Back Pain, Low
Conditions
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.
Interventions
PROCEDUREBloodletting acupuncture at the fossa poplitea
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.
PROCEDUREBloodletting acupuncture at the regio glutaea
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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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 for days with pain medication use | Baseline, 3 weeks, 6 weeks | Specific self-reported pain medication use |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment expectation: effectiveness of bloodletting acupuncture in reducing low back pain | Baseline | Assess treatment expectation at baseline, Likert scale (1-very good effectiveness to 5-poor effectiveness) |
| Number of participants with adverse events as a measure of safety and treatment adherence | 3 weeks, 6 weeks | Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence. |
| Treatment adherence | 3 weeks | Assess treatment adherence according to attendance during 3 week intervention period. |
Countries
Germany
Contacts
Primary ContactMiriam Rösner
Outcome results
None listed