Plantar Fascia-Specific Stretching (PFSS) versus Radial Shock Wave Therapy (SWT) as Initial Treatment of Plantar Fasciopathy
| ISRCTN | ISRCTN03438342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03438342 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/11/2009
- Registration date
- 03/12/2009
- Last edited
- 03/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jan D. Rompe
Scientific
Scientific
OrthoTrauma Evaluation Center
Oppenheimer Str. 70
Mainz
D-55130
Germany
Study information
| Study design | Randomised controlled observer blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Plantar Fascia-Specific Stretching (PFSS) versus Radial Shock Wave Therapy (SWT) as Initial Treatment of Plantar Fasciopathy: a randomised controlled observer-blinded trial |
| Study objectives | Null hypothesis: PFSS or SWT for patients with a previously untreated unilateral plantar fasciitis (PF) of up to six-week duration provide comparable outcomes at 2 months follow-up |
| Ethics approval(s) | Institutional Review Board of the "Orthopädie im Centrum", Alzey, Germany, approved on 4th July 2005 |
| Health condition(s) or problem(s) studied | Plantar fasciopathy |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 | 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. |
| Overall study start date | 01/08/2005 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 Workmans 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 |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
OrthoTrauma Evaluation Center
Mainz
D-55130
Germany
D-55130
Germany
Sponsor information
OrthoTrauma Evaluation Centre (Germany)
Hospital/treatment centre
Hospital/treatment centre
Oppenheimer Str. 70
Mainz
D-55130
Germany
Funders
Funder type
Hospital/treatment centre
OrthoTrauma Evaluation Center (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
