NCT04688892

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

December 11, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5 days

First QC Date

December 3, 2020

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in elbow extension range of motion

    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).

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

The participants will remain at rest in a supine position on a massage table (Posturarte® Olympic) without inclination for 5 minutes.

Interventions

CuppingDEVICE

dynamic cupping

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ricardo Cardoso

Porto, 4200-253 Porto, Portugal

Location

MeSH Terms

Interventions

Cupping Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ricardo Cardoso, PhD

    Fernando Pessoa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 30, 2020

Study Start

December 11, 2020

Primary Completion

December 16, 2020

Study Completion

December 30, 2020

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations