Clinical Study #1

In this randomised controlled efficacy study, Gary Merrel M.D. Laura Miller R.V.T. and Marisssa Campbell examined the efficacy (effectiveness) of HappyFeet Insoles on the Circulatory System and Lower Extremity Health

The Clinical Study Was Prefaced As Follows:

Venous Stasis is a common disorder and places the general population at risk for deep vein thrombosis, lower extremity edema, cellulitis, thrombophlebitis and many other complications of compromised circulation.

Because of the vast number of people affected by this disorder and the potential benefits of HappyFeet® insoles on the circulatory system, the primary investigators, including Sona Imaging Solutions, Inc., and 1910 Consulting, were interested in determining the efficacy of HappyFeet® insole use on the circulatory system and lower extremity health. While there have been efficacy studies on the effects on shoe insoles in regards to pain perception, there is no previous data on an insole that can increase circulation, reduce pain and overall fatigue.1-5

Objectives & Control Measures Adopted

OBJECTIVE:
To determine the efficacy of HappyFeet® insoles in increasing circulation in the lower extremities while decreasing daily pain and fatigue.

DESIGN, SETTINGS AND PARTICIPANTS:
A double-blind, placebo-controlled efficacy study was conducted from November 30, 2010, to January 7, 2011 consisting of a volunteer sample of 30 adults ranging in age from 20-70 years old, all suffering from at least one form of lower extremity or back pain. All testing was performed at the Sona Imaging Solutions, Inc., facility in Orange City, Florida.

INTERVENTIONS:
HappyFeet® insoles were worn for a minimum of 6 hours daily for a period of 30 days by each of the participants.

MAIN OUTCOME MEASURES:
Participants rated pain in the foot, knee, leg, back as well as headaches using the metered visual analog scale [VAS] at 0 and 4 weeks. Daily recovery time from pain and fatigue was measured in minutes and reported at 0 and 4 weeks. Venous Doppler ultrasound and echocardiography studies were performed at 0 and 4 weeks, with imaging taken both with and without the insoles. A TekScan® pressure mapping in-shoe device was used with and without the insole, while standing, rocking and walking.

Methodology Used

METHODS:
1910 Consulting in conjunction with Sona Imaging Solutions, Inc., conducted a thirty day research study on the use of HappyFeet® dynamic insoles and the effects of the insoles on the cardiovascular system. Thirty volunteer participants were selected to take part in the research study. Participants were required to answer a pre-testing questionnaire regarding their lifestyle, overall general health, pain perception and any pre-existing conditions. The participants were evaluated by cardiac ultrasound to assess for ejection fraction, cardiac output, stroke volume and heart rate prior to insole use. Participants also underwent non-invasive venous duplex ultrasound testing, in order to evaluate the velocity and spontaneity of venous flow within the popliteal veins bilaterally, immediately prior to and just after initial insole use. The participants were then evaluated using the TekScan® F-Scan® in shoe pressure monitoring system in order to assess for immediate changes in pressure with and without insole use. Participants returned for re- evaluation by ultrasound after regular, daily use of the insoles for thirty days. Of the 30 initial participants 24 returned for follow- up testing. Six did not return, four of whom were given a static, foam insert placebo.

PLACEBO:
The findings of the single returning participant who received the placebo insole were critical in documenting the increase in venous circulatory return with the use of the HappyFeet® insoles, versus the use of a non-dynamic, static insole. The average increase of velocities documented for this participant was 55%, as compared to the venous flow velocities with the non-dynamic, static insole in place.

About The Participants

PARTICIPANT OVERVIEW:
In order to better understand the effectiveness of HappyFeet® insoles, the researchers needed to understand the history of its volunteer participants. Prior to the study and before the insoles distributed, participants were given a questionnaire, which included questions regarding age, general overall health history, lower extremity health, survey of insole use to date, types of footwear worn regularly by participants, basic lifestyle information, daily pain perception, methods used for recovery and the time it takes for participants to return to a “normal” state without pain after a work day. The study included 17 female participants and 11 male participants. Of these volunteers, five ranged in age from 20-30, nine from 31-40, three from 41-50, seven from 51-60, and finally six participants ranged from age 61- 70.

GENERAL HEALTH:
Responses by study participants to the general health questionnaire were as follows: Two participants considered themselves to be in excellent health, 13 in very good health, 14 in good health, and one participant admitted to being in fair health. Contributing factors to these current states of health included heart disease, diabetes, arthritis, scoliosis, high cholesterol, high blood pressure, hypothyroidism, osteo porosis, fibromyalgia, and osteopena. Other contributing factors specifically targeting participants’ lower extremities included flat feet, heel spurs, plantar fasciitis, old injuries, calluses, poor circulation, arthritis of the feet, arthritis of the back, and Morton’s Neuroma. Of the participants studied, 24 said they did not smoke, six did smoke between a quarter to a pack and a half of cigarettes per day. The activity level of the participants was also an important factor when studying the participants’ lifestyle. The amount of time each of them spent standing, walking, and sitting in a 24-hour period gave the research team an idea of how many hours a day would be spent actively wearing the insoles. During the 30 day trial, participants noted that they spent an average of 4.5 hours standing, 3.5 hours walking, and 6 hours sitting per day.

Pain Perception Results

GENERAL PAIN AND RECOVERY:
When asked, half of the participants felt that they had experienced less daily pain; a 43% decrease was noted in general pain by the end of the study. Participants said they had 49% less fatigue and were able to recover 27 minutes faster than before wearing HappyFeet® Insoles. Both the participants and the researchers believed that this was a significant finding.

FOOT:
Though only 20 of the 24 returning participants admitted to having foot pain going into the study, 16 out of those 20 participants noticed a significant reduction of pain after wearing HappyFeet®. The average reduction in foot pain in 16 of the participants was 78%, while seven of the participants noted elimination of foot pain. Of all participants in the study, 54% said they thought they experienced less foot pain while wearing HappyFeet®.

HEEL:
Of the 24 returning participants surveyed, 11 reported having no history of heel pain, while nine participants declared a reduction in heel pain after wearing HappyFeet®. Only four participants were unable to notice a decrease in heel pain.

LEG:
When assessing leg pain, nine of the 24 returning participants observed an average decrease in pain of 69%.

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