Would an iStep Scan to determine specific prefabricated orthotic be more beneficial in the treatment of plantar fasciitis than a standard orthotic?

Research being undertaken by Ms. Fionnuala Geoghegan (BoltonUniversity) and Dr. George Ampat (Feet and Spine).

Funding

Orthotics / Insoles being used for the study is being provided free of charge by Aetrex Inc.

Important

You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully.

What is the purpose of the study?

To find if using a computer matched prefabricated orthotic to a normal off the shelf  pre-fabricated orthotic to treat Plantar fasciitis.

Why have I been chosen?

You have been choosen because we understand that you are

  1. Between the ages of 20 and 75
  2. Suffer from plantar  fascitis.

We cannot select you for the study if you

  1. Have pain and deformity in the foot which is not related to the Plantar fasciits.
  2. Suffer from a serious health condition
  3. Undergone any surgery in the foot during your lifetime.

 Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason.

What will happen to me if I take part?

1)      We will record a baseline history and obtain Aetrex I Step scan and determine the foot type.

2)      Ask you to complete the following the attached questionnaire which includes

a)      Pain severity as assessed using the 11-point NPRS (0 = no pain, 10 = the worst imaginable pain) both early in the morning, and over a day in average.

b)      The Self Reported Foot and Ankle score.

3)      Provide you with a plantar fascia and Achilles tendon stretching exercises with appropriate instruction.

4)      Open presealed envelopes to determine if you belong to Group A or Group B.

5)      If you are in Group A we will provide you with the iStep suggested orthotic and fit according to foot size, comfort and ability to fit into usual footwear. We will document if the chosen orthotic is the 1st, 2nd or 3rd recommendation of the IStep scanner.

6)      If you are in Group A we will provide you with the standard Aetrex L400 orthotic according to foot size, comfort and ability to fit into usual footwear.

7)      The total study will last for 6 months.

8)      We will request you to complete the previous questionnaire containing the

a)      Pain severity as assessed using the 11-point NPRS (0 = no pain, 10 = the worst imaginable pain) both early in the morning, and over a day in average.

b)      The Self Reported Foot and Ankle score.

9)      In addition we will ask you to fill

a)      The Global Rating of Change Scale.

10)  We will request you to fill in all the above at end of month 1, month 3 and month 6.

11)  We would like to review you once again (telephone or personal interview) at the end of the study.

12)   We will collect your data, analyse and compare between wearing the computer matched orthotic to the standard orthotic.

What are the possible disadvantages and risks of taking part?

The need to wear an Orthotic. However this is one of the potential treatments  for plantar fasciitis

What are the possible benefits of taking part?

You could be part of the study to identify if a computer matched prefabricated orthotic is any better than a normal prefabricated orthotic

Will what I say in this study be kept confidential?

All information collected about you would be kept strictly confidential. Privacy and anonymity will be ensured in the collection, storage and publication of research material. Data generated by the study will be retained in accordance with BoltonUniversity's policy on Data Protection. Data generated in the course of the research will be kept securely in electronic format for a period of five years after the completion of a research project.

What will happen to the results of the research study?

We would like to publish the research into scientific journal and present them in learned society meetings

Will I be debriefed at the end of the research?

When the research is over we can send you  a copy of the results for your information.

Who has reviewed the study?

The research has been approved by the University Research Ethics

Committee, University of Bolton.

Disclaimer

Ms. Geoghegan, Ms Hurry and Ms Philip have no conflict of interests to declare. Mr. Ampat has a commercial interest in Feet and Spine which supplies the Orthotics manufactured by Aetrex.

 Concerns

If you have any concerns about the way in which the study has been conducted, please contact us directly in the first instance

Contact details

Ms. Fionnuala Geoghegan

Member of staff, BoltonUniversity

Academic group Engineering, Sports and Science,

University of Bolton,

BoltonOne, Deane Road, Bolton, BL3 5AB

Fjg1@bolton.ac.uk

01204 903614

Dr. George Ampat

Consultant Orthopaedic Surgeon

Feet and Spine

309, Peter House,

Oxford Road

Manchester M1 5AN

george@feetandspine.com

07871590593

 or alternatively the Departmental Research Ethics Officer

 We thank you for your time and effort

 Fionnuala, George, Amber and Richu

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