Effectiveness of radial shock wave treatment or tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain
| ISRCTN | ISRCTN11644582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11644582 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/10/2009
- Registration date
- 17/11/2009
- Last edited
- 09/10/2015
- 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 Evalaution Center
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 | Effectiveness of radial shock wave treatment or tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain: a randomised controlled observer-blinded trial |
| Study objectives | Null hypothesis: Radial shock wave treatment or tissue specific stretching or radial shock wave treatment in combination with tissue specific stretching provide comparable outcomes at 4 months follow-up. |
| Ethics approval(s) | Institutional Review Board of the "Orthopädie im Centrum", Alzey, Germany, approved on the 3rd July 2005 |
| Health condition(s) or problem(s) studied | Plantar fasciopathy |
| Intervention | Patients are randomly allocated to three sessions of radial shock wave treatment or to plantar fascia stretching: Group I: plantar fascia-specific stretching (PFSS), 3 x per day, for eight weeks Group II: Radial shock wave therapy (RSWT), performed 3 x in weekly intervals Group III: PFSS + RSWT Follow-up: at 2 months, four months, and 15 months from baseline. Main follow-up is 4 months. |
| Intervention type | Other |
| Primary outcome measure | Overall heel pain reduction measured by the percentage change of the VAS composite score 4 months after beginning of treatment compared with baseline, with last value carried forward (LVCF) replacement of missing values with the last recorded value. |
| Secondary outcome measures | 1. 6-point Likert scale (fully recovered or significantly improved as success criteria) at 0, 4 and 12 months from baseline 2. Plantar fascia thickness measured before and 4 months and 15 months from baseline 3. Roles and Maudsley Score measured before and 4 months and 15 months from baseline 4. Number of patients achieving 80 points at at month 4, and at month 15 from baseline in the patient's function assessed using the validated 100-point AOFAS (American Orthopaedic Foot and Ankle Society) Ankle-Hindfoot-Score |
| Overall study start date | 01/07/2007 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 250 |
| Key inclusion criteria | 1. History of plantar fasciitis for more than 6 months 2. Numeric Rating Scale (NRS) score persistingly (at least 5 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. Less than 18 years of age 2. Receiving local injections less than 3 months prior to the randomisation visit 3. Receiving physical therapy less than 3 months prior to the randomisation visit 4. Receiving non-steroidal anti-imflammatory drugs (NSAIDs) for any chronic conditions whether or not related to plantar fasciitis prior to the randomisation 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
OrthoTrauma Evalaution Center
Mainz
D-55130
Germany
D-55130
Germany
Sponsor information
OrthoTrauma Evaluation Center (Germany)
Research organisation
Research organisation
Oppenheimer Str. 70
Mainz
D-55130
Germany
Funders
Funder type
Research organisation
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 |
