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Trial registered on ANZCTR
Registration number
ACTRN12619000874112
Ethics application status
Approved
Date submitted
22/05/2019
Date registered
19/06/2019
Date last updated
17/09/2020
Date data sharing statement initially provided
19/06/2019
Date results information initially provided
11/02/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Post-needling soreness depending on the time of dry
needling (before, during and after a manual therapy
protocol) of an active myofascial trigger point in the
upper trapezius muscle in patients with mechanical neck pain.
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Scientific title
Post-needling soreness depending on the time of dry
needling (before, during and after a manual therapy
protocol) of an active myofascial trigger point in the
upper trapezius muscle in patients with mechanical neck pain. A randomized controlled clinical trial.
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Secondary ID [1]
298302
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mechanical neck pain.
312933
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Condition category
Condition code
Musculoskeletal
311425
311425
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomly divided into 3 groups and all of them will receive a manual therapy and dry needling treatment. In each group, the dry needling will be performed at different
times: 10 mins before manual therapy, 5 mins into the manual therapy and 10 mins after manual therapy.
Description of the manual therapy:
Pressure release over the upper trapezius will be applied. Briefly, pressure will be progressively increased over the upper trapezius until a definite increase in tissue resistance (barrier) will be perceived by the therapist. This pressure will be maintained until the clinician senses a relief of the taut band. This process will be repeated 3 times at each session.
Patients also will receive a stretching intervention of the taut-band muscle fibers. The therapist applied moderate, slow pressure over the upper trapezius, sliding the fingers in opposite directions (3 longitudinal sweeps, with an approximate duration of 20 seconds per sweep). Trigger point manual therapy will be applied slowly, without inducing pain.
Finally, passive stretching of the upper trapezius muscle will be also performed for 45 seconds.
Description of the dry needling treatment:
The dry needling treatment will be performed with disposable stainless-steel needles (0.32 × 40 mm) inserted into the skin over the upper trapezius area, using the fast-in and fast-out technique described by Hong. Once the upper trapezius is located with pincer palpation in the upper trapezius, the overlying skin will be cleaned with alcohol. The needle will be inserted into the upper trapezius until a local twitch response is obtained. A total of 10 repetitions will be made. The duration of the dry needling treatment will be 20 seconds.
The manual therapy and the dry needling treatment will be administered by a physiotherapist.
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Intervention code [1]
314537
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Treatment: Other
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Comparator / control treatment
All three groups are compared to one another.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in Post-needling soreness.
Instrument to be used for the assessment: algometer.
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Assessment method [1]
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Timepoint [1]
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Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
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Secondary outcome [1]
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Change in pressure pain threshold.
Instrument to be used for de assessment: algometer
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Assessment method [1]
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Timepoint [1]
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Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
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Secondary outcome [2]
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Change in cervical range of motion.
Instrument to be used for de assessment: cervical goniometer.
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Assessment method [2]
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Timepoint [2]
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Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
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Secondary outcome [3]
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Change in disability.
Instrument to be used for de assessment: neck disability index questionnaire.
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Assessment method [3]
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Timepoint [3]
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Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
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Eligibility
Key inclusion criteria
Volunteer patients (men and women) with mechanical neck pain (of at
least 3 months evolution and intensity of 3 centimeters in the visual analogue scale) and active myofascial trigger point in the upper trapezius muscle will be recruited.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Fear of needles, coagulation disorders, previous cervical surgery, current or previous whiplash diagnosis, cervical radiculopathy or myelopathy, diagnosis of fibromyalgia, Thyroid disorders, dizziness and vertigo, some contraindication of dry needling (the use of anticoagulants,
psychiatric disorders, etc.).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Epidat 4.0)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
21/06/2019
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Actual
21/06/2019
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Date of last participant enrolment
Anticipated
5/11/2019
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Actual
5/11/2019
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Date of last data collection
Anticipated
25/02/2020
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Actual
25/02/2020
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Sample size
Target
108
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Accrual to date
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Final
108
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
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Madrid
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Universidad de Alcalá
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Address [1]
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Av. de León, 3A, 28805 Alcalá de Henares, Madrid
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Country [1]
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Spain
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Primary sponsor type
Individual
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Name
Sara Sánchez Hernández
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Address
Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
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Country
Spain
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Secondary sponsor category [1]
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University
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Name [1]
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Juan Manuel Rodriguez Gomez
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Address [1]
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Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
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Country [1]
302795
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Spain
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Comité de Ética de la Investigación y de Experimentación Animal de la Univerdad de Alcalá
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Ethics committee address [1]
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San Diego Square, 28801, Alcalá de Henares, Madrid.
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Ethics committee country [1]
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Spain
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Date submitted for ethics approval [1]
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Approval date [1]
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22/01/2019
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Ethics approval number [1]
303422
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Summary
Brief summary
Hypothesis: the moment of execution of the dry needling technique, (before, in the middle and after a manual therapy protocol) in an active myofascial trigger point of the upper trapezius in patients with mechanical neck pain, decreases post-needling soreness.
Objective: find out if the moment of execution of the dry needling technique within a
manual therapy protocol could decrease the intensity and duration of post-needling soreness in patients with an active myofascial trigger point in the upper trapezius and mechanical pain
of the neck.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Sara Sánchez Hernández
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Address
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Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
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Country
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Spain
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Phone
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+34918854574
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Fax
93626
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Email
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[email protected]
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Contact person for public queries
Name
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Miss Sara Sánchez Hernández
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Address
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Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid.
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Country
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Spain
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Phone
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+34918854574
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Fax
93627
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Email
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[email protected]
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Contact person for scientific queries
Name
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Miss Sara Sánchez Hernández
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Address
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Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid.
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Country
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Spain
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Phone
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+34918854574
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Fax
93628
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
377642-(Uploaded-01-04-2020-05-14-00)-Basic results summary.docx
Plain language summary
No
Research question: could execution time of the dry...
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