NCT04628403

Brief Summary

Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. In this regard, in order to accelerate the recovery of body systems and treat symptoms of DOMS, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. Objectives: To investigate the effect of different types of clinical interventions for the treatment of DOMS. Material and methods: For the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (CG), shock waves (G1) , massage (G2) and laser therapy (G3). The evaluation moments will be as follows: minutes before exercise (M1); immediately after exercise (M2); immediately after applying the recovery technique (M3); and 24 hours after exercise (M4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 26, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

October 26, 2020

Last Update Submit

November 12, 2020

Conditions

Keywords

LasertherapyShockwavesMassageSports MedicineAthletic Performance

Outcome Measures

Primary Outcomes (2)

  • PAIN

    pain systemic and located in quadriceps, assessed using a visual analog scale (0-10), with 0 indicating no pain and 10 the worst possible pain

    7 days

  • SATISFACTION

    Brunel's Mood Scale (BRUMS), with ratings from 0 to 4 where, 0 represents nothing; 1 represents a little, 2 indicates moderately; 3 reports a lot; and 4 corresponds to extremely

    7 days

Secondary Outcomes (1)

  • MUSCLE STRENGTH

    7 days

Study Arms (4)

control

NO INTERVENTION

shock waves

EXPERIMENTAL
Device: shock waves

massage

EXPERIMENTAL
Other: massage

lasertherapy

EXPERIMENTAL
Device: lasertherapy

Interventions

massageOTHER

clinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise

massage

lasertherapy

lasertherapy

shock waves

shock waves

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Professional athletes;
  • Age over 18 years;
  • Both sexes;
  • Not having recent injuries

You may not qualify if:

  • Participants who do not complete all the proposed collection moments
  • who do not agree to participate will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 78060-900, Brazil

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Roberto L Nahon, Dr

CONTACT

Jaqueline S Lopes, Dra

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the results assessor will not be aware of the subject allocation group
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 13, 2020

Study Start

November 20, 2020

Primary Completion

January 29, 2021

Study Completion

March 20, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations