Immediate Effects of Dynamic Cupping on Median Nerve's Mechanosensitivity

September 20, 2021 updated by: Ricardo Cardoso, University Fernando Pessoa

Immediate Effects of Dynamic Cupping on Median Nerve's Mechanosensitivity, Measured by the Upper Limb Neurodynamic Test 1 (ULNT1) in Healthy Participants: A Randomized Controlled Trial

The purpose oh this study is to verify the immediate effects of dynamic cupping on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After completing the socio-demographic and clinical questionnaire, the participants will be randomly assigned into two designated groups, the Intervention Group (IG; n = 30) (dynamic cupping therapy throughout the median nerve course) and the Control Group (CG; n = 30) (remained at rest for 5 minutes), using the software www.graphpad.com/quickcals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-253 Porto
        • Ricardo Cardoso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Healthy university students of both genders with normal mobility of the joints of the upper quadrant of the body.

Exclusion Criteria:

  • Deformities in the upper quadrant region of the body;
  • Complaints in this region in the last 6 months;
  • Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies of the upper quadrant that may disturb nerve function;
  • Not present any mechanosensitive response to ULNT1;
  • Pregnant women;
  • Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Intervention Group
The type of cupping therapy will be dry-cupping with moving-cupping (dynamic cupping therapy). The participants will remain in the supine position on a massage table (Posturarte® Olympic), without inclination. Cupping therapy will be performed with a plastic suction cup (5.08 cm in diameter) (K.S. Choi Corp®) and with a pistol for dosing pumps (K.S. Choi Corp®). Prior to the cupping therapy, a small amount of massage cream (ATL®) will be applied throughout the median nerve pathway in order to facilitate the sliding of the suction cup. The cupping therapy will performed with the suction cup sliding with a slow rhythm, insufflation of the suction cup with two pumps for 5 minutes along the median nerve path.
Device: Cupping
dynamic cupping
NO_INTERVENTION: Control Group
The participants will remain at rest in a supine position on a massage table (Posturarte® Olympic) without inclination for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in elbow extension range of motion
Time Frame: Baseline (M0), Immediately after intervention or control (M1).

Data will be collected in two moments: baseline (M0) and after the application of cupping for intervention group or after a resting period for control group (M1).

The M0 will consist in performing the ULNT1 on the dominant upper limb for each participant. The participants will remain in a supine position on a massage table with the body aligned, exposing the test forearm for the placement of the smartphone through an armband. The head and cervical spine will be stabilized at the maximum comfortable lateral inclination using a foam pillow. The ULNT1 sequence used was: (1) maximum contralateral cervical inclination; (2) arm at 90º of shoulder abduction preventing scapular elevation; (3) 90º of external rotation of the shoulder and elbow flexion at 90º (defined as the initial position or 0º of range of motion under test); (4) supination of the forearm; (5) wrist and fingers extension; and (6) elbow extension.
Baseline (M0), Immediately after intervention or control (M1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Fernando Pessoa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FISIO-1-28102019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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