Acupuncture and Dry Needling in Peripheral Acute Fatigue Reduction

February 10, 2022 updated by: Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco

Acupuncture and Dry Needling in Peripheral Acute Fatigue Reduction Induced in Biceps Brachialis: Cross-Sectional Study

Introduction: Neuromuscular fatigue is defined when the muscle becomes incapable of generating muscle power or strength after exercise or long repetitive activities. As well as, the inability to maintain optimum performance and generate maximum voluntary contractions during a physical exercise. When performing physical activity, the body's metabolic response increases proportionally to exercise to satisfy the demands of the human physiological. Part of the energy accumulated during exercise is lost to the environment in the form of heat and another part is maintained internally through the physiological control for thermoregulation. In addition, the muscle generates an electric signal important to determine its status regarding power and fatigue.

Objective: To investigate the reduction of acute peripheral fatigue induced by isometric contractions from acupuncture and dry needling techniques, compared to absolute rest.

Methods: This is a cross-sectional study and experimental study, with descriptive, analytical and quantitative approach. It follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The volunteers will be gathered according to the eligibility criteria, and randomly divided in 3 groups: the control group (G1), the volunteers who will remain in prolonged rest; the acupuncture group (G2), in which volunteers will receive six needles in six acupoints in the non-dominant upper limb and the dry needling group (G3), in which the volunteers will receive application of six needles arranged in the non-dominant biceps brachialis.

Study Overview

Status

Status

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

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 (Actual)

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.
45

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 Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male individuals, aged between 18 and 40 years and who are not practicing regular physical activity (sedentary lifestyle).

Exclusion Criteria:

  • Are using food supplementation;
  • Have joint or bone lesions on the limb to be studied;
  • Have problems of metabolic order;
  • Use of hormone therapy;
  • Have had caffeine in the two hours before the study;
  • Have ulceration or wounds in the electrode application region for electromyography;
  • Show absence of myofascial trigger points in areas of dry needling technique;
  • Body Mass Index below normal values or higher than overweight.

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: Factorial Assignment
  • Masking: Single

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.
No Intervention: Control Group
The volunteers who will remain in prolonged rest (10 minutes for homeostasis plus 30 minutes of no intervention).
Experimental: Acupuncture Group
The volunteers will receive six needles in six acupoints in the non-dominant upper limb for 30 minutes.
Procedure: Acupuncture
Six needled will be inserted in six already defined acupoints along the non-dominant upper limb for a period of 30 minutes.
Experimental: Dry needling Group
The volunteers will receive application of six needles arranged in the non-dominant biceps brachialis for 30 minutes.
Procedure: Dry needling
Six needles will be inserted in six predefined points along the volunteers non-dominant biceps brachialis for 30 minutes.

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
Perception of muscle fatigue
Time Frame: 60 minutes
Fatigue perception measured by Visual Analog Scale for fatigue assessment, graduated from 0,00 to 10,0 centimeters, being 0,00 no fatigue and 10,0 maximum fatigue.
60 minutes
Muscle temperature
Time Frame: 60 minutes
Infrared thermographic Imaging analysis of acute peripheral muscle fatigue.
60 minutes
Muscle fatigue
Time Frame: 60 minutes
Electromyographic activity (in microvolts) of the biceps brachii muscle to assess muscle fatigue through the median frequency (MF).
60 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contraction time
Time Frame: 60 minutes
The time of intermittent isometric contractions was delimited by the number of valid contractions during each exercise
60 minutes

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

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

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.
February 26, 2018

Primary Completion (Actual)

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.
November 16, 2018

Study Completion (Actual)

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.
December 21, 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).
February 21, 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.
February 21, 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.
February 27, 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.
March 2, 2022

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.
February 10, 2022

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.
February 1, 2022

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.
  • Muscle Fatigue, Acupunture and
  • UFPE (CAAE N. 79139717.6.0000.5208)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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