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 periods on 4 out of 7 days a week
Conditions
Interventions
Trade Name: Medirud®Biebertal
Product Name: Medirud®Biebertal
Pharmaceutical Form: Living tissue equivalent
INN or Proposed INN: Hirudo verbana
Current Sponsor code: 06-2011
Other descriptive name:
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes in the VAS (100mm) pain score 7 days after leech treatment ;Secondary Objective: -100mm VAS concerning back pain after 56 +-5 days -100 mm VAS concerning global disability caused by back pain -Roland Morris Disability Score -FFbH-R -SF-36 -general assesment of patient antiception concerning the efforts of the therapy (Likert-scale) -CES-D -SES -diary of analgetics consumption -checking agreability by asking for serious adverse events (SAEs) ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactAbteilung für Naturheilkunde
Charité Universitätsmedizin Berlin
Outcome results
None listed