Back Pain, LowNCT06190366
Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain
A study testing Bloodletting acupuncture at the fossa poplitea and Bloodletting acupuncture at the regio glutaea in people with Back Pain, Low, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain, Low
- What is being tested?
- Bloodletting acupuncture at the fossa poplitea and Bloodletting acupuncture at the regio glutaea
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
Berlin, 14163
Miriam Rösner, Study Nurse, +49 (0)30 - 80505 - 682, naturheilkunde.studien@immanuel.de
About this study
Official title: 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.
- Conditions
- Back Pain, Low
- Being tested
- Bloodletting acupuncture at the fossa poplitea, Bloodletting acupuncture at the regio glutaea
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloodletting acupuncture at the fossa popliteaProcedure or surgery
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 glutaeaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bloodletting acupuncture at the fossa poplitea | Experimental | Not described Receives: Procedure: Bloodletting acupuncture at the fossa poplitea |
| Bloodletting acupuncture at the regio glutaea | Experimental | Not described Receives: Procedure: Bloodletting acupuncture at the regio glutaea |
| Waiting list control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 weeks
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, 3 weeks, 6 weeks
Change from baseline for days with pain medication use
Specific self-reported pain medication use
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start19 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190366
- Sponsor's protocol ID
- Mikroaderlass
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06190366
- Acronym / sponsor ID
- Mikroaderlass
- Conditions
- Back Pain, Low
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bloodletting acupuncture at the fossa popliteaThis 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. | Procedure or surgery | Bloodletting acupuncture at the fossa poplitea |
| Bloodletting acupuncture at the regio glutaeaThis 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. | Procedure or surgery | Bloodletting acupuncture at the regio glutaea |
Primary outcome
Change from baseline in average pain intensity in previous week
Time frame: Baseline, 3 weeks
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
9 secondary outcomes
Change from baseline in average pain intensity in previous week
Time frame: Baseline, 6 weeks
Change from baseline in average pain intensity of the last 24 hours
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for back pain specific disability
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline in pain bothersomeness in previous week
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for days with pain medication use
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for health related quality of life
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for pain self-efficacy
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for anxiety and depression
Time frame: Baseline, 3 weeks, 6 weeks
Change from baseline for work productivity
Time frame: Baseline, 3 weeks, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloodletting acupuncture at the fossa poplitea and Bloodletting acupuncture at the regio glutaea in people with Back Pain, Low, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Rösner (+49 30 80505 682, naturheilkunde.studien@immanuel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in average pain intensity in previous week (time frame: Baseline, 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.