Heel Pain, Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciopathy
Conditions
Keywords
Plantar fasciopathy, Plantar fasciitis, Heel pain, Barefoot walking, Foot pain, Musculoskeletal, Physical therapy
Brief summary
The goal of this clinical trial is to learn if a barefoot walking programme can treat plantar fasciopathy (heel pain) in adults aged 18-70. The main questions it aims to answer are: * Does a barefoot walking programme reduce heel pain compared to a standardised stretching and strengthening programme? * Does a barefoot walking programme improve foot function and quality of life in adults with plantar fasciopathy? Researchers will compare a barefoot walking programme to a standardised stretching and strengthening programme to see if barefoot walking is an effective conservative management approach for plantar fasciopathy. Participants will: * Be randomly assigned to either a barefoot walking programme or a stretching and strengthening programme * Complete a 12-week home-based exercise programme * Complete short weekly questionnaires throughout the 12 weeks * Complete 3 follow-up surveys over 6 months after the intervention ends * Receive education on load management and plantar fasciopathy
Interventions
BEHAVIORALBarefoot Walking Programme
A structured 12-week progressive home-based barefoot walking programme on grass for adults with plantar fasciopathy. Participants gradually increase the duration and frequency of barefoot walking over the 12-week period. Education on plantar fasciopathy and load management principles is provided. Adherence and symptom response are monitored via weekly questionnaires.
BEHAVIORALStandardised Conservative Care
A structured 12-week standardised home-based stretching and strengthening programme for adults with plantar fasciopathy. The programme includes plantar fascia and calf stretching alongside progressive foot and lower limb strengthening exercises. Education on plantar fasciopathy and load management principles is provided. Adherence and symptom response are monitored via weekly questionnaires
Sponsors
Elisabetta Brigo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the interventions (home-based exercise programmes), blinding of participants and the care provider was not feasible. The investigator analysing the outcome data will be blinded to group allocation during data analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-70 years; * Clinical diagnosis of Plantar Fasciopahty, defined by: a) Pain localised to the medial calcaneal tubercle of sharp or stabbing quality; b) Pain worst with the first few steps in the morning or after a period of rest (first-step pain); c) Pain reproduced with palpation of the medial calcaneal tubercle OR positive Windlass Test; * Symptom duration greater than 4 weeks; * Able to walk independently without a mobility aid * Able to provide informed consent and comply with study protocol
Exclusion criteria
* Prior surgery on the affected foot * Diabetes with peripheral neuropathy or other neurological condition affecting lower limb sensation or motor control * Active inflammatory arthropathy, uncontrolled vascular disease, or inability to walk unaided * Current or recent (less than 6 months) bony stress fracture or other acute foot or ankle injury on the affected side * Pregnancy during the intervention period * BMI greater than 40 kg/m² * Corticosteroid injection to the affected foot within the previous 3 months * Night splints initiated less than 4 weeks prior to enrolment * Any condition that would make participation unsafe, including open foot wounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-Step Pain | From the baseline assessment (Week 0) until end of intervention (Week 12) | Changes in average first-step morning pain over the last 7 days measured with the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function | From baseline (Week 0) until the end of intervention (Week 12) | Changes in foot function measured with the Foot Function Index (FFI). Higher scores indicate worse function. |
| Adherence | Weekly during the 12-week intervention period. | Percentage of prescribed home exercise sessions completed, recorded via participant self-report log throughout the 12-week intervention period. |
| Cost-Effectiveness (Incremental Cost-Effectiveness Ratio) | At week 12 and at 6 months post-intervention (week 36). | Incremental cost per unit of clinical improvement between groups, expressed as cost per 1-point improvement in pain (NPRS) and cost per 10% improvement in foot function (FFI). Total costs will include healthcare utilisation and participant out-of-pocket expenses. Two separate ICERs will be calculated. |
| Adverse Events | Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention. | Any training-related injuries, falls, skin injuries, or symptom exacerbations reported by participants throughout the study period, recorded via weekly questionnaires and follow-up surveys. |
Countries
Ireland
Outcome results
None listed