Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Institutional Review Board of the "Orthopädie im Centrum", Alzey, Germany, approved on the 3rd July 2005
Study design
Randomised controlled observer-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2007
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Germany
Trial participating centre
OrthoTrauma Evalaution Center
Mainz
D-55130
Germany
Funders
Funder type
Research organisation
Funder name
OrthoTrauma Evaluation Center (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary