- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489784
Infrared Laser and Classical Ballerinas' Feet
July 25, 2020 updated by: Fernanda Rossi Paolillo, University of Sao Paulo
Effects of the Infrared Laser on Classical Ballerinas' Feet
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.
Study Overview
Detailed Description
High risk of injuries and painful symptoms in athletes and dancers (especially classical ballerinas) may lead to reduced functional performance.
The use of photobiomodulation may improve functional performance in ballerinas that are affected by foot pain.
An aluminum gallium arsenide (AlGaAs) diode laser device was uded.
Infrared laser (808 nm) was applied on ballerina's feet twice a week during three months.
Thermography, algometry and unipodal static standing balance test were performed.
There were pain relief and improvement of functional performance in ballerinas.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- 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
-
-
São Paulo
-
São Carlos, São Paulo, Brazil, 13569600
- Fernanda Rossi Paolillo
-
-
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
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female adults who perform classical ballet training and feel pain in their foot
Exclusion Criteria:
- The occurrence of injuries in the last 6 months
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Laser treatment on ballerina's feet.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of pain for feet by algometry
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance Test
Time Frame: 3 months
|
Static Standing Balance Test was performed.
Ballerinas were instructed to stand on one foot to a maximum of one minute.
The time was measured in seconds.
|
3 months
|
Thermal Analysis
Time Frame: 3 months
|
Cutaneous temperatures of ballerina's feet were analyzed by thermography.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
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)
January 1, 2018
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 25, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 25, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ballet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan
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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