SmokingNCT04238182
Short Term Effect of Interscapular Cupping on Chest Expansion in Sedentary Male Smokers
A study testing wet cupping and dry cupping in people with Smoking, run by Cairo University at 1 site in Egypt.
Trial summary
Although cupping remains a popular treatment modality worldwide, its efficacy for most health issues has not been scientifically evaluated so further studies are needed . Claims of cardiac, vascular and respiratory protective role of inter-scapular (alkhil cupping). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- wet cupping and dry cupping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2019to 7 Feb 2020
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40 healthy sedentary male smokers.
- Body mass index of participants will range between < 30 kg/m².
- The volunteers will have no record of any cupping type, and/or other complementary and treatments in the previous 6 months.
- The volunteers with no specific causes of stress.
Who cannot join
- Alcoholic and addicted volunteers.
- Current use of anticoagulants and /or coagulopathy.
- History of chronic or acute pulmonary and cardiac diseases
- Congenital or acquired chest wall deformities.
- Apparent or any history of chest trauma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, Dokki
ali ismail, lecturer, 02 01005154209
About this study
Official title: Short Term Effect of Wet Versus Dry Cupping on Chest Expansion in Sedentary Smokers
Although cupping remains a popular treatment modality worldwide, its efficacy for most health issues has not been scientifically evaluated so further studies are needed . Claims of cardiac, vascular and respiratory protective role of inter-scapular (alkhil cupping). No studies investigated the acute effect of wet versus dry cupping - on an important cupping area like alkhil hence the importance of this study comes.
Read the detailed description
The interscapular area is used for wet cupping therapy (WCT) and was found to have special features: brown adipose tissue, immediate proximity to sympathetic ganglia, passage of the thoracic duct, two important acupuncture meridians, and proximity to the main vessel divisions carrying blood from the heart and the brain. These features indicate that the interscapular application of WCT not only discharges waste materials through a shifting of blood to the site after application of a traction force but also invigorates the body's metabolism, increases immunity, and regulates blood biochemistry, which are desired therapeutic effects of WCT.
One of known in Sunnah and in Arabic main cupping points of interscapular area is (alkahil), opposite to thoracic (T) T1-T3 scapular spine .
Prophetic medicine was our reference in selecting back points e.g. the Kahel region seems to be the most suitable point for practicing Al-hijamah for therapeutic and preventive purposes and is regarded as a common place for clearing blood coming to the skin circulation in treating many disease conditions. Kahel region is a prominent anatomical landmark and its surface marking is easy to be detected on the midline of the back at the junction of the back of the neck with the back region. Other related positions can be defined as above kahel region, below kahel region, to the right of kahel region and to the left of it.
Prophetic medicine recommended to practice Alhijamah on mainly skin over 7th cervical (C7) vertebral spine to get the maximal therapeutic benefit. Gavernorer vessel (GV) GV 14, one of the cardinal points of the governing channel, is also located next to the interscapular site on or just below the spinous process of C7. Unblocking this point, which is associated with general energy excess, may balance the functions of all body organs. Clearly, more investigations are needed to clarify every facet of activating the functions of GV cardinal points during WCT applied to the interscapular area.
Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study.
forty smoker men will be randomly selected and divided to 2 groups equal in number for each. (Group A) will receive single wet cupping session. (Group B) will receive single dry cupping session. The following points will be selected for cupping in both groups. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm. Cupping of bladder 17 will be done bilaterally.
- Conditions
- Smoking
- Being tested
- wet cupping, dry cupping
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wet cuppingOther
This smoker group will receive single wet cupping session. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm . Cupping of BL 17 will be done bilaterally.
dry cuppingOther
The smoker group will receive single dry cupping session. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm. Cupping of BL 17 will be done bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| wet cupping | Active comparator | smokers in this group will receive single wet cupping session Receives: Other: wet cupping |
| dry cupping | Active comparator | smokers in this group will receive single dry cupping session Receives: Other: dry cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
- Sitting position is usually adequate for routine measurement of blood pressure, participants will be in sitting position with back supported for 5 minutes, with arm bared , supported at the level of the heart as (denoted by the mid-sternal level), in quiet warm setting is required, no caffeine for preceding 30 minutes, question about the most recent meal or evacuation of bowels or bladder. Distended abdominal viscera cause blood pressure elevation presumably because of anxiety.
