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
Protocol serial number	N/A
Sponsor	OrthoTrauma Evaluation Center (Germany)
Funder	OrthoTrauma Evaluation Center (Germany)

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

Primary study design	Interventional
Study design	Randomised controlled observer-blinded trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes