Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105579329073 Date of Approval: 17/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Wet cupping and sports performance
Official scientific title Effects of wet cupping on recovery and high-intensity performances
Brief summary describing the background and objectives of the trial Elite athletes are exposed to a high level of physical, physiological and psychological stress and therefore seek to use different strategies to gain and maintain a competitive advantage. Various strategies have been proposed in order to improve athletes’ performance and more recently the cupping therapy. When treated with suction cups, a hollow container is applied to a specific skin area and a relative vacuum is created. This depression then exerts a suction effect on the tissues on which the suction cup is placed. The vacuum effect can be created by using a suction pump or by briefly heating the inside of a glass, bamboo or other material cup with a flame. In wet cupping, incisions are made in the skin before application of the vessels and blood that appears to be stagnant, congested or containing toxins is removed from the body and sucked into suction cups. It has been reported that wet cupping therapy is able to remove pathological substances and restore normal physiology, while dry cupping therapy is based on the dilution and redistribution of these substances. There is limited scientific evidence and a lack of data especially on the use of suction cups in sports. Most studies focus on the therapeutic aspect of the suction cup and its effects for better recovery from sports injuries and not on its ability to improve sports performance. However, due to the paucity of data and methodological gaps, additional studies are needed for a conclusive judgment on the effectiveness and safety of cupping mechanisms for athletes. Thus, the aim of this study was to assess the effects of wet cupping on sleep, recovery, cognitive and short term maximum performances, repeated high-intensity performances and biological responses.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Wet cupping
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Wet cupping
Anticipated trial start date 15/04/2018
Actual trial start date
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 32
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Wet cupping Participants completed a Spiegel sleep questionnaire early and performed cognitive and physical field tests and a Wingate test starting at 10h00, a three-day rest followed by the practice of wet suction cups. Three days after, participants performed the following tests in the same time, same order and the same schedule. Each wet-cupping treatment procedure lasted about 30 min in three stages of cupping without repeating the incision. The participants practice wet cupping in the morning, they should be fasting. The process involves using glass cups to form a localized suction (negative pressure) on the skin. Heating is the process of sucking; the suction is created by heating the air inside the cup and then covering the surface of the skin through the suction barrier. Each wet-cupping treatment procedure lasted about 30 min and was conducted by the following steps (Figure2): 1. Primary aspiration: After cleaning the target area with an antiseptic product, the open flame is placed inside a glass cup, which creates an aspiration. The cup clings to the skin and was left for a period of 5 min allowing the creation of skin lifts. 2. Scarification: The cup will be removed and superficial incisions are made on the skin area limited by the impressions of the cup with sterile surgical blades for incision. 3. The cup has been replaced on the skin in order to done all three stages of cupping without repeating the incision. 4. Cleaning of application sites and covering with sterile pads. Wet cupping was performed in a specialized laboratory by a doctor. 15
Experimental Group wet cupping Participants were divided into two groups: The wet-cupping group performed two test sessions ( three 30-s Wingate tests separated by 15mn of recovery) three days before and after the wet cupping procedure . Blood samples were taken by a specialist nurse from a forearm vein after 5 minutes of sitting rest before the test session and 3 minutes after exercise to assess the biological markers. The process involves using glass cups to form localized suction (negative pressure) on the skin and lasting for about 30 minutes. Participants practice the wet suction cups in the morning, in a specialized laboratory by a doctor and they should be fasting. The process involves using glass cups to form localized suction (negative pressure) on the skin and lasting for about 30 minutes. The procedure started by cleaning the target area with an antiseptic product, the open flame is placed inside a glass cup which creates suction. The cup is attached to the skin. After 5 minutes, it will be removed and surface incisions are made on the skin area limited due to impressions with sterile surgical blades. The cup has been replaced on the skin in order to perform the three stages of cupping without repeating the incision. Each stage lasted about 7 minutes. The process ends with cleaning of application sites and covering with sterile pads. 13
Control Group without intervention The control group only performed the two test sessions: three The Wingate tests separated by 15mn of recovery. Blood samples were taken by a specialist nurse from a forearm vein after 5 minutes of sitting rest before the test session and 3 minutes after exercise to assess the biological markers. Without intervention. Without intervention 6 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Healthy physically active male - Intermediate chronotype - Tobacco addiction. - Consumption of alcoholic, caffeinated, anti-oxidant or anti-inflammatory drugs. - Practice of cupping, acupuncture, blood donation or any other therapeutic intervention during the previous six months. Adult: 19 Year-44 Year 20 Year(s) 23 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2021 the Ethics Committee of Habib Bourguiba University Hospital
Ethics Committee Address
Street address City Postal code Country
Al Firdaws street, 3027 Sfax Tunisia Sfax 3027 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Change in physical performance: the squat jump test (SJ), The Five-Jump test (5JT), the Illinois Agility Run test (ART) and the 30-s Wingate test (peak (PP) and mean (MP) powers and the fatigue index (FI)) 2- Change is sleep quality compared to baseline. The Spiegel sleep questionnaire includes six questions to judge the quality of sleep. It calculates a score that ranges from 0 to 30. The higher is the score; the better is the sleep quality. 3- Change is cognitive performances: the simple reaction time, the mental rotation test. Participants completed a first test session starting at 10h00, a three-day rest followed by the practice of wet suction cups. Three days after, they performed the following tests in the same time.
