Clinical trial NCT03225911: Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Salford
Sponsor class: OTHER
Collaborators: name: Northern Care Alliance NHS Foundation Trust
First posted: 2017-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. Secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: External knee adduction moment (EKAM)
timeFrame: 6 weeks
measure: Pain measurment.
timeFrame: 6 weeks
measure: Muscle co-contraction
timeFrame: 6 weeks
measure: Dynamic balance
timeFrame: 6 weeks
Secondary outcomes:
measure: Joint position sense
timeFrame: 6 weeks
measure: Pressure pain threshold
timeFrame: 6 weeks
measure: Physical function tests
timeFrame: 6 weeks
measure: Physical activity level
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Salford University
name: Richard K jones, Phd
role: STUDY_DIRECTOR
References: