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Evaluation of a bloodletting acupuncture at the fossa poplitea in comparison to bloodletting acupuncture at the regio glutaea and a waiting list control group in patients with subacute and chronic non-specific pain low back pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bloodletting acupuncture at the fossa poplitea | Experimental |
| |
| Bloodletting acupuncture at the regio glutaea | Experimental |
| |
| Waiting list control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloodletting acupuncture at the fossa poplitea | Procedure | This group is treated with bloodletting acupuncture at the fossa poplitea. The treatment takes place twice a week from week 1 to week 3. This means that 6 treatments of approx. 20 minutes each should be carried out within the 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average pain intensity in previous week | Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100). | Baseline, 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average pain intensity in previous week | Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100). | Baseline, 6 weeks |
| Change from baseline in average pain intensity of the last 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and treatment adherence | Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence. | 3 weeks, 6 weeks |
| Treatment adherence |
Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miriam Rösner | Contact | +49 30 80505 682 | naturheilkunde.studien@immanuel.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin | Recruiting | Berlin | 14163 | Germany |
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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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|
| Bloodletting acupuncture at the regio glutaea | Procedure | This group is treated with bloodletting acupuncture at the regio glutaea. The treatment takes place twice a week from week 1 to week 3. This means that 6 treatments of approx. 20 minutes each should be carried out within the 3 weeks. |
|
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
| Baseline, 3 weeks, 6 weeks |
| Change from baseline for back pain specific disability | Use of standardized Roland Morris Disability Questionnaire (RMDQ) to assess back pain specific disability. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 3 weeks, 6 weeks |
| Change from baseline in pain bothersomeness in previous week | Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100). | Baseline, 3 weeks, 6 weeks |
| Change from baseline for days with pain medication use | Specific self-reported pain medication use | Baseline, 3 weeks, 6 weeks |
| Change from baseline for health related quality of life | Use of standardized Short Form 36 Health Survey (SF-36). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 3 weeks, 6 weeks |
| Change from baseline for pain self-efficacy | Use of standardized Pain Self-Efficacy Questionnaire (PSEQ). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 3 weeks, 6 weeks |
| Change from baseline for anxiety and depression | Use of standardized Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 3 weeks, 6 weeks |
| Change from baseline for work productivity | Use standardized Work Productivity and Activity Impairment Questionnaire (WPAI) to assess employment status and productivity. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 3 weeks, 6 weeks |
Assess treatment adherence according to attendance during 3 week intervention period. |
| 3 weeks |
| Treatment expectation: effectiveness of bloodletting acupuncture in reducing low back pain | Assess treatment expectation at baseline, Likert scale (1-very good effectiveness to 5-poor effectiveness) | Baseline |
| D013568 |
| Pathological Conditions, Signs and Symptoms |