Trial document




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  DRKS00004871

Trial Description

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Title

Effectiveness of leech therapy in treatment of chronic low back pain - a randomised controlled clinical study

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Trial Acronym

[---]*

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URL of the Trial

http://naturheilkunde.immanuel.de/forschung/aktuelle-studien/blutegeltherapie-bei-rueckenschmerzen.html

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Brief Summary in Lay Language

Testing the effectiveness of a single time leech therapy for chronic low back pain compared to standard back exercises

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Brief Summary in Scientific Language

open RCT
intervention
single application of 4 upt 7 leeches in paravertebral L1-S3
control:
mixed back exercise and aerobic nordic walking over 4 weeks 1 hour per week
primary outcome: Reduktion of global low back pain during the last week at day 28 +-3 messured by 100mm VAS
most importan secondary outcomes:
same VAS as above but day 56+-5, questionnaires:
SF-36, FFBH-R, SES, diary for use of pain medication

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Organizational Data

  •   DRKS00004871
  •   2013/04/26
  •   2012/04/23
  •   yes
  •   Approved
  •   11/0576 - ZS EK, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2011-004393-28 
  •   2011-004393-28  (EUCTR - European Register for Clinical Trials)
  •   4037866 
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Health Condition or Problem studied

  •   M54.5 -  Low back pain
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Interventions/Observational Groups

  •   Leeches (Hirudo verbana), single topical application of 4 to 7 animals, paravertebral L1-S3
    (leeching time interindividual variations from ca. 45 up to 90 min until leeches release by themselves)
  •   Back exercise, meaning 1 time a week 1h of mixed workout an aerobic nordic walking
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

global back pain on a 100mm VAS (visual analog scale) at day 28+-3

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Secondary Outcome

day 0:
• general patients assuming concerning effectivenes and agreeability (Likert Skala)

day 56±5:
• VAS (100 mm) painscore (backpain)

day 0, 28+-3, 56+-5:
• 100 mm VAS scoring the average disability caused by back pain during the last week
• Roland Morris Disability Questionnaire (RMDQ)
• Functionial Questionarry of Back Pain (FFbH-R)
• Quality of life SF36
• mood, depression (CES-D)
• affective pain assessment (SES)

during whole study period
•intensity/frequency of pain medication (diary)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/05/02
  •   44
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

-male and femal patient from 18 to 70 years old
-existing, specialised physician (orthopedics, neurology, pain treatment) prooved diagnosis of chronic low back pain caused by nonspecific lumbar syndrome at least since 3 months
- averaged pain intensity during the last 3 month of at least 40mm measured by VAS (visual analog scale) during pain periods on 4 out of 7 days a week

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Exclusion Criteria

-anticoagulative treatment
-anemia (Hgb in screening-lab below 12.2 g/dl bzw. 7.6 mmol/l
(women); 14.0 g/dl bzw. 8.7 mmol/l (men)
-anmenestic or laboratoric tested clotting disorder (Quick <70%, apTT >36 sec, TZ >21 sec)
-invasive spine treatment including cortocoid injection up to 6 weeks ago or sheduled for the following 8 weeks
-hemophilia
-acute hernial disc
-congenital spine disorders
-known pregnancy or lactation
-therapy by opioid-analgetics
-insulin-dependent diabetes type 1
-systemic medication by corticoids or immunisuppressives
-acute psychotic disorders
-serious comorbidity

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Addresses

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    • Charité-Universitätsmedizin Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    •   030 450
    •   [---]*
    •   [---]*
    •   [---]*
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    • Hochschulambulanz für Naturheilkunde Charité-Universitätsmedizin Berlin
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • Hochschulambulanz für Naturheilkunde Charité-Universitätsmedizin Berlin
    • Ms.  Silke  Hemmen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Hochschulambulanz für Naturheilkunde
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • Karl und Veronika Carstens Stiftung
    • Am Deimelsberg 34
    • 45276  Essen
    • Germany
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    • Biebertaler Blutegelzucht
    • Michael  Aurich 
    • Talweg 31
    • 35444  Biebertal
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.