Comparison of Dry Needle and Massotherapy on Tolerance Effort and Soreness

August 2, 2018 updated by: ROMERO SOUZA LEÃO DE ALBERGARIA CRASTO, Universidade Federal de Pernambuco

Comparison of Dry Needle and Massotherapy on Tolerance to the Effort and Soreness of Individuals With Late Muscular Pain Induced by Exercise

Introduction: Delayed onset muscle soreness (DOMS) is a common myogenic condition considered to be a muscle tension injury frequently observed in recreational or experienced athletes, induced in the majority of cases by eccentric and inactive exercises, the most common of which are: tension, pain and impairment muscular and have a course of typical duration of 24 hours and peak between 48 and 72 hours. Among the treatments proposed with the aim of reducing the symptoms of DOMS is massage therapy. However, dry needling is a relatively new technique that has been used in myotendinous lesions and its effects on late muscle pain have not yet been studied. Objective: To compare the impact of dry needling and massage therapy on exercise tolerance, and analgesia of sedentary individuals with late muscle pain induced by eccentric exercise. The present study is characterized as a randomized and blinded comparative study in which male sedentary individuals will be invited in which the late muscle pain will be induced through eccentric contractions and will receive different treatments: dry needling or massage therapy. The upper limb functionality, pain perception, superficial hyperemia and brachial biceps thickness will be compared through the exams: visual analogue pain scale (VAS), digital algometry, thermography, ultrasonography and isometric test.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Recruiting
        • Romero Souza Leão de Albergaria Crasto
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

not practicing physical activity BMI greater than 18 and less than 30 members of the UFPE community

Exclusion Criteria:

making use of analgesic or anti-inflammatory medications acupuncture or dry needling or massage therapy in the last 6 months report of muscle pain orthopedic neurological problems hypertension and diabetes cardiovascular or respiratory diseases

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry needling
Procedure in which a thin needle is used to penetrate the skin, subcutaneous tissues and muscle with the intention of mechanically stimulating the tissue without the use of an anesthetic. The physiological mechanism supporting the effects of dry needling remains to be clarified. It has been suggested that the needle works according to the pain gate control theory, indicating that one type of sensory input could be inhibited in the Central nervous system by another input
Device: Dry needling
20 minutes through a sterile, disposable Dong Bang® needle size of 0.25X30 mm. At the moment of insertion of the needle, the therapist will perform a muscular shortening around the application site, in a pincer movement performed by the index and thumb fingers, in order to isolate the muscle fibers of the biceps brachii. Five needles will be applied to the short head brachii biceps in five points: origin, insertion, center of the muscular womb (60% of the distance from the medial acromion to the cubital fossa in the elbow line) and two points equidistant from the center 2 cm.
Active Comparator: Massotherapy
Among the therapeutic approaches for DOMS is massage therapy. Several authors have examined the effects of DOMS massage and indirect markers of muscle damage, such as impaired muscle function, edema and muscle changes in blood proteins.
Device: Massotherapy
A 20-minute massage will be applied to the non-dominant upper limb exercised by a therapist for the massage condition. The massage will consist of: 1) surface slip; 2) deep slip; 3) kneading; 4) friction with the thumbs; 5) friction with four fingers; 6) percussions with open and alternating hands; 7) percussions with open and simultaneous hands; 8) tapping; and 9) surface slip.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: 48 hours
Algometry
48 hours
Delayed onset muscle soreness
Time Frame: 48 hours
Visual analogue scale which measures the pain and whose minimum value is zero and the maximum value is 100 millimeters. The higher value is the worse the pain.
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle thickness
Time Frame: 48 hours
Ultrassonography
48 hours
Temperature
Time Frame: 48 hours
Thermography
48 hours
Time limit
Time Frame: 48 hours
Isometric performance test
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Romero SL Crasto, Esp., Master student, program in physical therapy

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DN, massotherapy and DOMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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