Plantar heel pain Signs and Symptoms Plantar heel pain
Conditions
Interventions
Participants will be randomised to one of four intervention arms. Randomisation will be conducted at Keele CTU using block randomisation (block size of 4) to ensure parity in allocation from each of t
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged = 18 years 2. Self-reported localised pain under the heel which is aggravated by weight bearing activities, worst when first standing or after a period of rest, especially on getting out of bed in the morning, or following periods of prolonged sitting 3. Symptom duration of episode of at least 4 weeks with a minimum pain score of 2 on a Numerical Rating Scale (NRS 0-10) 4. Owns or has access to a mobile phone that receives text messages or a landline telephone 5. Able and willing to participate and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis, reactive arthritis, systemic lupus erythematosus, gout, psoriatic arthritis), fibromyalgia 2. Serious pathologies or serious suspected pathologies (e.g. malignancy, trauma, infection) 3. Current treatment for plantar heel pain or treatment in the last 3 months by a physiotherapist or podiatrist 4. Previous surgery or on waiting list for surgery on the affected foot 5. Corticosteroid injection into the affected foot in last 3 months 6. Unwilling or unable to participate with the interventions or unable to attend clinics for treatment 7. Unable (even with telephone support) to complete follow-up questionnaires written in English or unable to receive text messages or phone calls 8. Known skin allergies to common orthotic device materials (e.g. adhesives, latex, sock dyes, certain shoe types)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of primary outcome measure for the main trial, using the following options: 1. Average plantar heel pain over the last 7 days is measured using the Numerical Rating Scale (NRS 0-10) of plantar heel pain collected at baseline in the self report questionnaire, weekly via text messaging for 12 weeks and at the 12 week follow up via self report questionnaire 2. Foot pain is measured using the Manchester Foot Pain and Disability Index (MFPDI) pain subscale at baseline and 12 weeks via self report questionnaire 3. Foot pain is measured using the Foot Function Index Pain Subscale (FFI-PS) at baseline and 12 weeks via self report questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Process outcomes: 1. Adherence to treatment is measured using adherence with interventions (variable number according to intervention) adapted from previous research at 12 weeks via self report questionnaires and through weekly self report diaries 2. Satisfaction with treatment is measured using a 3 x Likert scale adapted from previous research at 12 weeks via self report questionnaires 3. Credibility of treatment is measured using a 5 x Likert scale adapted from previous research at 12 weeks via self report questionnaires 4. Adverse events are measured at 12 weeks via self report questionnaires and through weekly self report diaries 5. Patient views on treatment adherence, satisfaction and credibility are measured using free text at 12 weeks via self report questionnaires Clinical outcomes: 1. Presence of pain in the heel is measured with a yes/no question at baseline via self report questionnaires weekly via text messaging for 12 weeks and at 12 week follow-up via self report questionnaires 2. First step pain is measured using a Numerical Rating Scale 0-10 at baseline and 12 weeks via self report questionnaires 3. Plantar heel pain at 12 weeks relative to the pain at baseline is measured using the Global Impression of change score at 12 weeks via self report questionnaires 4. Presence of pain in the heel is measured with a yes/no question at baseline via self report questionnaires, weekly via text messaging for 12 weeks and at 12 week follow-up via self report questionnaires 5. Foot Function is measured using the Foot Function Index disability (9 items), activity limitation subscale (5 items) and a 10 point Likert scale at baseline and 12 weeks via self report questionnaires 6. Foot function and appearance is measured using the Manchester Foot Pain and Disability Index (MFPD | — |
Countries
England, United Kingdom
Outcome results
None listed