Chronic PainNCT05392283
Vacuum Cupping for Chronic Neck and Back Pain
A study testing AERO vacuum cupping device in people with Chronic Pain and Neck Pain, run by Jena University Hospital at 1 site in Germany.
Trial summary
Small clinical pilot studies have shown that vacuum massage-related techniques such as traditional dry cupping can reduce musculoskeletal pain such as back and neck pain. At the same time, little is yet known about the potential mechanisms of action of these therapies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Neck Pain, Back Pain
- What is being tested?
- AERO vacuum cupping device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2022to 30 Aug 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic neck or back pain
- mean pain intensity ≥ 40 mm VAS
Who cannot join
- neurological symptoms or neuropathic pain
- vertebral column surgery less than 12 months prior to the study
- TENS, acupuncture, osteopathy, or a chiropractic maneuvre or infiltration at the area within 4 weeks prior to the inclusion in the study
- congenital deformation of the spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vacuum Cupping for Chronic Neck and Back Pain - a Feasibility Study
Small clinical pilot studies have shown that vacuum massage-related techniques such as traditional dry cupping can reduce musculoskeletal pain such as back and neck pain. At the same time, little is yet known about the potential mechanisms of action of these therapies. A vacuum pump induces a massaging effect of the skin including the deeper tissue layers. The resulting massage technique corresponds to a kind of tissue manipulation similar to dry cupping. In this procedure, suction force and air flow can be individually adjusted. This is an advantage that can be used for patients with varying degrees of sensitivity or who are preloaded by patients with varying degrees of sensitivity or a history of pain. The aim of this study was to test the feasibility of the study design.
- Conditions
- Chronic Pain, Neck Pain, Back Pain
- Being tested
- AERO vacuum cupping device
- Keywords
- Vacuum cupping, Quantitative sensory testing
- Medical subject headings
- Chronic Pain, Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERO vacuum cupping deviceDevice
The treatment consists of 5 sessions (approx. 30 min) of vacuum massage. The vacuum pump provided by the device provides a type of vacuum massage, that can be adjusted according to applied suction and air flow. The resulting massage technique provides a type of soft tissue manipulation similar to the ancient traditional medicine technique of cupping. Nonetheless, this automated technique allows for more precise determination of the massage characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum cupping | Experimental | Not described Receives: Device: AERO vacuum cupping device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Numeric rating scale (NRS))
NRS is a 11-point pain scale for self-reporting of pain ("0" meaning "no pain" and "10" meaning "worst pain")
Measured: measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Secondary outcomes (4)
Quantitative sensory testing (QST)
QST is a diagnostic tool which allows measurement of pain sensitivity.
Measured: measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Neck Disability Index (NDI)
NDI is used to measure neck pain and to quantify disability for neck pain.
Measured: measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatmentekly during treatment (week 2 to 5) and 1 month after last treatment
Oswestry Disability Index (ODI)
ODI is used to measure low back pain and to quantify disability for low back pain.
Measured: measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatment
Pain diary
A pain diary helps to track pain in the course of the study.
Measured: filled in from baseline (week 1) until last treatment (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start2 May 2022
- Primary completion31 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena, Helheten Norway, National Research Centre of Complementary and Alternative Medicine, Norway
- Responsible party
- Principal investigator, Winfried Meißner, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392283
- Sponsor's protocol ID
- VC2022-1.0
- Status last verified
- Feb 2025
- First submitted
- 26 Apr 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Cupping for Chronic Neck and Back Pain - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05392283
- Acronym / sponsor ID
- VC2022-1.0
- Conditions
- Chronic Pain, Neck Pain, Back Pain
- Keywords
- Vacuum cupping, Quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- University of Jena, Helheten Norway, National Research Centre of Complementary and Alternative Medicine, Norway
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 26 May 2022 (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.
Small clinical pilot studies have shown that vacuum massage-related techniques such as traditional dry cupping can reduce musculoskeletal pain such as back and neck pain. At the same time, little is yet known about the potential mechanisms of action of these therapies. A vacuum pump induces a massaging effect of the skin including the deeper tissue layers. The resulting massage technique corresponds to a kind of tissue manipulation similar to dry cupping. In this procedure, suction force and air flow can be individually adjusted. This is an advantage that can be used for patients with varying degrees of sensitivity or who are preloaded by patients with varying degrees of sensitivity or a history of pain. The aim of this study was to test the feasibility of the study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vacuum cupping | Experimental | Device: AERO vacuum cupping device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic neck or back pain
- mean pain intensity ≥ 40 mm VAS
Key exclusion criteria (4 listed)
- neurological symptoms or neuropathic pain
- vertebral column surgery less than 12 months prior to the study
- TENS, acupuncture, osteopathy, or a chiropractic maneuvre or infiltration at the area within 4 weeks prior to the inclusion in the study
- congenital deformation of the spine
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 |
|---|---|---|
| AERO vacuum cupping deviceThe treatment consists of 5 sessions (approx. 30 min) of vacuum massage. The vacuum pump provided by the device provides a type of vacuum massage, that can be adjusted according to applied suction and air flow. The resulting massage technique provides a type of soft tissue manipulation similar to the ancient traditional medicine technique of cupping. Nonetheless, this automated technique allows for more precise determination of the massage characteristics. | Device | Vacuum cupping |
Primary outcome
Pain intensity (Numeric rating scale (NRS))
Time frame: measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
NRS is a 11-point pain scale for self-reporting of pain ("0" meaning "no pain" and "10" meaning "worst pain")
4 secondary outcomes
Quantitative sensory testing (QST)
Time frame: measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Neck Disability Index (NDI)
Time frame: measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatmentekly during treatment (week 2 to 5) and 1 month after last treatment
Oswestry Disability Index (ODI)
Time frame: measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatment
Pain diary
Time frame: filled in from baseline (week 1) until last treatment (week 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AERO vacuum cupping device in people with Chronic Pain and Neck Pain, run by Jena University Hospital 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 4 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: finished, as of the sponsor's last update on 28 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Numeric rating scale (NRS)) (time frame: measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment). 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 28 Feb 2025.