Effects of Shock Absorbing Insoles on Knee Pain and Walking in Persons With Knee Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Shock Absorbing Insole (SofSole Athletes Plus)

• Registration Number: NCT02018380
• Lead Sponsor: Winston Salem State University

Brief Summary

Osteoarthritis (OA) is a progressive, chronic disease affecting more than 20 million Americans. There is no known cure for OA and management includes pain control and prevention of functional decline.

Purpose: To investigate the immediate effects of a shock absorbing insole (SAI) placed in the shoe on knee pain, functional mobility and lower extremity biomechanics.

Detailed Description

Sixty adults (age 50+) with knee OA and pain will be recruited. A physician will diagnose the severity of knee OA through radiographs. Participants will be tested in the KBR Human Performance Lab on the campus of Winston Salem State University (WSSU). Participants will complete a demographic form and a survey about their knee pain and function. Participants will be evaluated under two conditions: 1) with SAI placed inside the shoe and 2) shoes alone. There are three walking tasks: 1) walking 25 feet at their usual pace; 2) walking 25 feet at a fast pace; 3) walking six minutes for distance; and a 4) biomechanical gait analysis. After each of the walks, participants will rate the amount of knee pain they experienced. During the biomechanical analysis, participants will walk down a 20 foot walkway while wearing reflective markers. Eight cameras and a force plate embedded in the walkway will measure the amount of body movement and the forces applied to the leg joints during walking.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Study First Submitted: 2009-06-29
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-16
• Last Update Submitted: 2013-12-16
• Study First Posted: 2013-12-23
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 50 years of age or older
• Radiographic evidence of knee OA in the test extremity (K-L grading scale = 1 to 4)
• Knee pain (WOMAC pain subscore of 4 or more and report moderate pain on at least 1 listed activity in the WOMAC) on most days
• Able to speak, write, and understand English
• Able to walk 25 feet without an assistive device
• Must wear a shoe size available in the lab (Women's 6-10 and Men's 8-14)
• Able to attend two sessions of data collection within 14 days

Exclusion Criteria

• Currently wearing some type of foot orthosis (custom or over-the counter)
• Had lower extremity surgery of the test leg in the past 12 months
• Had a total knee replacement on the involved leg
• Had hip and/or ankle OA in the involved leg
• Had a neuromuscular disease disorder which affected their walking ability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shock Absorbing Insoles vs. Athletic shoes	Shock Absorbing Insole (SofSole Athletes Plus)	-

Primary Outcome Measures

Name	Time	Method
Knee pain while walking	Baseline

Secondary Outcome Measures

Name	Time	Method
Ground Reaction Forces	Baseline
Gait speed	Baseline
Knee joint kinetics during stance phase of gait	Baseline

Trial Locations

Locations (1)

Winston Salem State University; 🇺🇸 Winston-Salem, North Carolina, United States