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

NCT ID: NCT06190366

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Back Pain, Low

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bloodletting acupuncture at the fossa poplitea

Group Type EXPERIMENTAL

Bloodletting acupuncture at the fossa poplitea

Intervention Type 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 regio glutaea

Group Type EXPERIMENTAL

Bloodletting acupuncture at the regio glutaea

Intervention Type 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.

Waiting list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andreas Michalsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Miriam Rösner

Role: CONTACT

+49 30 80505 682

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Miriam Rösner, Study Nurse

Role: primary

+49 (0)30 - 80505 - 682

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mikroaderlass

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acupuncture and Pain Processing
NCT01270607 COMPLETED NA