RecruitingNAINTERVENTIONAL

HeEL Pain Pathways Feasibility Study

If you have ongoing heel pain, known as plantar fasciitis, this study might be for you. We're exploring different combinations of treatments to find the best way to help people. Think of this as a practice run for a larger study. We're not testing new or experimental treatments; instead, we're using treatments already available in the NHS. Participants will try different combinations of these standard treatments, like virtual consultations, self-help videos, special shoe inserts (orthotics), or 'shockwave therapy'. We want to understand what works well and what doesn't, and hear about your experiences. Your feedback will help us design a bigger study to improve how heel pain is treated in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Cardiff and Vale University Health Board

Enrolment target

Start

02 Sep 2024

Estimated completion

28 Nov 2025

Plantar Fasciitis

What is this study about?

Many people suffer from heel pain, known medically as plantar fasciitis, and doctors are still trying to figure out the most effective ways to treat it. This particular project isn't about finding a brand-new cure, but about preparing for a much bigger, future study that will explore the best treatment paths for this type of pain.

Imagine this study as a 'test drive'. We're trying out the study methods and asking for people's feedback to make sure everything runs smoothly for the main event later on. All the treatments used in this study are already available within the NHS; nothing is experimental or unusual. We're simply looking at different combinations of these established treatments to see which ones might work best for different people. Your input is really valuable in helping us get this right for future patients.

By taking part, you'll help us understand if the study design makes sense, if enough people are interested in joining, and if the proposed treatment plans are acceptable and helpful for patients and healthcare staff. This information is crucial for us to decide whether to go ahead with the full-scale study, which could eventually lead to better care for everyone with heel pain.

Key takeaways

This study is a 'practice run' to prepare for a larger study on heel pain.
It uses standard NHS heel pain treatments, not experimental ones.
You'll try different combinations of treatments like virtual chats, self-help, insoles, or shockwave therapy.
Your feedback is key to helping us design a better future study.
You'll fill out questionnaires and keep a diary for about six months.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older and currently experiencing heel pain in one or both feet. It's important that you can understand and speak English or Welsh, and you'll need access to the internet and email, or a DVD player, as some of the study materials are provided online or by video. You can get help from family or friends if you need technical support.

There are also some reasons why you wouldn't be able to join. For example, if you've already had specific exercise treatments or used special insoles in the last three months, or if your heel pain is due to a serious injury, a major health condition like diabetes, an autoimmune disease, or a blood clotting problem. We also can't include pregnant individuals, or those with certain medical devices like pacemakers.

If you've recently had a cortisone injection for your heel pain (within the last two weeks), or if other health issues make it hard for you to do simple exercises, you also wouldn't be able to take part. It's always best to discuss your full medical history with the study team to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you currently have ongoing heel pain?
Can you speak and understand English or Welsh well?
Do you have access to the internet and email, or a DVD player?
Have you avoided specific exercise treatments or special insoles in the last 3 months?
Are you free from conditions like diabetes, severe injuries, or autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of 50 people with heel pain. Initially, you'll be split into two groups by chance: one group will have a virtual chat with a foot expert (podiatrist), and the other will receive a self-help video. For about four weeks, you'll follow the advice given. If your heel pain hasn't gotten better after this time, you'll be invited for an in-person assessment at a clinic.

At this point, you'll again be randomly assigned to receive either special shoe inserts (orthotics) or a treatment called 'shockwave therapy,' which uses sound waves on the affected area. Throughout the study, you'll be asked to fill out questionnaires and keep a diary about your pain and progress for six months. Some participants will also be invited to have an interview or join a small group discussion to share their experiences.

Potential risks and benefits

Taking part in this study means you'll receive treatments that are already routinely offered in the NHS for heel pain. While there's no guarantee your pain will improve, you might find relief from your symptoms through the different treatment combinations. As this is a 'test run' study, the main benefit is helping us design a better, larger study in the future, which could ultimately lead to improved care for others with heel pain. All treatments used are standard, so they carry the usual, known risks associated with them, which the study team will explain. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Podiatry Department, Cardiff Royal Infirmary
Verified postcode
Cardiff, United Kingdom· Recruiting

Common questions

What is plantar fasciitis?

Plantar fasciitis is a common condition that causes pain in the bottom of your heel, often worse with the first steps in the morning or after rest.

Are the treatments in this study experimental?

No, all treatments used in this study, like virtual consultations, self-help videos, shoe inserts, and shockwave therapy, are standard treatments already available in the NHS.

Will I definitely get better if I join?

There's no guarantee your pain will go away completely, but you will receive standard NHS treatments and your experiences will help us improve future care.

How long will I need to be in the study?

You will be asked to complete questionnaires and diaries for about six months in total.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and this won't affect your medical care.

How to find out more

Nia J Jones, PhD

nia.jones16@wales.nhs.uk +442921844771 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.