Osteoarthritis, KneeNCT03225911
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
A study testing Lateral wedge insole (insole), simple knee sleeve (sleeve) and simple knee sleeve + lateral wedge insole in people with Osteoarthritis, Knee, run by University of Salford.
Trial summary
The focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the short term effect over 6 weeks. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Lateral wedge insole (insole), simple knee sleeve (sleeve) and simple knee sleeve + lateral wedge insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2017to 25 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3 out of 10) because our aim of the study to reduce pain with combined treatment and pain lower than 3 out of 10 score might not allow to compared the pain reduction between the group.
- 2- Definitive medial joint narrowing higher or equal to the lateral side and osteophytes on X-Ray A-P or PA view in weight bearing position if possible.
- 3- Medial joint tenderness either by patient's indication or the clinician under the clinical examination indicating tenderness in the tibiofemoral joint.
- 4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological plain x-ray will be used.
- 5- Being able to walk without assisted devices for 100 meters non-stop because he or she will not be able to complete this study protocol.
Who cannot join
- 1- More pain localized to patellpfemoral or lateral joint than the medial knee side on examination.
- 2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any other realignment operation. 6- Total knee replacement. 7- Any condition contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected intra-articular knee joint space in the previous month.
- 9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher will be excluded because previous study showed that individuals with 33 BMI.
- 11- Lower than 35 years and higher than 85 as this period was identified to highest incidence period (Losina et al., 2013). Although individuals with 86 and higher has high prevalence to the knee OA, exclusion this population was important due to high amount of walking and balance test.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of a Lateral Wedge Insole and Simple Knee Sleeve as a Single and Combined Treatment on Biomechanical and Clinical Outcomes in Individuals With Knee Osteoarthritis (The IN-SLEEVE Study).
The focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the short term effect over 6 weeks. Secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Lateral wedge insole (insole), simple knee sleeve (sleeve), simple knee sleeve + lateral wedge insole
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral wedge insole (insole)Device
The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation.
simple knee sleeve (sleeve)Device
Also called knee support
The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.
simple knee sleeve + lateral wedge insoleDevice
The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation. The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.
| Study group | Role | What they receive |
|---|---|---|
| Insole group | Experimental | This group will be treated via using lateral wedge insole. lateral wedge insole is an insole with higher lateral side than medial side. This insole is inserted in the participant shoes. Receives: Device: Lateral wedge insole (insole) |
| Sleeve group | Experimental | This group will be treated via using simple knee sleeve. Simple knee sleeve is a knee support which has no metal support. This sleeve is wrapped around each participant knee. Receives: Device: simple knee sleeve (sleeve) |
| insole + sleeve group | Experimental | this group will have treated via using the later wedge insole and the sleeve together as combined treatment. lateral wedge insole is an insole with higher lateral side than medial side. This insole is inserted in the participant shoes. Simple knee sleeve is a knee support which has no metal support. This sleeve is wrapped around each participant knee. Receives: Device: simple knee sleeve + lateral wedge insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
External knee adduction moment (EKAM)
External knee adduction moment is a curve which is consider as indirect measurement of the knee loading. Using the gait analysis system will give us this outcome
Measured: 6 weeks
Pain measurment.
10 cm visual analogue scale will be used to measure pain.
Measured: 6 weeks
Muscle co-contraction
Muscle co-contraction can be measured after using Electromyography machine. This outcome gives us indicator to the effect of the treatment on muscle activity and loading.
Measured: 6 weeks
Dynamic balance
The modified star excursion balance test will be used. In this test, the participants balance on maintaining single-leg stance, while reaching with the free limb in anterior and lateral directions in relation to the stance foot as far as they can, then return to double support without losing balance.
Measured: 6 weeks
Secondary outcomes (4)
Joint position sense
Each participant was asked to sit at the edge of a bed. Participants were blindfolded and barefoot to eliminate any other effects on the test results. After receiving instructions for the procedure and performing two practice trials, each participant was asked to extend his/her knee to one of the five randomly selected angles. The participate then will be asked to replicated the angle and the angle will be measure by using the gait lab.
Measured: 6 weeks
Pressure pain threshold
Pressure guage will be used to measure the pain threshold on medial condyle and medial malleolus. Each participant will be asked to lie in side lying on the bed and Algometer's probe will be held perpendicular to the area which will be tested. Pain pressure threshold is defined as the lowest pressure intensity at which the pain felt. Pressure will be applied to the area tested at constant speed 10 kPa/s. each participant will be instructed to say stop when the first sensation of pain due to pressure felt. Each patient will be given 2 trials before starting the tests. Area which will be tested are the medial side of the knee as this considered the most painful area and medial malleolus as reference pain-free area (Wylde, Palmer, Learmonth, \& Dieppe, 2011). Each test will be performed 3 times and the average will be calculated for each site. Pain pressure assessment will be performed at the baseline and after 6 weeks in order to investigate the treatments effect.
Measured: 6 weeks
Physical function tests
3 functional tests will be used to investigate the effect of the treatment 40 meter fast paced walk test, 30 second chair stand test, a stair climb test).
A- 40 meter fast paced test. Each participant will be asked to walk 10 meters' distance for 4 time which will be marked by tap on the floor.
