Oxygen MetabolismNCT03816787
Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain
A study testing Negative pressure therapy in people with Oxygen Metabolism and Muscle Spasticity, run by Chinese Academy of Medical Sciences.
Trial summary
This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Metabolism, Muscle Spasticity
- What is being tested?
- Negative pressure therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 29 May 2021
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have had non-specific low back pains at least 12 weeks now.
- Healthy people who are interested in dry cupping therapy
Who cannot join
- Patients who have had non-specific low back pains at least 12 weeks now.
- Healthy people who are interested in dry cupping therapy
- Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
- Patients who are inappropriate to the wet cupping treatment.
- AIDS, Active Hepatitis, Tuberculosis, Syphilis
- Patients who regularly take anticoagulants, antiplatelet drugs
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- Anemia, thrombocytopenia
- Hemorrhagic disease like hemophilia
- Diabetes
- Severe cardiovascular disease
- Kidney diseases (renal failure, chronic renal disease)
- Patients who have experiences of wet cupping treatment during last 3 months.
- Patients who have had treatment for low back pain during last 2 weeks.
- Patients who are in pregnancy or have plan to conception.
- Patients who have vertebra surgery or have plan of surgery.
- Patients who are inappropriate to join this trial judged by the radiologists or specialists.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]) and the derived change in blood volume ([tHb]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.
- Conditions
- Oxygen Metabolism, Muscle Spasticity
- Being tested
- Negative pressure therapy
- Keywords
- Cupping Therapy, Near Infrared Spectroscopy
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure therapyProcedure or surgery
Also called Dry cupping therapy
Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| dry cupping for patients of low back pain | Experimental | Patients will receive four consecutive dry cupping therapy application in one month. Receives: Procedure: Negative pressure therapy |
| dry cupping for health people | Active comparator | Health people will receive four consecutive dry cupping therapy application in one month. Receives: Procedure: Negative pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ[HbO2]
the concentration changes of oxyhemoglobin (higher alternation means better curative effect)
Measured: all groups: up to 4 weeks
Δ[Hb]
the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)
Measured: all groups: up to 4 weeks
Secondary outcomes (2)
Δ[tHb]
the concentration changes of blood volume (higher alternation means better curative effect)
Measured: all groups: up to 4 weeks
NRS
Numeric Rating Scale for pain (lower score means better curative effect)
Measured: experimental group: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Dec 2019 (estimated)
- Primary completion25 Nov 2020 (estimated)
- Study completion29 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen MetabolismStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Li, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816787
- Sponsor's protocol ID
- NIRS for Cupping Therapy
- Status last verified
- Jul 2019
- First submitted
- 20 Jan 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain
- ClinicalTrials.gov ID
- NCT03816787
- Acronym / sponsor ID
- NIRS for Cupping Therapy
- Conditions
- Oxygen Metabolism, Muscle Spasticity
- Keywords
- Cupping Therapy, Near Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 25 Nov 2020 (estimated)
- Study completion
- 29 May 2021 (estimated)
- First posted
- 25 Jan 2019 (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.
This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]) and the derived change in blood volume ([tHb]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry cupping for patients of low back pain | Experimental | Procedure: Negative pressure therapyPatients will receive four consecutive dry cupping therapy application in one month. |
| dry cupping for health people | Active comparator | Procedure: Negative pressure therapyHealth people will receive four consecutive dry cupping therapy application in one month. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who have had non-specific low back pains at least 12 weeks now.
- Healthy people who are interested in dry cupping therapy
Key exclusion criteria (16 listed)
- Patients who have had non-specific low back pains at least 12 weeks now.
- Healthy people who are interested in dry cupping therapy
- Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
- Patients who are inappropriate to the wet cupping treatment.
- Patients who have experiences of wet cupping treatment during last 3 months.
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 |
|---|---|---|
| Negative pressure therapyAlso: Dry cupping therapyParticipants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks | Procedure or surgery | dry cupping for health people, dry cupping for patients of low back pain |
Primary outcome
Δ[HbO2]
Time frame: all groups: up to 4 weeks
the concentration changes of oxyhemoglobin (higher alternation means better curative effect)
Δ[Hb]
Time frame: all groups: up to 4 weeks
the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)
2 secondary outcomes
Δ[tHb]
Time frame: all groups: up to 4 weeks
NRS
Time frame: experimental group: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Significant and sustaining elevation of blood oxygen induced by Chinese cupping therapy as assessed by near-infrared spectroscopyLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure therapy in people with Oxygen Metabolism and Muscle Spasticity, run by Chinese Academy of Medical Sciences.
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 16 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ting Li (18002127296, t.li619@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ[HbO2] (time frame: all groups: up to 4 weeks). The study lists 2 primary outcomes in all. 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 24 Jul 2019.