Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery

NCT ID: NCT02622971

Last Updated: 2016-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-01-31

Brief Summary

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Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric test in isokinetic dynamometer to measure muscle function). After, volunteers performed the exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS measure and MVC test were repeated. The treatments according to randomisation were performed three minutes after exercise protocol and it were performed again in 24, 48, 72h after eccentric exercise.

The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1 hour, 24, 48, 72 and 96 hours after exercise protocol).

Detailed Description

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A randomized, double-blind, placebo-controlled clinical trial was performed at the Laboratory of Phototherapy in Sport and Exercise at Nove de Julho University in the city of São Paulo, Brazil.

Fifty healthy untrained male subjects were recruited from university staff and students to participate in the study. All participants voluntarily must agree to participate and they signed the informed consent statement. The intention-to-treat analysis was followed.

The volunteers were randomly allocated to five experimental groups (n=10 per group) according to the applied comparator. Randomisation was carried out by a simple drawing of lots (A, B, C, D or E). Blood samples (10 ml) was taken by a qualified nurse to analyse CK activity posteriorly. This blood collection was repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after eccentric protocol.

A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher. DOMS assessments were performed at baseline, immediately after eccentric exercise protocol (1 minute), and it was repeated at 1, 24, 48, 72 and 96 hours after the exercise protocol. Before exercise protocol, volunteers will perform a stretching and warm-up of the non-dominant lower limb and then they will perform Maximum voluntary contraction (MVC) to evaluate muscle function. MVC measurements were repeated at the same time intervals as the CK measures.

The exercise protocol consists in 75 eccentric isokinetic contractions of the knee extensor musculature in the non-dominant leg (5 sets of 15 repetitions, 30-second rest interval between sets) at a velocity of 60°.seg-1 in both the eccentric and concentric movements with a 60° range of motion (between 90° and 30° of knee flexion).

Regarding to treatment, all volunteers received the treatment according to randomisation three minutes after eccentric exercise protocol. Comparators were repeated at 24, 48, and 72 hours following the collection of additional blood samples for CK analyses and MVC and DOMS assessments.

The five groups was divided in: PBMT (photobiomodulation therapy)+cryotherapy; cryotherapy+PBMT; active PBMT; placebo PBMT and only cryotherapy.

PBMT was applied employing a cordless, portable GameDay™ Super Pulsed Laser (manufactured by Multi Radiance Medical, USA) to 6 sites of quadriceps femoris in direct contact with the skin (2 centrally - rectus femoral and vastus intermedius; 2 laterally - vastus lateralis; and 2 medially - vastus medialis) and cryotherapy was done with two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) that will cover the entire quadriceps for 20 minutes.

Conditions

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Post-exercise Muscle Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PBMT and Cryotherapy

Volunteers allocated in this group received phototherapy (PBMT - applied in six points of quadriceps) and cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol.

Group Type ACTIVE_COMPARATOR

PBMT

Intervention Type OTHER

Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.

Cryotherapy

Intervention Type OTHER

Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.

Cryotherapy and PBMT

Volunteers allocated in this group received cryotherapy (20 minutes in PRICE protocol) and phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol.

Group Type ACTIVE_COMPARATOR

PBMT

Intervention Type OTHER

Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.

Cryotherapy

Intervention Type OTHER

Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.

PBMT (active phototherapy)

Volunteers allocated in this group received active phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol.

Group Type ACTIVE_COMPARATOR

PBMT

Intervention Type OTHER

Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.

PBMT (placebo phototherapy)

Volunteers allocated in this group received placebo phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. The placebo PBMT device was identical to the active devices and displayed the same settings and emitted the same sound regardless of the comparator.

Group Type PLACEBO_COMPARATOR

PBMT

Intervention Type OTHER

Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.

Cryotherapy

Volunteers allocated in this group cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) were used in order to cover the entire quadriceps. Rubber belts were used to apply compression and to affix the packs tightly to the volunteers' quadriceps.

Group Type ACTIVE_COMPARATOR

Cryotherapy

Intervention Type OTHER

Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.

Interventions

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PBMT

Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.

Intervention Type OTHER

Cryotherapy

Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.

Intervention Type OTHER

Other Intervention Names

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photobiomodulation therapy

Eligibility Criteria

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Inclusion Criteria

* Subjects were included in the study if they performed less than 2 exercise session per week

Exclusion Criteria

* Subjects were excluded if occurred any musculoskeletal injury to hips or knees within the previous two months,
* if they were currently using pharmacological agents or nutritional supplements regularly,
* if a musculoskeletal injury during the study occurred or if they reported use of either alcohol or tobacco.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Multi Radiance Medical

INDUSTRY

Sponsor Role collaborator

University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Adriane Aver Vanin

PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernesto Cesar P Leal-Junior, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.

Reference Type RESULT
PMID: 24942380 (View on PubMed)

Grandinetti Vdos S, Miranda EF, Johnson DS, de Paiva PR, Tomazoni SS, Vanin AA, Albuquerque-Pontes GM, Frigo L, Marcos RL, de Carvalho Pde T, Leal-Junior EC. The thermal impact of phototherapy with concurrent super-pulsed lasers and red and infrared LEDs on human skin. Lasers Med Sci. 2015 Jul;30(5):1575-81. doi: 10.1007/s10103-015-1755-0. Epub 2015 May 19.

Reference Type RESULT
PMID: 25987340 (View on PubMed)

Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.

Reference Type RESULT
PMID: 20602109 (View on PubMed)

Graham CA, Stevenson J. Frozen chips: an unusual cause of severe frostbite injury. Br J Sports Med. 2000 Oct;34(5):382-3. doi: 10.1136/bjsm.34.5.382.

Reference Type RESULT
PMID: 11049150 (View on PubMed)

Moeller JL, Monroe J, McKeag DB. Cryotherapy-induced common peroneal nerve palsy. Clin J Sport Med. 1997 Jul;7(3):212-6. doi: 10.1097/00042752-199707000-00011.

Reference Type RESULT
PMID: 9262890 (View on PubMed)

Bassett FH 3rd, Kirkpatrick JS, Engelhardt DL, Malone TR. Cryotherapy-induced nerve injury. Am J Sports Med. 1992 Sep-Oct;20(5):516-8. doi: 10.1177/036354659202000505.

Reference Type RESULT
PMID: 1443317 (View on PubMed)

Other Identifiers

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CEP 470.174

Identifier Type: -

Identifier Source: org_study_id

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