Plantar heel pain Musculoskeletal Diseases Plantar heel pain
Conditions
Interventions
The participants will be randomly allocated to the following three arms:
1. Intervention group 1: Orthaheel® regular. This is a 3/4 length insole with arch shape which is positioned under the heel a
Sponsors
SSL International (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants between the ages of 18 and 65 years old 2. Participants with self-reported plantar heel pain with a minimum of 4 weeks duration 3. Self-reported plantar heel pain who score at least 40 mm on a 100 mm visual analogue scale (VAS) for pain 4. Participants with plantar heel pain in the 2 days prior to recruitment 5. Participants who agree to wear the insoles provided for at least 4 hours each day 6. Participants who give written informed consent
Exclusion criteria
Exclusion criteria: 1. Participants reporting acute injury to the foot at the onset of the plantar heel pain 2. Participants with posterior or medial/lateral heel pain or any secondary pain elsewhere in the foot since the onset of plantar heel pain 3. Participants with significant musculo-skeletal disease diagnosed such as rheumatoid arthritis, hip, knee or back pain 4. Participants with sensory or motor function disease such as diabetes 5. Participants who are pregnant or breast-feeding 6. Participants who have received or self-administered treatment for the heel pain in the previous 4 weeks 7. Participants who have received corticosteroid injection therapy in the heel in the previous 3 months 8. Participants that were previously in this study 9. Participants that were in another study within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Foot pain 2. Foot health related function Foot pain will be measured primarily using a 0-10 visual analogue scale. The Foot Health Status Questionnaire (FHSQ) will be used to provide categorical assessment of pain and foot health related function. Primary timepoint of interest: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Use of insoles (in time) 2. Foot pain at 3, 6 and 12 months (see Primary outcome measures for details) 3. Foot health related function at 3, 6 and 12 months (see Primary outcome measures for details) | — |
Countries
United Kingdom
Outcome results
None listed