Skip to main content

HELPP (HeEL Pain Pathways) Feasibility Study

What we did and why:

Heel pain (also known as plantar fasciitis) is a common condition that can have a big impact on people’s daily lives. Patients can often manage it themselves at home if they learn how to correctly stretch their muscles and follow other advice from professionals. People with ongoing pain may need to visit a podiatrist for more advanced treatments such as shoe inserts or ‘shockwave’ therapy.

In a typical clinical trial, researchers compare individual treatments against one another. Because we wanted to learn about whole treatment pathways, we used a special trial design. We tested combinations of different treatments at different times, one after another. This design is useful because it will help us in future to personalise treatment pathways depending on individual patient’s needs. A full-scale trial will produce scientific evidence that will support podiatrists to make good decisions.

Before running a long and expensive clinical trial, it is helpful to run a small-scale study to test the methods. The HELPP (HeEL Pain Pathways) Study aimed to test the feasibility of using the special trial design to develop personalised treatment pathways for people with heel pain. We collected and analysed information from patients and healthcare staff using questionnaires and interviews.

Main messages:
  • The trial design worked in the way we hoped, with patients following different treatment pathways depending on how much their pain improved.
  • At first, we found it hard to encourage enough people to take part in the study. Some people decided to leave before the end of their six-month follow-up. We made it easier for people to take part by allowing people to refer themselves to the study directly, and by making the questionnaires available online.
  • We used feedback from patient and public partners, study participants, researchers, and podiatrists to suggest improvements to the study methods.
  • If the recommended changes are made, it is feasible for a full-scale trial to go ahead. Comparing the effectiveness of personalised treatment pathways could lead to better outcomes for patients and save money for the health service. 

Study details

  • Full title of clinical trial: Feasibility of developing personalised treatment pathways for relief of plantar heel pain using a sequential multiple assignment randomised trial (SMART) study design
  • Study design: Feasibility sequential multiple assignment randomised trial (SMART)
  • Chief Investigator: Dr Nia Jones
  • Sponsor: Cardiff and Vale University Health Board
  • Sponsor ref: 8651
  • Funding: Health and Care Research Wales - Research for Patient and Public Benefit
  • Registered at: clinicaltrials.gov/study/NCT06967168 

 

Flow chart for HELPP participants