Genu VarumNCT06632639
Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
A study testing Corrective exercise protocol and Lateral wedged insoles with subtalar strapping in people with Genu Varum, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Genu Varum
- What is being tested?
- Corrective exercise protocol and Lateral wedged insoles with subtalar strapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abeer Abdulrahman, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy, Cairo University
Giza
Ali Abdelmoniem Ali Hassanien, B.Sc, 01555429409, ali.hassanien1993@gmail.com
Abeer Abdulrahman, PhD
About this study
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:
- Space between knees (measured by vernier calipers)
- Degree of genu varum deformity (Femorotibial angle (FTA)) measured on long film weight bearing x-ray)
- Pain level (Measured by VAS)
- Hind foot angle (measured by long axial hindfoot alignment view)
- Functional outcome (measured by the lower extremity function scale)
- Functional performance (measured by the 6 minute walk test)
Read the 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
- Being tested
- Corrective exercise protocol, Lateral wedged insoles with subtalar strapping
- Medical subject headings
- Genu Varum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrective exercise protocolOther
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 strappingOther
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 group | Role | What they receive |
|---|---|---|
| Corrective exercise protocol + Lateral wedged insoles with subtalar strapping | Experimental | They will receive the corrective exercise protocol in addition to the lateral wedged insoles with subtalar strapping for 12 weeks. Receives: Other: Corrective exercise protocol; Other: Lateral wedged insoles with subtalar strapping |
| Corrective exercise protocol | Active comparator | They will receive the same corrective exercise protocol alone for 12 weeks. Receives: Other: Corrective exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Functional performance measured by the 6 minute walk test
The patients will walk as far a distance as possible within 6 minutes. They will be instructed to walk as fast as possible, but running or jogging will not be allowed. Standardized encouragement and updates on the remaining time for the 6MWT will be provided at each minute mark. When the patient turns around a cone (set 30 meters away), it will be marked on a worksheet. After 6 minutes, the patients will be told to stop immediately, and a small piece of tape will be placed just in front of their shoes. The additional distance covered (in the final 30-meter stretch) will be measured to the nearest centimeter. Finally, the total distance walked by each patient in 6 minutes will be calculated and recorded. Patients will be permitted to rest by standing or leaning against the wall during the test trial, but the timer will continue to run.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start12 Nov 2024
- Primary completion12 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu VarumStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abdelmoniem Ali Hassanien, Cairo University
- Investigators
- Abeer Abdulrahman, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632639
- Sponsor's protocol ID
- P.T.REC/012/005074
- Status last verified
- Nov 2024
- First submitted
- 7 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
- ClinicalTrials.gov ID
- NCT06632639
- Acronym / sponsor ID
- P.T.REC/012/005074
- Conditions
- Genu Varum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Space between knees (measured by vernier calipers)
- Degree of genu varum deformity (Femorotibial angle (FTA)) measured on long film weight bearing x-ray)
- Pain level (Measured by VAS)
- Hind foot angle (measured by long axial hindfoot alignment view)
- Functional outcome (measured by the lower extremity function scale)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corrective exercise protocol + Lateral wedged insoles with subtalar strapping | Experimental | Other: Corrective exercise protocol, Other: Lateral wedged insoles with subtalar strappingThey will receive the corrective exercise protocol in addition to the lateral wedged insoles with subtalar strapping for 12 weeks. |
| Corrective exercise protocol | Active comparator | Other: Corrective exercise protocolThey will receive the same corrective exercise protocol alone for 12 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrective exercise protocolThe 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. | Other | Corrective exercise protocol, Corrective exercise protocol + Lateral wedged insoles with subtalar strapping |
| Lateral wedged insoles with subtalar strappingA 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. | Other | Corrective exercise protocol + Lateral wedged insoles with subtalar strapping |
Primary outcome
Distance between knees using vernier calipers
Time frame: 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.
5 secondary outcomes
Degree of genu varum deformity measured by long film weight bearing X-Ray
Time frame: 12 weeks
Pain level measured by the visual analogue scale (VAS)
Time frame: 12 weeks
Hind foot angle measured by long axial hindfoot alignment view
Time frame: 12 weeks
Functional outcome measured by lower extremity function scale (LEFS)
Time frame: 12 weeks
Functional performance measured by the 6 minute walk test
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abeer Abdulrahman, PhD contact
Abeer Abdulrahman, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corrective exercise protocol and Lateral wedged insoles with subtalar strapping in people with Genu Varum, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Abdelmoniem Ali Hassanien, B.Sc (01555429409, ali.hassanien1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between knees using vernier calipers (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.