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

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

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 Overview

• Status: Recruiting
• Conditions: Back Pain, Low
• Intervention / Treatment: Procedure: Bloodletting acupuncture at the fossa poplitea; Procedure: Bloodletting acupuncture at the regio glutaea

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Rösner; Phone Number: +49 30 80505 682; Email: naturheilkunde.studien@immanuel.de

Study Locations

• Germany
  • Berlin, Germany, 14163
    • Recruiting
    • Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
    • Contact: Miriam Rösner, Study Nurse; Phone Number: +49 (0)30 - 80505 - 682; Email: naturheilkunde.studien@immanuel.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list control group
Experimental: Bloodletting acupuncture at the fossa poplitea	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.
Experimental: Bloodletting acupuncture at the regio glutaea	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Mikroaderlass

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No