Plantar fasciitis - a prospective randomised multicenter study to compare functionel versus bed insole therapy
- Conditions
- Fasciitis plantaris (heel spur)M77.3Calcaneal spur
- Registration Number
- DRKS00006873
- Lead Sponsor
- KSH Campus Lübeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 131
•Willingness to wear the prescribed insoles daily for 24 weeks.
•Willingness to send back the questionnaires in the beginning of the study and after 6, 12 and 24 weeks.
•Willingness to participate in the check up and the final examination after 24 weeks.
•The patient is in legal supervision.
•The patient does not know the German language
•The patient is not willed to come in after 24 weeks to do the final examination in the clinic or practice.
•The patient is not able to walk.
•The patient is not of legal age.
•The patient is no citizen of the EU (because of possible country-specific laws only citizens of nations that belong to the European Union are included).
•Attendance of another clinical study at the same time.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After being included in the study the participants each receive a questionnaire (FADI and VAS) by mail after 6, 12 and 24 weeks. <br>In the beginning of the study the questionnaires (FADI (Foot and Ankle Disability Index), VAS and a general questionnaire) are administered by the doctor and the patients undergo a checkup and a final examination after 24 weeks, which is documented on the basis of the AOFAS (American Orthopaedic Foot and Ankle Society)-score.<br>After wearing insoles for 24 weeks, the preliminary results of each participant are documented; however, the final analysis of the results will take place once all questionnaires were submitted.<br>The main criterion of the study is the FADI-score that includes 26 questions concerning the everyday life, activities, impairment and pain, which need to be answered by the patients.<br>
- Secondary Outcome Measures
Name Time Method The participants need to fill in ten questionnaires during the study at four different points of time. First, before they wear insoles and then after 6, 12 and 24 weeks. In the beginning and at the end of the study the attending doctor additionally assigns the AOFAS-score. <br>The participating patients fill in two different questionnaires at each date of questioning: the FADI and the VAS. In the beginning, a questionnaire including general questions concerning personal data, working situation and previous therapy of the Fasciitis plantaris, needs to be answered by the patient.<br>The AOFAS- Score and the Vas are minor criterions of the study. The former is filled in by the doctor and includes questions concerning themes like pain, impairment of function, walking and position of the hinge. The Vas serves as an instrument for measuring the intensity of pain; the patient can choose between different levels e.g. not being in pain” and highest imaginable pain”.<br>