OsteoarthritisPhase 2NCT02018380
Effects of Shock Absorbing Insoles on Knee Pain and Walking in Persons With Knee Osteoarthritis
A Phase 2 study testing Shock Absorbing Insole (SofSole Athletes Plus) in people with Osteoarthritis, run by Winston Salem State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Shock Absorbing Insole (SofSole Athletes Plus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2008
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Winston Salem State University
Winston-Salem, North Carolina, 27110
About this study
Official title: Immediate Effects of Shock Absorbing Insoles on Knee Pain, Functional Mobility, and Lower Extremity Biomechanical Characteristics in Persons With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Shock Absorbing Insole (SofSole Athletes Plus)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Absorbing Insole (SofSole Athletes Plus)Other
Also called SofSole Athletes Plus
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).
| Study group | Role | What they receive |
|---|---|---|
| Shock Absorbing Insoles vs. Athletic shoes | Experimental | Not described Receives: Other: Shock Absorbing Insole (SofSole Athletes Plus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain while walking
Measured: Baseline
Secondary outcomes (3)
Ground Reaction Forces
Measured: Baseline
Knee joint kinetics during stance phase of gait
Measured: Baseline
Gait speed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startAug 2006
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Salem State University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, University of North Carolina
- Responsible party
- Principal investigator, Judy L. Foxworth, PT, PhD, OCS, Winston Salem State University
- Investigators
- Judy L Foxworth, PT, PhD, Principal investigator, Winston Salem State UniversityDarin Padua, ATC, PhD, Study chair, Unversity of North CarolinaStephen Messier, PhD, Study director, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018380
- Sponsor's protocol ID
- 2986-06-0038
- Status last verified
- Dec 2013
- First submitted
- 29 Jun 2009
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Shock Absorbing Insoles on Knee Pain, Functional Mobility, and Lower Extremity Biomechanical Characteristics in Persons With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02018380
- Acronym / sponsor ID
- 2986-06-0038
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Winston Salem State UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, University of North Carolina
- Study start
- Aug 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock Absorbing Insoles vs. Athletic shoes | Experimental | Other: Shock Absorbing Insole (SofSole Athletes Plus) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Shock Absorbing Insole (SofSole Athletes Plus)Also: SofSole Athletes PlusThe 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). | Other | Shock Absorbing Insoles vs. Athletic shoes |
Primary outcome
Knee pain while walking
Time frame: Baseline
3 secondary outcomes
Ground Reaction Forces
Time frame: Baseline
Knee joint kinetics during stance phase of gait
Time frame: Baseline
Gait speed
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Judy L Foxworth, PT, PhD principal investigator
Winston Salem State University
Darin Padua, ATC, PhD study chair
Unversity of North Carolina
Stephen Messier, PhD study director
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shock Absorbing Insole (SofSole Athletes Plus) in people with Osteoarthritis, run by Winston Salem State University at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain while walking (time frame: Baseline). 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 23 Dec 2013.