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

NCT02018380 | Completed Phase 2

• 1 other identifier: 2986-06-0038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee pain while walking

  Baseline

Secondary Outcomes (3)

• Ground Reaction Forces

  Baseline

• Knee joint kinetics during stance phase of gait

  Baseline

• Gait speed

  Baseline

Study Arms (1)

Shock Absorbing Insoles vs. Athletic shoes

EXPERIMENTAL

Other: Shock Absorbing Insole (SofSole Athletes Plus)

Interventions

Shock Absorbing Insole (SofSole Athletes Plus) OTHER

The shock absorbing insole used in this study was the SofSole Athletes Plus, (Implus Inc, Durham, NC), recommended by the manufacturer for repetitive activities such as running and walking. It is readily available in most athletic shoe stores, retailing for under $20.00. The insole is full-length with a curved last made of Implus XP that has a shore A durometer reading of 60 (0 = softest to 100 = hardest).

Also known as: SofSole Athletes Plus

Shock Absorbing Insoles vs. Athletic shoes

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Winston Salem State University: lead
• Wake Forest University Health Sciences: collaborator
• University of North Carolina: collaborator

Study Sites (1)

Winston Salem State University

Winston-Salem, North Carolina, 27110, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Judy L Foxworth, PT, PhD

  Winston Salem State University

  PRINCIPAL INVESTIGATOR

• Darin Padua, ATC, PhD

  Unversity of North Carolina

  STUDY CHAIR

• Stephen Messier, PhD

  Wake Forest University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: December 23, 2013
• Study Start: August 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

US (1)