Plantar fasciopathy Musculoskeletal Diseases Fibroblastic disorders
Conditions
Interventions
Group I: plantar fascia-specific stretching, 3x per day, for eight weeks
Group II: Shock wave therapy, performed 3x in weekly intervals
Follow-up: at 2 months, 4 months, 15 months from baseline
Sponsors
OrthoTrauma Evaluation Centre (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. History of plantar fasciitis for less than 6 weeks 2. Numeric Rating Scale (NRS) score = 6 points for pain during the first few steps of walking in the morning 3. Localised pain on palpation of the proximal plantar fascia 4. Be willing to abstain from any other treatments or medications during the treatment and follow-up period
Exclusion criteria
Exclusion criteria: 1. < 18 years of age 2. Receiving local injections prior to the randomisation visit 3. Receiving physical therapy prior to the randomisation visit 4. Receiving NSAIDs for any chronic conditions whether or not related to plantar fasciitis prior to the randomization visit 5. Receiving systemic therapeutic anticoagulants 6. Bilateral plantar fasciitis 7. History and/or physical findings of lower extremity dysfunction, local arthritis, generalised poly-arthritis, rheumatoid arthritis, ankylosing spondylitis, local arthrosis. 8. Neurologic abnormality (changes of deep tendon reflexes, motor or sensory deficit) 9. Arthrosis of the foot or ankle, as confirmed by x-ray diagnosis (AP, lateral views) 10. Previous surgery of the foot 11. Participation in a Workman?s Compensation Program or plans to apply for the Program 12. Thrombopathy, infection, tumour, diabetes mellitus, systemic lupus, severe cardiac disease or other severe systemic diseases 13. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is prospectively defined as change of the sum score of the pain subscale of the Foot function Index (PS-FFI) from baseline to month two. Further primary efficacy criteria are the change of item ´2` of the PS-FFI from baseline to month two, and the response rate to question #6 (satisfaction with treatment) of the subject-relevant outcome measures (SROM) questionnaire at month two from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of the sum score of the PS-FFI from baseline to month four, and to month fifteen; change of the score of item ´2` of the PS-FFI from baseline to month four, and to month fifteen; association of treatment with response rates of the SROM questionnaire at month two, at month four, and at month fifteen. | — |
Countries
Germany
Outcome results
None listed