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Treatments of exercise and orthotics for plantar heel pain: TREADON

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12418153
Enrollment
696
Registered
2022-12-06
Start date
2023-01-30
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar heel pain Musculoskeletal Diseases

Interventions

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 exerci
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

Sponsors

Keele University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026