NCT03619928

Brief 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 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.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

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

July 27, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 8, 2018

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

July 27, 2018

Last Update Submit

August 2, 2018

Conditions

Keywords

Dry needlingMassotherapyDelayed onset muscle soreness

Outcome Measures

Primary Outcomes (2)

  • Pressure pain threshold

    Algometry

    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.

    48 hours

Secondary Outcomes (3)

  • Muscle thickness

    48 hours

  • Temperature

    48 hours

  • Time limit

    48 hours

Study Arms (2)

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

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.

Device: Massotherapy

Interventions

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.

Dry needling

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.

Massotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Romero Souza Leão de Albergaria Crasto

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Romero SL Crasto, Esp.

    Master student, program in physical therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romero SL Crasto, Esp.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal researcher

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 8, 2018

Study Start

July 27, 2018

Primary Completion

August 27, 2018

Study Completion

October 1, 2018

Last Updated

August 8, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations