Treatments of exercise and orthotics for plantar heel pain: TREADON
| ISRCTN | ISRCTN12418153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12418153 |
| IRAS number | 314272 |
| Secondary identifying numbers | CPMS 54528, NIHR131638, IRAS 314272 |
- Submission date
- 16/11/2022
- Registration date
- 06/12/2022
- Last edited
- 28/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Pain under the heel (called plantar heel pain, PHP) is a common condition affecting 1 in 10 adults during their lifetime. It makes walking and completing everyday tasks, including going to work, difficult. Most patients who consult in general practice are given pain medication and advice, yet the problem often continues. In our successful pilot and feasibility trial, foot orthoses and exercises showed promise for improving pain and function, but a large, high-quality main trial is needed to confirm this.
The aim of the TREADON trial is to show whether exercises and/or foot orthoses (shoe insoles) provide more pain relief for adults with plantar heel pain (PHP) than a self-management advice booklet alone, and whether this is good value for money.
Who can participate?
Up to 696 adults, 18 years and over, with Plantar Heel Pain (PHP) will be recruited to this trial.
What does the study involve?
Participants will be randomly allocated to receive one of the following four treatments: 1) Self-management advice (SMA) booklet only (control arm), 2) SMA booklet plus individualised exercises, 3) SMA booklet plus prefabricated foot orthoses, 4) SMA booklet plus individualised exercises and prefabricated foot orthoses.
Patients will be involved in the trial for a duration of 12 months follow up. During this period, all participants will be sent a weekly text-message/ phone call to collect pain scores for up to 12 weeks and then monthly from 3 to 12 months. All participants will be asked to complete a questionnaire at baseline, 3, 6 and 12 months. Half-way through the trial, only treatments that appear to be reducing pain will continue to be offered and the trial will stop recruiting any further participants into this treatment. Patients already randomised to this treatment will continue with this treatment until their participation finishes.
In addition to the text message/phone calls and questionnaire, the participants who are allocated into arms 2 to 4 will receive the trial interventions which will be delivered by site clinicians. These participants will receive up to a total of 6 sessions over 12 weeks. The first session is anticipating to be approx. 1 hour and subsequent visits will be approx. 30 minutes.
What are the possible benefits and risks of participating?
Self-management advice, exercises and shoe insoles are commonly used treatments for plantar heel pain. Although no direct benefits can be guaranteed, 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, exercises or shoe insoles can cause temporary mild soreness and in some limited cases, shoe insoles may cause blisters. The questions asked on the questionnaires are similar to those that GPs or other healthcare professionals might ask about pain and related symptoms but you could contact your GP if you would benefit from speaking to somebody about how you are feeling after answering these questions. Unfortunately, travel and car parking costs that may apply when attending clinic appointments cannot be reimbursed. We are also unable to pay for any charges incurred for sending SMS text messages as part of the trial.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
January 2022 to November 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Laura Bowyer, l.bowyer@keele.ac.uk
Contact information
Scientific
School of Medicine
Keele University
Keele
ST5 5BG
United Kingdom
 ORCID ID |
0000-0002-8954-7082 |
|---|---|
| Phone | +44 1782 734715 |
| e.roddy@keele.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.keele.ac.uk/treadon/ |
| Scientific title | Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: a randomised multi-arm multi-stage (MAMS) adaptive trial |
| Study acronym | TREADON |
| Study hypothesis | The aim of the TREADON trial is to show whether exercises and/or foot orthoses (shoe insoles) provide more pain relief for adults with plantar heel pain (PHP) than a self-management advice booklet alone, and whether this is good value for money. |
| Ethics approval(s) |
Approved 22/11/2022, West of Scotland Research Ethics Committee 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 3140213; WoSREC5@ggc.scot.nhs.uk), ref: 22/WS/0165 |
| Condition | Plantar heel pain |
| Intervention | Eligible patients who consent to take part in the trial will be allocated to one of four treatment arms: 1. Self-management advice (SMA) booklet (control arm) 2. SMA booklet plus individualised exercises (SMA-exercises) 3. SMA booklet plus pre-fabricated foot orthoses (SMA-orthoses) 4. SMA booklet plus individualised exercises and pre-fabricated foot orthoses (SMA-combined). A self-management (control) arm has been included as this is the closest intervention to GP usual care described as a watchful waiting approach. The duration of the intervention regardless of group allocation will be 12 weeks. Participants will be asked not to use other types of treatments, other than medication that their GP has provided, during the intervention period if possible; however, any additional healthcare and self-care use will be recorded in the 12-week follow-up questionnaire, 6-month follow-up questionnaire and 12-month follow-up questionnaire. Participants will be sent a weekly text-message to collect pain scores for up to 12 weeks and then monthly from 3 months to 12 months (Patients who do not wish to use text-messaging will be offered the option of brief telephone calls at the consent stage) as well as a questionnaire at 12-weeks, 6 and 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Change in plantar heel pain intensity score is measured using a 0-10 numeric rating scale (NRS) at baseline and an average score from 6, 7, 8, 9, 10, 11 and 12 weeks. |
