Trial document





This trial has been registered retrospectively.
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  DRKS00006873

Trial Description

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Title

Plantar fasciitis - a prospective randomised multicenter study to compare functionel versus bed insole therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Within the scope of the clinical trial mentioned above patients that are diagnosed with calcaneal spur are randomly divided into 2 groups (á 64 patients) according to the treatment received. The data of the study’s participants is collected and analysed over a period of six month (24 weeks).

Two different kind of orthopaedic insoles are used. On the one hand there is the common soft bed insole used in conservative therapy, which damps the aching area of the heel and supports the longitudinal arch of the foot. On the other hand there is the functional insole, which ensures the stretching of the aponeurosis of the soles of the feet.

The objective of this non-commercial clinical study is to compare the two kinds of insoles and to show their clinical use. For this purpose already approved clinical evaluation scores are used (Visuelle Analogskala (VAS), Foot and Ankle Disability Index (FADI), American Orthopaedic Foot and Ankle Society- Score (AOFAS- Score)).

The evaluation is carried out in a strictly pseudonymous form under the responsibility of the orthopedic section of the Universitätsklinikum Schleswig-Holstein-Campus Lübeck.

The multicenter study is part of the insole therapy already planned. The applied insoles comply with risk class 1. Therefore the participants do not need any additional insurance.

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Brief Summary in Scientific Language

Within the scope of the clinical trial mentioned above patients that are diagnosed with calcaneal spur are randomly divided into 2 groups (á 64 patients) according to the treatment received. The data of the study’s participants is collected and analysed over a period of six month (24 weeks).

Two different kind of orthopaedic insoles are used. On the one hand there is the common soft bed insole used in conservative therapy, which damps the aching area of the heel and supports the longitudinal arch of the foot. On the other hand there is the functional insole, which ensures the stretching of the aponeurosis of the soles of the feet.

The objective of this non-commercial clinical study is to compare the two kinds of insoles and to show their clinical use. For this purpose already approved clinical evaluation scores are used (VAS, FADI-Score, AOFAS-Score).

The evaluation is carried out in a strictly pseudonymous form under the responsibility of the orthopedic section of the Universitätsklinikum Schleswig-Holstein-Campus Lübeck.

The multicenter study is part of the insole therapy already planned. The applied insoles comply with risk class 1. Therefore the participants do not need any additional insurance.

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Organizational Data

  •   DRKS00006873
  •   2015/09/16
  •   [---]*
  •   yes
  •   Approved
  •   14-252, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   Fasciitis plantaris (heel spur)
  •   M77.3 -  Calcaneal spur
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Interventions/Observational Groups

  •   soft bed insole (damps the aching area of the heel and supports the longitudinal arch of the foot) for 24 weeks
  •   functional insole (ensures the stretching of the aponeurosis of the soles of the feet) for 24 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

After being included in the study the participants each receive a questionnaire (FADI and VAS) by mail after 6, 12 and 24 weeks.
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.
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.
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.

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Secondary Outcome

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.
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.
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”.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/01/26
  •   128
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

•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.

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Exclusion Criteria

•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.

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Addresses

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    • UKSH Campus Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    •   0451-5002300
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    • Sanitätshaus Köhler
    • Industriestraße 3
    • 19386   Lübz
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    • Praxis Dr. Eckhardt Krieger
    • Mr.  Dr. med.  Henrik  Krieger 
    • Ehm-Welk-Straße 22
    • 18106  Rostock
    • Germany
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    • UKSH Campus LübeckSektion für Orthopädie
    • Ms.  Silvia  Brozat-Essen 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • UKSH Campus Lübeck, Klinik für Orthopädie und Unfallchirurgie/ Sektion für Orthopädie
    • Mr.  Prof. Dr.  M.  Russlies 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    •   0451-5002300
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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