measured by long axial hindfoot alignment view

The film cassette is lying on the floor and the subject is standing on the film cassette. The inclination angle of the beam is 45° to the floor.

Time frame
12 weeks
4

Functional outcome measured by lower extremity function scale (LEFS)

The lower extremity function scale (LEFS) is a region specific outcome measure that was designed to assess activity limitations due to musculoskeletal disorders of the lower extremity. LEFS has 20 items each scored on 0-4 Likert scale and the overall score on the scale is produced by summing scores on all items. LEFS score range from 0 to 80 with higher score indicating better functional ability.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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