NCT05318664

Brief Summary

The shoulder joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 22, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

March 22, 2022

Last Update Submit

April 7, 2022

Conditions

Keywords

shouldercryotherapybalance

Outcome Measures

Primary Outcomes (2)

  • modified Upper Quarter Y Balance Test - mUQYBT)

    test for measuring upper extremity reach distance while in a closed-chain position

    Change from baseline to 20 minutes

  • modified Upper Quarter Y Balance Test - mUQYBT)

    test for measuring upper extremity reach distance while in a closed-chain position

    Change from baseline to 40 minutes

Secondary Outcomes (15)

  • Skin temperature

    Change from baseline to 20 minutes

  • Skin temperature

    Change from baseline to 25 minutes

  • Skin temperature

    Change from baseline to 30 minutes

  • Skin temperature

    Change from baseline to 35 minutes

  • Skin temperature

    Change from baseline to 40 minutes

  • +10 more secondary outcomes

Study Arms (2)

Cryotherapy

EXPERIMENTAL

20 minutes of cryotherapy on the dominant shoulder with ice bags

Other: Cryotherapy

Control

NO INTERVENTION

20 minutes of rest

Interventions

20 minutes of cryotherapy on the dominant shoulder with ice bags

Cryotherapy

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 28 years old
  • healthy
  • no musculoskeletal complaints

You may not qualify if:

  • failure to follow protocol
  • complaints of injury or pain during the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Carlos M Pastre

    São Paulo State University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 8, 2022

Study Start

April 25, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share