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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 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.
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.
Secondary ID [1] 298302 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical neck pain. 312933 0
Condition category
Condition code
Musculoskeletal 311425 311425 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314537 0
Treatment: Other
Comparator / control treatment
All three groups are compared to one another.
Control group
Active

Outcomes
Primary outcome [1] 320144 0
Change in Post-needling soreness.
Instrument to be used for the assessment: algometer.
Timepoint [1] 320144 0
Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
Secondary outcome [1] 370694 0
Change in pressure pain threshold.
Instrument to be used for de assessment: algometer
Timepoint [1] 370694 0
Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
Secondary outcome [2] 370695 0
Change in cervical range of motion.
Instrument to be used for de assessment: cervical goniometer.
Timepoint [2] 370695 0
Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.
Secondary outcome [3] 370696 0
Change in disability.
Instrument to be used for de assessment: neck disability index questionnaire.
Timepoint [3] 370696 0
Before the intervention, immediate post-intervention, 48 hours (primary timepoint) and a week after intervention.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2019
Actual
21/06/2019
Date of last participant enrolment
Anticipated
5/11/2019
Actual
5/11/2019
Date of last data collection
Anticipated
25/02/2020
Actual
25/02/2020
Sample size
Target
108
Accrual to date
Final
108
Recruitment outside Australia
Country [1] 21518 0
Spain
State/province [1] 21518 0
Madrid

Funding & Sponsors
Funding source category [1] 302844 0
University
Name [1] 302844 0
Universidad de Alcalá
Country [1] 302844 0
Spain
Primary sponsor type
Individual
Name
Sara Sánchez Hernández
Address
Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 302795 0
University
Name [1] 302795 0
Juan Manuel Rodriguez Gomez
Address [1] 302795 0
Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country [1] 302795 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303422 0
Comité de Ética de la Investigación y de Experimentación Animal de la Univerdad de Alcalá
Ethics committee address [1] 303422 0
Ethics committee country [1] 303422 0
Spain
Date submitted for ethics approval [1] 303422 0
Approval date [1] 303422 0
22/01/2019
Ethics approval number [1] 303422 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93626 0
Miss Sara Sánchez Hernández
Address 93626 0
Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 93626 0
Spain
Phone 93626 0
+34918854574
Fax 93626 0
Email 93626 0
s.sanchez@edu.uah.es
Contact person for public queries
Name 93627 0
Sara Sánchez Hernández
Address 93627 0
Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid.
Country 93627 0
Spain
Phone 93627 0
+34918854574
Fax 93627 0
Email 93627 0
s.sanchez@edu.uah.es
Contact person for scientific queries
Name 93628 0
Sara Sánchez Hernández
Address 93628 0
Master's student at the University of Alcalá.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid.
Country 93628 0
Spain
Phone 93628 0
+34918854574
Fax 93628 0
Email 93628 0
s.sanchez@edu.uah.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.