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

Not Applicable

• Conditions: M54.5; Low back pain

• Registration Number: DRKS00004871
• Lead Sponsor: Charité-Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-26
• Study Completion: 2015-12-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
global back pain on a 100mm VAS (visual analog scale) at day 28+-3<br>

Secondary Outcome Measures

Name	Time	Method
day 0:<br>• general patients assuming concerning effectivenes and agreeability (Likert Skala) <br><br>day 56±5:<br>• VAS (100 mm) painscore (backpain)<br> <br>day 0, 28+-3, 56+-5:<br>• 100 mm VAS scoring the average disability caused by back pain during the last week <br>• Roland Morris Disability Questionnaire (RMDQ)<br>• Functionial Questionarry of Back Pain (FFbH-R)<br>• Quality of life SF36 <br>• mood, depression (CES-D)<br>• affective pain assessment (SES)<br><br>during whole study period<br>•intensity/frequency of pain medication (diary)