| Secondary outcome measures | 1. Short-term pain trajectories measured using a 0-10 NRS at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 weeks 2. Pain measured using a 0-10 NRS at baseline, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months 3. First step pain measured using a 0-10 NRS at baseline, 3, 6 and 12 months 4. Physical function measured using Foot Function Index disability (9 items) and activity limitation subscale (5 items), 10 point Likert scale at baseline, 3, 6 and 12 months 5. Patient global rating of change using global impression of change score (6 point scale) at baseline, 3, 6 and 12 months 6. Pain self-efficacy using pain self-efficacy questionnaire (10 items, 6 point scale) at baseline, 3, 6 and 12 months 7. Illness perceptions using brief illness perception questionnaire (8 items, 10 point scale) at baseline, 3, 6 and 12 months 8. Health related quality of life using EuroQuol:EQ5D-5L at baseline, 3, 6 and 12 months 9. Ability to work using work loss and presenteeism questionnaire at baseline, 3, 6 and 12 months 10. Treatment satisfaction using self reported treatment adherence, satisfaction with care and treatment credibility questionnaires at baseline, 3, 6 and 12 months 11. Cost-effectiveness using self-reported healthcare use for plantar heel pain at baseline, 3, 6 and 12 months. |
| Overall study start date | 01/01/2022 |
| Overall study end date | 30/11/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 696; UK Sample Size: 696 |
| Participant inclusion criteria | 1. Adults aged 18 years and over 2. Self-reported localised pain under the heel which is worst when standing after rest and after prolonged weight-bearing 3. Symptom duration at least 4 weeks with pain > = 2 (0-10 Numerical Rating Scale [NRS]) 4. Access to a mobile phone that can send/receive SMS text-messages or a landline telephone 5. Able and willing to participate and provide informed consent |
| Participant exclusion criteria | 1. Inflammatory arthritis, systemic lupus erythematosus, gout, fibromyalgia 2. Heel pain of neurologic cause e.g. tarsal tunnel, entrapment neuropathy, radiculopathy 3. Serious pathologies requiring urgent medical attention (e.g. trauma, tumour, infection) 4. Current treatment or treatment in the last 3 months by a physiotherapist or podiatrist for PHP, or currently using a contoured foot orthosis 5. Previous surgery or awaiting surgery on the affected foot 6. Corticosteroid injection into the affected foot in the last 3 months 7. Extracorporeal shockwave therapy to the affected foot in the last 3 months 8. Unlikely to tolerate the interventions (e.g. allergies to common orthotic device materials) or unable to attend for treatment |
| Recruitment start date | 30/01/2023 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Newport Road
Albrighton
Wolverhampton
WV7 3FA
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sheffield
S10 2SB
United Kingdom
8 Victoria Road
Leeds
LS6 1PF
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Hamilton
ML3 0TA
United Kingdom
10 Arthur Street
Ayr
KA7 1QJ
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Leighton
Crewe
CW1 4QJ
United Kingdom
Sponsor information
University/education
Keele
Newcastle-under-Lyme
ST5 5BG
England
United Kingdom
| Phone | +44 1782 732975 |
|---|---|
| research.governance@keele.ac.uk | |
| Website | http://www.keele.ac.uk/ |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Summary results will also be shared with participants, participating GP and NHS sites and be publicly available on the TREADON trial website (web address tbc). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Data Custodian Dr Martyn Lewis a.m.lewis@keele.ac.uk, type of data = anonymised password protected database file release in suitable format (e.g. Excel, Stata, SPSS), available after main publication of the primary and key trial results (available indefinitely), shared with password protection, for analyses deemed suitable for purpose (following review by the Keele Data Custodian Academic Proposal (DCAP) committee), by electronic password protected transfer by the data custodian, consent for research study has been obtained from participants (data will be anonymised data release), data will be anonymised, ethics consideration around confidentiality/ anonymisation of the data and suitability of data sharing (as deemed whether fit for purpose). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
28/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/01/2025 to 30/09/2025.
2. The overall end date was changed from 31/07/2026 to 30/11/2026.
3. The plain English summary was updated to reflect these changes.
26/02/2024: The plain English summary was updated with a new contact.
23/02/2024: The following changes were made to the trial record:
1. The ethics approval was added.
2. The study website was added.
3. The study participating centres St Georges Hospital, Leighton Hospital, Pinderfields Hospital were removed and Mid Yorkshire Teaching NHS Trust, Mid Cheshire Hospitals NHS Foundation Trust were added.
16/11/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
