Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain

Back Pain, Low Clinical Trial

Official title:

Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190366
• Other study ID #: Mikroaderlass
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Charite University, Berlin, Germany
• Contact: Miriam Rösner
• Phone: +49 30 80505 682
• Email: naturheilkunde.studien[@]immanuel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Low Back Pain

Intervention

Procedure:
• Bloodletting 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.
• Bloodletting 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.

Locations

Country	Name	City	State
Germany	Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Treatment adherence	Assess treatment adherence according to attendance during 3 week intervention period.	3 weeks
Other	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
Primary	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
Secondary	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
Secondary	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).	Baseline, 3 weeks, 6 weeks
Secondary	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
Secondary	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
Secondary	Change from baseline for days with pain medication use	Specific self-reported pain medication use	Baseline, 3 weeks, 6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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