B- 30 second chair stand test:
This test represents the number of counts that each participant can do to stand and sit on a chair in 30 second.
C- 9 step stair climb test:
In this test the time which will be taken by each participant to ascend 9 steps (20cm high) and descend will be measured in second.
Measured: 6 weeks
Physical activity level
Exam the effect of the treatment on the physical activity level using physical activity scale for elderly questionnaire. Physical activity will be measured in this study via using physical activity scale for elderly (PASE). PASE (Appendix 7) is a valid and reliable questionnaire to measure the physical activity level (Martin et al., 1999; Ngai, Cheung, Lam, Chiu, \& Fung, 2012; Washburn \& Ficker, 1999).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start25 Sep 2017 (estimated)
- Primary completion25 Dec 2018 (estimated)
- Study completion25 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Responsible party
- Principal investigator, Omar waslallah althomali, University of Salford
- Investigators
- Richard K jones, Phd, Study director, Salford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225911
- Sponsor's protocol ID
- 12345678
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Lateral Wedge Insole and Simple Knee Sleeve as a Single and Combined Treatment on Biomechanical and Clinical Outcomes in Individuals With Knee Osteoarthritis (The IN-SLEEVE Study).
- ClinicalTrials.gov ID
- NCT03225911
- Acronym / sponsor ID
- 12345678
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Study start
- 25 Sep 2017 (estimated)
- Primary completion
- 25 Dec 2018 (estimated)
- Study completion
- 25 Mar 2019 (estimated)
- First posted
- 21 Jul 2017 (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 focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the short term effect over 6 weeks. Secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insole group | Experimental | Device: Lateral wedge insole (insole)This group will be treated via using lateral wedge insole. lateral wedge insole is an insole with higher lateral side than medial side. This insole is inserted in the participant shoes. |
| Sleeve group | Experimental | Device: simple knee sleeve (sleeve)This group will be treated via using simple knee sleeve. Simple knee sleeve is a knee support which has no metal support. This sleeve is wrapped around each participant knee. |
| insole + sleeve group | Experimental | Device: simple knee sleeve + lateral wedge insolethis group will have treated via using the later wedge insole and the sleeve together as combined treatment. lateral wedge insole is an insole with higher lateral side than medial side. This insole is inserted in the participant shoes. Simple knee sleeve is a knee support which has no metal support. This sleeve is wrapped around each participant knee. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3 out of 10) because our aim of the study to reduce pain with combined treatment and pain lower than 3 out of 10 score might not allow to compared the pain reduction between the group.
- 2- Definitive medial joint narrowing higher or equal to the lateral side and osteophytes on X-Ray A-P or PA view in weight bearing position if possible.
- 3- Medial joint tenderness either by patient's indication or the clinician under the clinical examination indicating tenderness in the tibiofemoral joint.
- 4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological plain x-ray will be used.
- 5- Being able to walk without assisted devices for 100 meters non-stop because he or she will not be able to complete this study protocol.
Key exclusion criteria (4 listed)
- 1- More pain localized to patellpfemoral or lateral joint than the medial knee side on examination.
- 2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any other realignment operation. 6- Total knee replacement. 7- Any condition contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected intra-articular knee joint space in the previous month.
- 9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher will be excluded because previous study showed that individuals with 33 BMI.
- 11- Lower than 35 years and higher than 85 as this period was identified to highest incidence period (Losina et al., 2013). Although individuals with 86 and higher has high prevalence to the knee OA, exclusion this population was important due to high amount of walking and balance test.
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 |
|---|---|---|
| Lateral wedge insole (insole)The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation. | Device | Insole group |
| simple knee sleeve (sleeve)Also: knee supportThe simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment. | Device | Sleeve group |
| simple knee sleeve + lateral wedge insoleThe lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation. The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment. | Device | insole + sleeve group |
Primary outcome
External knee adduction moment (EKAM)
Time frame: 6 weeks
External knee adduction moment is a curve which is consider as indirect measurement of the knee loading. Using the gait analysis system will give us this outcome
Pain measurment.
Time frame: 6 weeks
10 cm visual analogue scale will be used to measure pain.
Muscle co-contraction
Time frame: 6 weeks
Muscle co-contraction can be measured after using Electromyography machine. This outcome gives us indicator to the effect of the treatment on muscle activity and loading.
Dynamic balance
Time frame: 6 weeks
The modified star excursion balance test will be used. In this test, the participants balance on maintaining single-leg stance, while reaching with the free limb in anterior and lateral directions in relation to the stance foot as far as they can, then return to double support without losing balance.
4 secondary outcomes
Joint position sense
Time frame: 6 weeks
Pressure pain threshold
Time frame: 6 weeks
Physical function tests
Time frame: 6 weeks
Physical activity level
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Richard K jones, Phd study director
Salford University
Questions about this trial
What is this clinical trial studying?
A study testing Lateral wedge insole (insole), simple knee sleeve (sleeve) and simple knee sleeve + lateral wedge insole in people with Osteoarthritis, Knee, run by University of Salford.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Althomali, PhD student (07427164565, tt7uu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External knee adduction moment (EKAM) (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 24 Jul 2017.