HealthyNCT06226961
Effects of Dynamic Cupping on Shoulder Active Range of Motion of Senior Male Handball Athletes
A study testing cupping in people with Healthy, run by University Fernando Pessoa at 1 site in Portugal.
Trial summary
The purpose of this study is to to verify the immediate effects of dynamic cupping on shoulder active range of motion (AROM) of senior male handball athletes. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cupping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Feb 2024to 23 Feb 2024
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy senior handball athletes in competition with at least three training sessions per week.
Who cannot join
- history of injury, fracture or surgical intervention in the upper limb in the last six months before the study;
- vestibular, neurological or cardiorespiratory diseases;
- reported pain in the upper limb or spine
- presence of contraindication for cupping (deep venous thrombosis, with active infection or open wound.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Dynamic Cupping on Shoulder Active Range of Motion of Senior Male Handball Athletes: A Randomized Controlled Trial
The purpose of this study is to to verify the immediate effects of dynamic cupping on shoulder active range of motion (AROM) of senior male handball athletes.
Read the detailed description
After completing the questionnaire, 80 senior male handball athletes will be randomly divided into two designated groups, Intervention Group (IG; n = 40) (dynamic cupping therapy) and Control Group (CG; n = 40) (no intervention).
Shoulder AROM (flexion, extension, abduction, adduction, horizontal adduction, horizontal abduction, internal rotation and external rotation movements) will be assessed in both control and intervention groups before (M0) and after (M1) intervention.
- Conditions
- Healthy
- Being tested
- cupping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuppingDevice
The dynamic cupping will be performed for ten minutes, at a slow pace, and consisted of applying a small amount of massage cream (ATL®) over the entire shoulder (to obtain the ideal sliding surface for cupping application), insufflation of the suction cup, with two pumps, and sliding it in the direction of the muscle fibers around the shoulder and also in the transversal direction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | For the dynamic cupping protocol, the participants will be instructed to remain seated on the massage table with their feet supported, and the technique will applied to the entire shoulder (anterior, lateral and posterior face) and surrounding muscles (upper trapezius and pectoralis major). The cupping will be performed using a plastic cupping cup (5,08 cm in diameter) (K.S. Choi Corp®) and a pistol grip hand pump (K.S. Choi Corp®). The dynamic cupping will be performed for ten minutes, at a slow pace, and consists of applying a small amount of massage cream (ATL®) over the entire shoulder (to obtain the ideal sliding surface for cupping application), insufflation of the suction cup, with two pumps, and sliding it in the direction of the muscle fibers around the shoulder and also in the transversal direction. Receives: Device: cupping |
| Control group | No intervention | Participants in the CG group will remain at rest, sitting on the massage table for 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
active movements of the shoulder
Data will be collected in two moments: baseline (M0) and after the intervention/control (M1). The shoulder range of motion will be measured using a universal goniometer.
Participants will be instructed to perform the various active movements of the shoulder on the dominant upper limb. The assessments of the shoulder flexion, extension, abduction and adduction movements will be performed standing up, controlling possible compensations. To assess abduction and horizontal adduction movements, the participants will remain seated on a massage table. Internal and external rotation movements will be assessed on a massage table in supine, without inclination. Measurements will be considered invalid if the participant is compensated with another body part. Three measures will be collected for each movement and the average of the three will be considered.
Measured: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start2 Feb 2024
- Primary completion9 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Fernando Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226961
- Sponsor's protocol ID
- FISIO-3-29072019
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Dynamic Cupping on Shoulder Active Range of Motion of Senior Male Handball Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06226961
- Acronym / sponsor ID
- FISIO-3-29072019
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Fernando PessoaUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 26 Jan 2024 (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.
The purpose of this study is to to verify the immediate effects of dynamic cupping on shoulder active range of motion (AROM) of senior male handball athletes.
Detailed description
After completing the questionnaire, 80 senior male handball athletes will be randomly divided into two designated groups, Intervention Group (IG; n = 40) (dynamic cupping therapy) and Control Group (CG; n = 40) (no intervention).
Shoulder AROM (flexion, extension, abduction, adduction, horizontal adduction, horizontal abduction, internal rotation and external rotation movements) will be assessed in both control and intervention groups before (M0) and after (M1) intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: cuppingFor the dynamic cupping protocol, the participants will be instructed to remain seated on the massage table with their feet supported, and the technique will applied to the entire shoulder (anterior, lateral and posterior face) and surrounding muscles (upper trapezius and pectoralis major). The cupping will be performed using a plastic cupping cup (5,08 cm in diameter) (K.S. Choi Corp®) and a pistol grip hand pump (K.S. Choi Corp®). The dynamic cupping will be performed for ten minutes, at a slow pace, and consists of applying a small amount of massage cream (ATL®) over the entire shoulder (to obtain the ideal sliding surface for cupping application), insufflation of the suction cup, with two pumps, and sliding it in the direction of the muscle fibers around the shoulder and also in the transversal direction. |
| Control group | No intervention | –Participants in the CG group will remain at rest, sitting on the massage table for 10 minutes. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy senior handball athletes in competition with at least three training sessions per week.
Key exclusion criteria (4 listed)
- history of injury, fracture or surgical intervention in the upper limb in the last six months before the study;
- vestibular, neurological or cardiorespiratory diseases;
- reported pain in the upper limb or spine
- presence of contraindication for cupping (deep venous thrombosis, with active infection or open wound.
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 |
|---|---|---|
| cuppingThe dynamic cupping will be performed for ten minutes, at a slow pace, and consisted of applying a small amount of massage cream (ATL®) over the entire shoulder (to obtain the ideal sliding surface for cupping application), insufflation of the suction cup, with two pumps, and sliding it in the direction of the muscle fibers around the shoulder and also in the transversal direction. | Device | Intervention group |
Primary outcome
active movements of the shoulder
Time frame: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]
Data will be collected in two moments: baseline (M0) and after the intervention/control (M1). The shoulder range of motion will be measured using a universal goniometer. Participants will be instructed to perform the various active movements of the shoulder on the dominant upper limb. The assessments of the shoulder flexion, extension, abduction and adduction movements will be performed standing up, controlling possible compensations. To assess abduction and horizontal adduction movements, the participants will remain seated on a massage table. Internal and external rotation movements will be assessed on a massage table in supine, without inclination. Measurements will be considered invalid if the participant is compensated with another body part. Three measures will be collected for each movement and the average of the three will be considered.
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 9 Apr 2024.
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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 cupping in people with Healthy, run by University Fernando Pessoa at 1 site in Portugal.
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 1 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 9 Apr 2024. 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 Portugal. 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?
active movements of the shoulder (time frame: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]). 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 9 Apr 2024.