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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-Nr. 2006-006390-24 |
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| Name | Class |
|---|---|
| WALA Heilmittel GmbH | OTHER |
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The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Disci/Rhus toxicodendron comp.® |
|
| 2 | Placebo Comparator | placebo solution |
|
| 3 | No Intervention | waiting list group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disci/Rhus toxicodendron comp.® | Drug | s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (0-100 mm) low back pain | once after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Back function (back function scale FFbHR) | once at week 8 and 26 | |
| visual analogue scale (0-100 mm) low back pain | once after week 26 | |
| days with medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Witt, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22087222 | Result | Pach D, Brinkhaus B, Roll S, Wegscheider K, Icke K, Willich SN, Witt CM. Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial. PLoS One. 2011;6(11):e26166. doi: 10.1371/journal.pone.0026166. Epub 2011 Nov 8. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| placebo solution | Drug | s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks |
|
| week 4 to 8 |
| quality of life (SF-36) | once at week 8 and 26 |
| pain disability scale (PDI) | once at week 8 and 26 |
| emotional pain scale (SES) | once at week 8 and 26 |
| influence of patient expectancy | once at week 8 and 26 |
| influence of physician expectancy | once at week 8 and 26 |
| Responder rate 36% VAS pain intensity | once at week 8 and 26 |
| numbers of days with absence from work | between week 4 and 8 |
| days with physician visits because of low back pain | between week 4 and 8 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |