Condition category
Musculoskeletal Diseases
Date applied
23/11/2009
Date assigned
03/12/2009
Last edited
03/12/2009
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 Evaluation Center
Oppenheimer Str. 70
Mainz
D-55130
Germany

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 measures

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

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 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

01/08/2005

Recruitment end date

01/08/2008

Locations

Countries of recruitment

Germany

Trial participating centre

OrthoTrauma Evaluation Center
Mainz
D-55130
Germany

Sponsor information

Organisation

OrthoTrauma Evaluation Centre (Germany)

Sponsor details

Oppenheimer Str. 70
Mainz
D-55130
Germany

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes