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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
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.
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.
Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
Berlin, Germany
RECRUITINGChange 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).
Time frame: Baseline, 3 weeks
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).
Time frame: Baseline, 6 weeks
Change from baseline in average pain intensity of the last 24 hours
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for days with pain medication use
Specific self-reported pain medication use
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 weeks, 6 weeks