The TREADON trial

The TREADON trial is a clinical trial that is testing treatments of exercise and orthotic devices (shoe insoles) for plantar heel pain.

Are you aged 18 or older? Do you suffer with pain under the heel (called plantar heel pain or plantar fasciitis)?

If you answered 'yes' to these two questions you may be eligible to take part. Please explore this website to find out more information about the TREADON trial.

To receive more information about the trial or to see if you can take part, please register your interest by completing the form via the link above or call the TREADON trial team on 01782 732950.

We are asking adults aged 18 years and over, who are experiencing heel pain, to let us know if they would like to receive further information about the TREADON trial, or would like to take part. If interested, we invite you to complete a reply form and, if applicable, foot pain survey.

The aim of the foot pain survey is to find out about any foot pain you may have experienced in the last month. This is the first stage of the TREADON trial and it will help us check that you are eligible to progress to the next stage.

If you are interested and meet the initial eligibility you will be sent a consent form and questionnaire. A TREADON researcher will call you to go through these documents and answer any questions you have about the trial, and check that you are eligible and that it is safe for you to take part.

If after this conversation you wish to take part, it will involve:

1. Completing a consent form and questionnaire, before the start of trial treatment.
2. Receiving one of the treatments outlined below.
3. Receiving and replying to a weekly text message, or phone call, over the 12-week trial period. After 12 weeks you will receive these text messages/phone calls monthly, up until your 12 month follow up.
4. Receiving and completing a postal/ online questionnaire at 12 weeks, 6 months and 12 months.
5. You may be asked to have up to 6 sessions with either a physiotherapist or a podiatrist, over the 12-week trial period.
6. You may also be asked to complete a weekly diary.

Participants who agree and are suitable to take part in the TREADON trial will be allocated by chance (called randomisation) to one of the following treatments:

1. Self-management advice

You will be provided with an advice booklet containing information and advice about plantar heel pain. The booklet provides information on stretching exercises and self-help messages about pain relief, suitable footwear, rest and weight loss that can all help to reduce pain in the heel.

2. Self-management advice plus stretching and strengthening exercises

You will receive an advice booklet and an assessment of your foot to decide the best exercises for your plantar heel pain. This assessment will be performed at a clinic by either a physiotherapist or podiatrist. You will be taught how to carry out these exercises so that you can continue doing them in your own time. You may be asked to attend up to a maximum of six sessions with the physiotherapist or podiatrist over a 12-week treatment period.

3. Self-management advice plus shoe insoles

You will receive an advice booklet and an assessment of your foot. This assessment will be performed at a clinic by either a physiotherapist or podiatrist. The assessment is required to fit a shoe insole to help your plantar heel pain. You will be taught how to use the insole and asked to wear it for at least 4 hours per day. You may be asked to attend up to a maximum of six sessions with the physiotherapist or podiatrist over a 12-week treatment period.

4. Self-management advice and a combination of both exercise and shoe insoles

You will receive an advice booklet alongside a combination of exercise and shoe insoles (see above 2. & 3.). You may be asked to attend up to a maximum of six sessions with the physiotherapist or podiatrist over a 12-week treatment period.

For the 12 weeks of the trial, we ask you not to use any other types of treatment or devices for your heel pain, other than medication that your GP may provide.

We do not know which treatment works best for patients so it is important to remember that everyone who takes part in the trial, whichever treatment they receive, is providing an equally valuable contribution.

We will monitor the participants carefully through the trial. When 80 people have been recruited to each treatment, we will examine the information you and other participants have provided. If one of the treatments seems to be much less effective than the others, then we will stop recruiting any further participants into this treatment. Patients already randomised to this treatment will continue with this treatment until their participation finishes.

The decision about which treatment you receive is made randomly by a computer programme at Keele Clinical Trials Unit (CTU) at Keele University. Like rolling dice, you will have an equal chance of being allocated to any of the treatments. Dividing people in this random way is important because it is the best way to compare treatments fairly.

It is important to remember that everyone who takes part in the trial, whichever treatment they receive, is providing an equally valuable contribution.

Self-management advice, exercises and shoe insoles are commonly used treatments for plantar heel pain. Although no direct benefits can be guaranteed for you, your heel pain may improve over the course of the treatment and involvement in the trial will provide important information about plantar heel pain.

The treatments used in this trial are considered to be safe and are commonly used in routine clinical care by physiotherapists and podiatrists. In some individuals, shoe insoles or exercises can cause temporary mild soreness and in some limited cases, blisters.

If you experience any unpleasant side effects from the treatments you receive within the trial, or any problems with your insoles, you can telephone the trial team at Keele CTU on 01782 732950 and quote TREADON, or email ctu.treadon@keele.ac.uk

The questions you are asked on the questionnaires are similar to those that your GP or other healthcare professional might ask you about your pain and related symptoms.

If you would like to speak to somebody about how you are feeling after answering these questions you could contact your GP. Alternatively, if you would like to speak to somebody about the trial, you can call the TREADON trial team during office hours on 01782 732950.

You may need to attend a TREADON Physiotherapy/ Podiatry Clinic up to 6 times. We are running clinics in 14 different locations, please click here to view where the clinics are held.

Where you receive your treatment will be based on your postcode. You must be willing to attend one of these clinics for up to 6 times. We cannot reimburse you for any travel and car parking costs that you may have to pay for attending clinic appointments.