Effectives of leech therapy

Conditions: chronic low back pain-diagnosis assured by specialist (orthopedy, neurology, pain therapy) as chronic low back pain for at least 3 month caused by nonspecific lumbar syndrome- averaged pain intensity during the last 3 month of at least 40mm measured by VAS (visual analog scale) during pain periodson 4 out of 7 days a week
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-004393-28-DE

Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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
-acute hernial disc
-congenital spine disorders
-known pregnancy
-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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Changes in the VAS (100mm) pain score 7 days after leech treatment<br>;Secondary Objective: -100mm VAS concerning back pain after 56 +-5 days<br>-100 mm VAS concerning global disability caused by back pain<br>-Roland Morris Disability Score<br>-FFbH-R<br>-SF-36<br>-general assesment of patient antiception concerning the efforts of the therapy (Likert-scale)<br>-CES-D<br>-SES<br>-diary of analgetics consumption<br>-checking agreability by asking for serious adverse events (SAEs)<br>;Primary end point(s): Change in pain intensity on the VAS from baseline to day 7 +-1;Timepoint(s) of evaluation of this end point: 7 +- 1 day

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 7 +-1 days an 56 +-5 days;Secondary end point(s): Changes in values of function, pain, mood, quality of life assement inventories such as Rolland-Morris, SF 36 and others