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

OrthoTrauma Evalaution Center
Mainz
D-55130
Germany

Study information

Study designRandomised controlled observer-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffectiveness 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 objectivesNull 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) studiedPlantar fasciopathy
InterventionPatients 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 typeOther
Primary outcome measureOverall 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 measures1. 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 date01/07/2007
Completion date01/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants250
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2007
Date of final enrolment01/01/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

OrthoTrauma Evalaution Center
Mainz
D-55130
Germany

Sponsor information

OrthoTrauma Evaluation Center (Germany)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan