Delayed Onset Muscle SorenessNCT03619928
Comparison of Dry Needle and Massotherapy on Tolerance Effort and Soreness
A study testing Dry needling and Massotherapy in people with Delayed Onset Muscle Soreness, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Dry needling and Massotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jul 2018to 1 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not practicing physical activity BMI greater than 18 and less than 30 members of the UFPE community
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Romero Souza Leão de Albergaria Crasto
Recife, Pernambuco, 50670-901
Romero SL Crasto, 81992266788, romeroslac@gmail.com
About this study
Official title: 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.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Dry needling, Massotherapy
- Keywords
- Dry needling, Massotherapy, Delayed onset muscle soreness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
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.
MassotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | 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 Receives: Device: Dry needling |
| Massotherapy | Active comparator | 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. Receives: Device: Massotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
Algometry
Measured: 48 hours
Delayed onset muscle soreness
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.
Measured: 48 hours
Secondary outcomes (3)
Muscle thickness
Ultrassonography
Measured: 48 hours
Temperature
Thermography
Measured: 48 hours
Time limit
Isometric performance test
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start27 Jul 2018
- Primary completion27 Aug 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle SorenessStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROMERO SOUZA LEÃO DE ALBERGARIA CRASTO, Universidade Federal de Pernambuco
- Investigators
- Romero SL Crasto, Esp., Principal investigator, Master student, program in physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619928
- Sponsor's protocol ID
- DN, massotherapy and DOMS
- Status last verified
- Jul 2018
- First submitted
- 27 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry Needle and Massotherapy on Tolerance to the Effort and Soreness of Individuals With Late Muscular Pain Induced by Exercise
- ClinicalTrials.gov ID
- NCT03619928
- Acronym / sponsor ID
- DN, massotherapy and DOMS
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- Dry needling, Massotherapy, Delayed onset muscle soreness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 27 Aug 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 8 Aug 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: 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Device: Dry needlingProcedure 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 |
| Massotherapy | Active comparator | Device: MassotherapyAmong 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- not practicing physical activity BMI greater than 18 and less than 30 members of the UFPE community
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Dry needling20 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. | Device | Dry needling |
| MassotherapyA 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. | Device | Massotherapy |
Primary outcome
Pressure pain threshold
Time frame: 48 hours
Algometry
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.
3 secondary outcomes
Muscle thickness
Time frame: 48 hours
Temperature
Time frame: 48 hours
Time limit
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Romero SL Crasto, Esp. principal investigator
Master student, program in physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Massotherapy in people with Delayed Onset Muscle Soreness, 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 1 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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romero SL Crasto, Esp. (81992266788, romeroslac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2018.