PainNCT04489784
Infrared Laser and Classical Ballerinas' Feet
A study testing Infrared Laser in people with Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Infrared Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female adults who perform classical ballet training and feel pain in their foot
Who cannot join
- The occurrence of injuries in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Infrared Laser
- Keywords
- Pain, Feet, Ballerinas
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Laser treatment on ballerina's feet. Receives: Device: Infrared Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)].
Measured: 3 months
Secondary outcomes (2)
Balance Test
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.
Measured: 3 months
Thermal Analysis
Cutaneous temperatures of ballerina's feet were analyzed by thermography.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jan 2018
- Primary completion1 Mar 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Rossi Paolillo, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489784
- Sponsor's protocol ID
- Ballet
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
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.
PubMed 19731300Paolillo 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.
PubMed 29480363Adabbo 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.
PubMed 27058781Shah 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.
PubMed 19904068
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Infrared Laser on Classical Ballerinas' Feet
- ClinicalTrials.gov ID
- NCT04489784
- Acronym / sponsor ID
- Ballet
- Conditions
- Pain
- Keywords
- Pain, Feet, Ballerinas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Infrared LaserLaser treatment on ballerina's feet. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female adults who perform classical ballet training and feel pain in their foot
Key exclusion criteria (1 listed)
- The occurrence of injuries in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared LaserAn 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. | Device | Treatment |
Primary outcome
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.
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)].
2 secondary outcomes
Balance Test
Time frame: 3 months
Thermal Analysis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 19731300Leal 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.
- Background: PubMed 29480363Paolillo 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.
- Background: PubMed 27058781Adabbo 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.
- Background: PubMed 19904068Shah 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.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared Laser in people with Pain, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of pain for feet by algometry (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489784, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.