NCT04489784

Brief Summary

Overuse injuries and painful symptoms in athletes and dancers (especially classical ballerinas) may lead to reduced functional performance. However, laser application may reduce pain and increase physical conditioning. The aim of the current study was to evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet. The hypothesis investigators was that the infrared laser would be able to reduce pain perception and enhance functional performance in ballerinas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 20, 2020

Last Update Submit

July 25, 2020

Conditions

Keywords

PainFeetBallerinas

Outcome Measures

Primary Outcomes (2)

  • Analysis of pain for feet by algometry

    Pressure pain thresholds (PPT) were assessed with an electronic algometer. The pressure was applied and the ballerinas were instructed to ask to say "stop" when the sensation changed from pressure to pain. Three PPT measurements were performed to obtain an average.

    3 months

  • Analysis of pain for feet by the visual analogue pain intensity scale

    A continuous scale comprised of a horizontal line with 10 centimeters in length was used. All ballerinas were instructed to make a mark with a pen at any point on the line between 2 verbal descriptors, one for each symptom extreme \["No pain" (score=0) and "as bad as it could be" or "worst imaginable pain" (score=10)\].

    3 months

Secondary Outcomes (2)

  • Balance Test

    3 months

  • Thermal Analysis

    3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Laser treatment on ballerina's feet.

Device: Infrared Laser

Interventions

An aluminum gallium arsenide (AlGaAs) diode laser device (Twin laser, MMOptics, São Carlos, SP, Brazil) was used. The irradiation parameters were as follows: infrared laser (808 nm wavelength) with a spot area of 0.04 cm2, and an average optical power of 100 mW operated in a continuous mode during 1 minute per point, leading to an irradiance of 2,500 mW/cm2, energy of 6 J and fluence of 125 J/cm2 per point. The laser was applied on ballerina's feet twice a week during three months.

Treatment

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Female adults who perform classical ballet training and feel pain in their foot

You may not qualify if:

  • \- The occurrence of injuries in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fernanda Rossi Paolillo

São Carlos, São Paulo, 13569600, Brazil

Location

Related Publications (4)

  • Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.

    PMID: 19731300BACKGROUND
  • Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, Bagnato VS. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018 May;38(5):785-793. doi: 10.1007/s00296-018-4000-x. Epub 2018 Feb 26.

    PMID: 29480363BACKGROUND
  • Adabbo M, Paolillo FR, Bossini PS, Rodrigues NC, Bagnato VS, Parizotto NA. Effects of Low-Level Laser Therapy Applied Before Treadmill Training on Recovery of Injured Skeletal Muscle in Wistar Rats. Photomed Laser Surg. 2016 May;34(5):187-93. doi: 10.1089/pho.2015.4031. Epub 2016 Apr 8.

    PMID: 27058781BACKGROUND
  • Shah S. Determining a young dancer's readiness for dancing on pointe. Curr Sports Med Rep. 2009 Nov-Dec;8(6):295-9. doi: 10.1249/JSR.0b013e3181c1ddf1.

    PMID: 19904068BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 28, 2020

Study Start

January 1, 2018

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No plan

Locations