NCT04238182

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

January 19, 2020

Last Update Submit

February 4, 2020

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

  • 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.

    immediately after the session

  • oxygen saturation

    by pulse oximeter

    immediately after the session

Secondary Outcomes (2)

  • heart rate

    immediately after the session

  • chest expansion

    immediately after the session

Study Arms (2)

wet cupping

ACTIVE COMPARATOR

smokers in this group will receive single wet cupping session

Other: wet cupping

dry cupping

ACTIVE COMPARATOR

smokers in this group will receive single dry cupping session

Other: dry cupping

Interventions

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.

wet cupping
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.

dry cupping

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • ali ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ali ismail, lecturer

CONTACT

01005154209allooka2012@gmail.com

ahmed elfahl, lecturer

CONTACT

01001891218ahmed.elfahl@buc.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

December 2, 2019

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

EG(1)