Secondary Outcome 4- Change in repeated- high- intensity performances: three Wingate tests separated by 15mn of recovery (peak (PP) and mean (MP) powers and the fatigue index (FI)). 5- .Change in biochemical parameters compared to baseline (Creatine kinase (CK), Lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), Lactate (LAC), Creatinine (CRE), Proteine-CR (CRP). 6- Change in lipid profile compared to baseline. Lipid profile (i.e. Total Cholesterol (TC), Total, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglycerides (TG)). 7- Change in Hematological parameters (NFS, RETIC, FIB). 8- Change is oxidative parameters compared to baseline (GSH, AOPP, GPX, SOD, MDA, VITc). 9- Change in mood-states. the three 30-s Wingate tests started always at 10:00 h. Blood samples were taken after 5 minutes of sitting rest before the test session and 3 minutes after exercise .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Sfax Tunisia. Airport street km 3.5 Sfax 3000 Tunisia Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Youssef Souissi Road of airport km 9, 3078 Sfax Tunisia Sfax 3078 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Higher Institute of Sport and Physical Education of Sfax airport road, km 3,5 Sfax, 3000 Tunisia Sfax 3000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Pr Zouheir Sahnoun Faculty of Medicine of Sfax, Bd Majida Boulila, Sfax 3029 Sfax 3029 Tunisia
Dr Makram Souissi Higher Institute of Sport and Physical Education of Sfax. Airport Road, Km 3,5 Sfax - 3000 Tunisia. Sfax 3000 Tunisia
Dr Mohamed Cheikh Higher Institute of Sport and Physical Education of Sfax. Airport Road, Km 3,5 Sfax - 3000 Tunisia. Sfax 3000 Tunisia
Dr Aida Elleuch Habib Bourguiba Hospital Road El Ain km 1.5 3000 Sfax Tunisia Sfax 3000 Tunisia
Pr Choumous Kallel Habib Bourguiba Hospital Road El Ain km 1.5 3000 Sfax Tunisia Sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Youssef Souissi youssef.souissi19@gmail.com 0021620902686 Airport road km 9, 3078 Sfax TUNISIA
City Postal code Country Position/Affiliation
Sfax 3078 Tunisia PhD student
Role Name Email Phone Street address
Scientific Enquiries Zouheir Sahnoun zouheir.sahnoun.fms@gmail.com00216 0021697533692 Avenue Majida BOULILA, 3029 Sfax, Tunisia
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Professor in Faculty of Medicine of Sfax
Role Name Email Phone Street address
Public Enquiries Aida Elleuch aidaelleuch@yahoo.fr 0021658128341 El Ain street km 0.5 3029 Sfax Tunisia
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Doctor in faculty of medecine de Sfax Tunisia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1- Fifteen healthy male physical education students (22±1 years, 178±8 cm, 76.1±11.4 kg; mean±SD) volunteered to participate in the study but only 13 continued testing sessions. Statistical tests were performed using STATISTICA Software (StatSoft, France). All values are expressed as mean ± Standard Deviation (mean ± SD). Following normality confirmation using the Shapiro-Wilk W-test, all mean data were analyzed using the Student’s paired samples t-test for dependent variables. 2- Eighteen active males (age: 21.17±1.1 years, height: 178.77±7.84 cm, bodymass: 77. 39±11.35 kg) divided into two groups: The wet-cupping group (WCG; n=13) and the control group (CG; n=6). the results were analysed using a three-factor repeated measures analysis of variance (ANOVA) (2 [group] × 2 [cupping] × 2 [exercise]) Witten informed consent Effects of wet suction cups on the recovery and performance of intense efforts Identification Researcher in charge of the project: Souissi Youssef E-mail address: youssef.souissi19@gmail.com Telephone: 20902686 General objective of the project The aim of this study is to assess the immediate or long-term effects of the application of wet suction cups on performance and recovery and on the kinetics of markers of oxidative stress and inflammation and biomarkers of muscle damage during exercise in active subjects. Voluntary participation Your participation in this project is voluntary. This means that you agree to participate in the project without any external constraint or pressure, and that in addition you are free to end your participation at any time during this research. Thanks, Your collaboration is important to the realization of this project and we would like to thank you. Signatures I acknowledge having read this consent form and voluntarily consent to participate in this research project. I also acknowledge that the project manager answered my questions satisfactorily. Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 monthes if i receive the registration early. All parts of the study will be published in international journals and I am sharing each publication with you after discussing the results with the reviwers. I would point out to you that the access criteria, including who can request access, will be checked. In fact, the summary results of the tests will be sent within 12 months of the end of the test.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/05/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/05/2021 Result - 06/05/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information