Sedentary LifestyleNCT03448120
Acupuncture and Dry Needling in Peripheral Acute Fatigue Reduction
A study testing Acupuncture and Dry needling in people with Sedentary Lifestyle and Males, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Males
- What is being tested?
- Acupuncture and Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Feb 2018to 21 Dec 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male individuals, aged between 18 and 40 years and who are not practicing regular physical activity (sedentary lifestyle).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
Recife, Pernambuco, 50670-901
About this study
Official title: 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.
- Conditions
- Sedentary Lifestyle, Males
- Being tested
- Acupuncture, Dry needling
- Keywords
- Muscle fatigue, Thermography, Acupuncture, Dry needling
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Six needled will be inserted in six already defined acupoints along the non-dominant upper limb for a period of 30 minutes.
Dry needlingProcedure or surgery
Six needles will be inserted in six predefined points along the volunteers non-dominant biceps brachialis for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The volunteers who will remain in prolonged rest (10 minutes for homeostasis plus 30 minutes of no intervention). |
| Acupuncture Group | Experimental | The volunteers will receive six needles in six acupoints in the non-dominant upper limb for 30 minutes. Receives: Procedure: Acupuncture |
| Dry needling Group | Experimental | The volunteers will receive application of six needles arranged in the non-dominant biceps brachialis for 30 minutes. Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of muscle fatigue
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.
Measured: 60 minutes
Muscle temperature
Infrared thermographic Imaging analysis of acute peripheral muscle fatigue.
Measured: 60 minutes
Muscle fatigue
Electromyographic activity (in microvolts) of the biceps brachii muscle to assess muscle fatigue through the median frequency (MF).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start26 Feb 2018
- Primary completion16 Nov 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448120
- Sponsor's protocol ID
- Muscle Fatigue, Acupunture and
- Other IDs
- UFPE
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Antonino GB, Paula de Lima Ferreira A, Nepomuceno Montenegro EJ, Galvao de Moura Filho A, Freire da Silva AF, de Araujo MDGR. Acupuncture and Dry Needling in the Reduction of Peripheral Acute Fatigue Induced in the Biceps Braquii: Protocol for a Single-blinded Randomized Controlled Clinical Trial. J Acupunct Meridian Stud. 2020 Oct;13(5):163-166. doi: 10.1016/j.jams.2020.08.001. Epub 2020 Sep 1.
PubMed 32889135
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Dry Needling in Peripheral Acute Fatigue Reduction Induced in Biceps Brachialis: Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03448120
- Acronym / sponsor ID
- Muscle Fatigue, Acupunture and
- Conditions
- Sedentary Lifestyle, Males
- Keywords
- Muscle fatigue, Thermography, Acupuncture, Dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 27 Feb 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The volunteers who will remain in prolonged rest (10 minutes for homeostasis plus 30 minutes of no intervention). |
| Acupuncture Group | Experimental | Procedure: AcupunctureThe volunteers will receive six needles in six acupoints in the non-dominant upper limb for 30 minutes. |
| Dry needling Group | Experimental | Procedure: Dry needlingThe volunteers will receive application of six needles arranged in the non-dominant biceps brachialis for 30 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male individuals, aged between 18 and 40 years and who are not practicing regular physical activity (sedentary lifestyle).
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| AcupunctureSix needled will be inserted in six already defined acupoints along the non-dominant upper limb for a period of 30 minutes. | Procedure or surgery | Acupuncture Group |
| Dry needlingSix needles will be inserted in six predefined points along the volunteers non-dominant biceps brachialis for 30 minutes. | Procedure or surgery | Dry needling Group |
Primary outcome
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.
Muscle temperature
Time frame: 60 minutes
Infrared thermographic Imaging analysis of acute peripheral muscle fatigue.
Muscle fatigue
Time frame: 60 minutes
Electromyographic activity (in microvolts) of the biceps brachii muscle to assess muscle fatigue through the median frequency (MF).
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 2 Mar 2022.
- Derived from this study: PubMed 32889135Antonino GB, Paula de Lima Ferreira A, Nepomuceno Montenegro EJ, Galvao de Moura Filho A, Freire da Silva AF, de Araujo MDGR. Acupuncture and Dry Needling in the Reduction of Peripheral Acute Fatigue Induced in the Biceps Braquii: Protocol for a Single-blinded Randomized Controlled Clinical Trial. J Acupunct Meridian Stud. 2020 Oct;13(5):163-166. doi: 10.1016/j.jams.2020.08.001. Epub 2020 Sep 1.
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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 Acupuncture and Dry needling in people with Sedentary Lifestyle and Males, run by Universidade Federal de Pernambuco 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 8 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 2 Mar 2022. 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?
Perception of muscle fatigue (time frame: 60 minutes). The study lists 3 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 NCT03448120, which also lists 1 linked publication.
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 2 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.