Condition category
Musculoskeletal Diseases
Date applied
25/10/2009
Date assigned
17/11/2009
Last edited
09/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jan D. Rompe

ORCID ID

Contact details

OrthoTrauma Evalaution Center
Mainz
D-55130
Germany

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

Sponsor information

Organisation

OrthoTrauma Evaluation Center (Germany)

Sponsor details

Oppenheimer Str. 70
Mainz
D-55130
Germany

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes