NCT02327988

Brief Summary

This study propose investigate the effect of cryotherapy and laser therapy in response to strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms). All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise), composed of pain sensation, measure of the strength and muscle activation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

December 11, 2014

Last Update Submit

December 25, 2014

Conditions

Keywords

cryotherapylaser therapyeccentric exercisedelayed onset muscle sorenessmuscle damagedynamometryelectromyography

Outcome Measures

Primary Outcomes (1)

  • Pain sensation

    Through the VAS (visual analogue scale).

    Within the first 3 days

Secondary Outcomes (2)

  • Strength

    Within the first 3 days

  • Muscle activation

    Within the first 3 days

Study Arms (3)

Cryotherapy

EXPERIMENTAL

To the cryotherapy group a 1kg ice pack was strapped over the entire brachial biceps muscle and adjacent muscles of the arm under study using a bandage, and the application lasted 25 minute laser

Other: Cryotherapy

Laser therapy

EXPERIMENTAL

The laser therapy group received laser application to the muscle belly of the non-dominant upper limb brachial biceps at four different points.

Device: Laser therapy

Control

NO INTERVENTION

The control group did not undergo any intervention and remained at rest for 25 minutes.

Interventions

Cryotherapy
Laser therapy

Eligibility Criteria

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

You may qualify if:

  • Female sex
  • Aged between 18 and 28 years
  • Healthy, considered active according to the International Physical Activity Questionnaire -Short Form (IPAQ)
  • Engaging in physical activity involving upper limbs at least 2 times a week
  • Exhibiting shoulder joint, elbow and non-dominant hand integrity
  • Not having a history of osteo-myoarticular injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments.
  • Furthermore they could not be allergic to ice (verified by the ice cube test) or any absolute contraindication for the use of laser (cancer and pregnancy).

You may not qualify if:

  • Not understanding the commands given in the protocols and/or inadequate performance during assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CryotherapyLaser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jamilson Simões Brasileiro

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 31, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 31, 2014

Record last verified: 2014-12