Measured: immediately after the session
oxygen saturation
by pulse oximeter
Measured: immediately after the session
Secondary outcomes (2)
heart rate
by pulse oximeter
Measured: immediately after the session
chest expansion
- The chest expansion will be taken as thoracic circumference at the end of forced inspiration minus thoracic circumference at the end of forced expiration. Two readings from upper and lower thoracic expansion will be measured at an interval of 5 minutes with the inelastic tape around the body. The averages of the two readings will be recorded. For the upper thoracic excursion (UCE), the tape measure will be placed at the level of the fifth thoracic spinous process and the third intercostal space at the midclavicular line and for the lower thoracic excursion (LCE), the tape measure will be placed at the level of the 10th thoracic spinous process and the tip of the xiphoid process. Measurements will be taken at the height of maximal inspiration and expiration and considerable care will be exercised not to pull the tape too tightly while making the measurements
Measured: immediately after the session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start2 Dec 2019
- Primary completion7 Feb 2020 (estimated)
- Study completion7 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- ali ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238182
- Sponsor's protocol ID
- P.T.REC/012/002576
- Status last verified
- Feb 2020
- First submitted
- 19 Jan 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Wet Versus Dry Cupping on Chest Expansion in Sedentary Smokers
- ClinicalTrials.gov ID
- NCT04238182
- Acronym / sponsor ID
- P.T.REC/012/002576
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 7 Feb 2020 (estimated)
- Study completion
- 7 Feb 2020 (estimated)
- First posted
- 23 Jan 2020 (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.
Although cupping remains a popular treatment modality worldwide, its efficacy for most health issues has not been scientifically evaluated so further studies are needed . Claims of cardiac, vascular and respiratory protective role of inter-scapular (alkhil cupping). No studies investigated the acute effect of wet versus dry cupping - on an important cupping area like alkhil hence the importance of this study comes.
Detailed description
The interscapular area is used for wet cupping therapy (WCT) and was found to have special features: brown adipose tissue, immediate proximity to sympathetic ganglia, passage of the thoracic duct, two important acupuncture meridians, and proximity to the main vessel divisions carrying blood from the heart and the brain. These features indicate that the interscapular application of WCT not only discharges waste materials through a shifting of blood to the site after application of a traction force but also invigorates the body's metabolism, increases immunity, and regulates blood biochemistry, which are desired therapeutic effects of WCT.
One of known in Sunnah and in Arabic main cupping points of interscapular area is (alkahil), opposite to thoracic (T) T1-T3 scapular spine .
Prophetic medicine was our reference in selecting back points e.g. the Kahel region seems to be the most suitable point for practicing Al-hijamah for therapeutic and preventive purposes and is regarded as a common place for clearing blood coming to the skin circulation in treating many disease conditions. Kahel region is a prominent anatomical landmark and its surface marking is easy to be detected on the midline of the back at the junction of the back of the neck with the back region. Other related positions can be defined as above kahel region, below kahel region, to the right of kahel region and to the left of it.
Prophetic medicine recommended to practice Alhijamah on mainly skin over 7th cervical (C7) vertebral spine to get the maximal therapeutic benefit. Gavernorer vessel (GV) GV 14, one of the cardinal points of the governing channel, is also located next to the interscapular site on or just below the spinous process of C7. Unblocking this point, which is associated with general energy excess, may balance the functions of all body organs. Clearly, more investigations are needed to clarify every facet of activating the functions of GV cardinal points during WCT applied to the interscapular area.
Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study.
forty smoker men will be randomly selected and divided to 2 groups equal in number for each. (Group A) will receive single wet cupping session. (Group B) will receive single dry cupping session. The following points will be selected for cupping in both groups. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm. Cupping of bladder 17 will be done bilaterally.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wet cupping | Active comparator | Other: wet cuppingsmokers in this group will receive single wet cupping session |
| dry cupping | Active comparator | Other: dry cuppingsmokers in this group will receive single dry cupping session |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 40 healthy sedentary male smokers.
- Body mass index of participants will range between < 30 kg/m².
- The volunteers will have no record of any cupping type, and/or other complementary and treatments in the previous 6 months.
- The volunteers with no specific causes of stress.
Key exclusion criteria (5 listed)
- Alcoholic and addicted volunteers.
- Current use of anticoagulants and /or coagulopathy.
- History of chronic or acute pulmonary and cardiac diseases
- Congenital or acquired chest wall deformities.
- Apparent or any history of chest trauma
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 |
|---|---|---|
| wet cuppingThis smoker group will receive single wet cupping session. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm . Cupping of BL 17 will be done bilaterally. | Other | wet cupping |
| dry cuppingThe smoker group will receive single dry cupping session. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm. Cupping of BL 17 will be done bilaterally. | Other | dry cupping |
Primary outcome
Blood pressure
Time frame: immediately after the session
- Sitting position is usually adequate for routine measurement of blood pressure, participants will be in sitting position with back supported for 5 minutes, with arm bared , supported at the level of the heart as (denoted by the mid-sternal level), in quiet warm setting is required, no caffeine for preceding 30 minutes, question about the most recent meal or evacuation of bowels or bladder. Distended abdominal viscera cause blood pressure elevation presumably because of anxiety.
oxygen saturation
Time frame: immediately after the session
by pulse oximeter
2 secondary outcomes
heart rate
Time frame: immediately after the session
chest expansion
Time frame: immediately after the session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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.
ali ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wet cupping and dry cupping in people with Smoking, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 5 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 6 Feb 2020. 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 Egypt. 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 ali ismail, lecturer (01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: immediately after the session). 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 6 Feb 2020.