Plantar Fascia-Specific Stretching (PFSS) versus Radial Shock Wave Therapy (SWT) as Initial Treatment of Plantar Fasciopathy

Completed

Conditions: Plantar fasciopathy
Musculoskeletal Diseases
Fibroblastic disorders

Registration Number: ISRCTN03438342

Lead Sponsor: OrthoTrauma Evaluation Centre (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.