Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain
- Conditions
- Back Pain, Low
- Interventions
- Procedure: Bloodletting acupuncture at the fossa popliteaProcedure: Bloodletting acupuncture at the regio glutaea
- Registration Number
- NCT06190366
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
- Specialist confirmed diagnosis of subacute or chronic non-specific low back pain for at least 6 weeks prior to inclusion
- Average pain intensity with at least 50 mm on the VAS from 0 to 100 mm
Exclusion criteria:
- Serious illnesses
- Poor general condition
- Coagulation disorder, therapy with anticoagulants
- Thrombophlebitis, skin inflammation in the area of the lower extremities
- Alcohol, drug or medication addiction
- Pregnancy
- Lack of willingness to cooperate, linguistically or mentally unable to understand the contents of the study
- Participation in another clinical trial during the study period
- Starting a new therapy for the treatment of low back pain in the last 2 weeks
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bloodletting acupuncture at the fossa poplitea Bloodletting acupuncture at the fossa poplitea - Bloodletting acupuncture at the regio glutaea Bloodletting acupuncture at the regio glutaea -
- Primary Outcome Measures
Name Time Method Change from baseline in average pain intensity in previous week Baseline, 3 weeks Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
- Secondary Outcome Measures
Name Time Method Change from baseline for days with pain medication use Baseline, 3 weeks, 6 weeks Specific self-reported pain medication use
Change from baseline in average pain intensity in previous week Baseline, 6 weeks Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Change from baseline in average pain intensity of the last 24 hours Baseline, 3 weeks, 6 weeks Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Change from baseline for back pain specific disability Baseline, 3 weeks, 6 weeks 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.
Change from baseline in pain bothersomeness in previous week Baseline, 3 weeks, 6 weeks Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100).
Change from baseline for health related quality of life Baseline, 3 weeks, 6 weeks 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.
Change from baseline for pain self-efficacy Baseline, 3 weeks, 6 weeks 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.
Change from baseline for work productivity Baseline, 3 weeks, 6 weeks 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.
Change from baseline for anxiety and depression Baseline, 3 weeks, 6 weeks 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.
Trial Locations
- Locations (1)
Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
🇩🇪Berlin, Germany