Laterally Wedged Insoles for Patients With Knee Osteoarthritis

The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01763515

Enrollment

120

Registered

2013-01-09

Start date

2012-10-31

Completion date

2013-10-31

Last updated

2013-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Joint Diseases, Arthritis, Osteoarthritis

Brief summary

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

Detailed description

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. Because of the high incidence of knee osteoarthritis in the elderly and the seriousness of drug effects in this age group and lack of controlled study in our country regarding the possible benefits or lack of benefit of laterally wedged insoles in patients with knee osteoarthritis and also due to strike, and results of mixed in other studies, this study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

Interventions

PROCEDURELaterally wedged insoles

Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Symptomatic medial femorotibial knee OA, * Daily knee pain for at least 1 month in the last 3 months, * Radiographic evidence of medial femorotibial knee OA, * Normal erythrocyte sedimentation rate.

Exclusion criteria

* Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography, * Knee joint lavage in past 3 months, * Intra-articular corticosteroid injection during the past 3 months, * Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in knee pain severity after 2 months.	Up to 2 months	The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.

Secondary

Measure	Time frame	Description
Change from baseline in knee's functional degree after 2 months.	Up to 2 months.	Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026