Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Institutional Review Board of the "Orthopädie im Centrum", Alzey, Germany, approved on 4th 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
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
Phase
Not Applicable
Drug names
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 trial start date
01/08/2005
Overall trial end date
01/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/08/2005
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Germany
Trial participating centre
OrthoTrauma Evaluation Center
Mainz
D-55130
Germany
Funders
Funder type
Hospital/treatment centre
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
Basic results (scientific)
Publication list