FASCIA-BAR™ Clinical Study

Clinical Trial at Des Moines University, Iowa

A clinical study was put together with 32 individuals experiencing heel pain. Of the 32 people completing the study,

27 had identified Plantar Fasciitis
1 had left Achilles Tendonitis for 4 years
1 had left Calcaneal Bursitis
3 had general Heel Pain and suspected Heel Spurs

All participants with the exception of 2 had tried various over the counter heel cups or heel spur pads as well as other cushions, gels and arch supports. 5 had previous cortisone injections to help relieve their heel pain. In a "1 to 5" pain relief category, all had varying degrees of success or failure with the collection of over the counter products, none reaching greater than "2" in the pain relief category. 3 of the people who had cortisone injections showed reduced pain for several weeks before the pain reoccurred.

Of the 32 people completing the eight-week use of the HTP Heel Seat with the patented fasciitis bar, the average in a "1 to 5" pain reduction relief category was a "4"; 1 person reported a "2"; 11 people reported a "5"; all other people reported a "4". Upon completion, the 32 people had to return the HTP sample and fill out the final paperwork. Out of the 32 participants, 31 requested to retain the HTP Heel Seat.


Double Blind Clinical Trial Results

The purpose of this study was to determine if one of the methods for the treatment of heel pain is better than another. Currently, plantar fasciitis can be treated conservatively with non-steroidal anti-inflammatory medications, icing, stretching, or steroid injections. Other treatments include: shoe inserts, orthotics, taping the foot, relative rest, and in advanced cases, surgery. Some physicians use one or more of the above named treatments together. However, in this study, we used two different forms of shoe inserts as a form of a low cost, conservative way to treat plantar fasciitis.

In our study, 32 participants were randomly assigned into one of two treatment groups. The control group received "Dr. Scholl's Massaging Gel Heel Cushion," and the experimental group received the HTP "Heel-That-Pain Heel Seat Insert."

The requirements for our participants included healthy adults at least 18 years old with plantar heel pain. They were dismissed from the study if they had past trauma to the painful heel within the past 6 years, prior surgery for plantar fasciitis, immunocompromised (because of diabetes, HIV, or corticosteroid therapy) or if they had a systemic illness or neuropathy. They were not to seek any other treatment for their heel pain during the course of the trial. Such treatments not allowed included: non-steroidal anti-inflammatory medications, icing, stretching, steroid injections, other shoe inserts orthotics, taping the foot, relative rest or surgery.This study was designed and executed by third year podiatric medical students who were interested conducting research. The study was conducted under the supervision of Denis Freedman, DPM and James Mahoney, DPM. The participant population with heel pain was gathered via advertising through flyers and the local area newspaper. Participants were pre-screened over the phone with the above criteria and were instructed to attend an on-site visit to the Medical Education Center at the Des Moines University, College of Podiatric Medicine and Surgery.

Here, participants were screened to make sure the pain was indeed in the plantar aspect of the heel and were given questionnaires regarding their pain and disability. Specifically, we asked each participant a 15 question Foot Function Index. On a scale of 0-10, they were to answer questions about daily pain in activities and difficulty in doing those activities. The inserts were distributed and they were instructed to wear the inserts in one-hour daily increments. As a way to gauge the participants' progress, three 3-week phone follow-ups was done and the same 15 question Foot Function Index was asked again. The duration of the study was 9 weeks. Refer to the attached data.

A total of 56 people responded and 32 completed the study. Reasons for termination included: increase in heel pain, use of other treatment modalities, unable to contact, and no-shows to the initial on-site visit.

A total of 17 participants were randomly assigned to use the HTP heel seat and 17 participants were randomly assigned have the Dr. Scholl's Massaging Gel Heel Cushion. On the average, on a scale of 1-10, the HTP group had a decrease of 1.8 points, while the Dr. Scholl's group had only a decrease of 0.9.

In conclusion, the HTP group had 2x the pain relief than the Dr. Scholl's group. The HTP heel seat insert is a more effective way of relieving pain from the plantar, or bottom of the heel. Should you have any questions about this study, feel free to contact us here.

This research proposal submitted to the Institutional Review Board at Des Moines University was processed by a full committee review. The Institutional Review Board approved this protocol as of January 13, 2004.

Clinical Trial at Des Moines University
Amy Pitzer, Denise Freeman, DPM, James Mahoney, DPM
S. Juanita Robel, PT, Chairperson


Clinically Proven for all forms of Heel Pain such as Plantar Fasciitis & Heel Spurs

Are You Ready To "Heel That Pain"?