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

NCT06190366 | Unknown

• 1 other identifier: Mikroaderlass
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain, Low

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline in average pain intensity in previous week

  Baseline, 6 weeks

• Change from baseline in average pain intensity of the last 24 hours

  Baseline, 3 weeks, 6 weeks

• Change from baseline for back pain specific disability

  Baseline, 3 weeks, 6 weeks

• Change from baseline in pain bothersomeness in previous week

  Baseline, 3 weeks, 6 weeks

• Change from baseline for days with pain medication use

  Baseline, 3 weeks, 6 weeks

Other Outcomes (3)

• Number of participants with adverse events as a measure of safety and treatment adherence

  3 weeks, 6 weeks

• Treatment adherence

  3 weeks

• Treatment expectation: effectiveness of bloodletting acupuncture in reducing low back pain

  Baseline

Study Arms (3)

Bloodletting acupuncture at the fossa poplitea

EXPERIMENTAL

Procedure: Bloodletting acupuncture at the fossa poplitea

Bloodletting acupuncture at the regio glutaea

EXPERIMENTAL

Procedure: Bloodletting acupuncture at the regio glutaea

Waiting list control group

NO INTERVENTION

Interventions

Bloodletting acupuncture at the fossa poplitea PROCEDURE

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 fossa poplitea

Bloodletting acupuncture at the regio glutaea PROCEDURE

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.

Bloodletting acupuncture at the regio glutaea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Average pain intensity with at least 50 mm on the VAS from 0 to 100 mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

Berlin, 14163, Germany

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Miriam Rösner

CONTACT

+49 30 80505 682; naturheilkunde.studien@immanuel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: December 19, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)