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CompletedNCT04148469Updated Nov 1, 2019

Dry Needling Effectiveness and Post-punction Pain

An interventional study of Dry needling and Transcutaneous Nerve Stimulation. in Neck Pain, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 11 months after the study started (first participant enrolled Nov 2012, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.

Read the detailed description

All patients suffered from mechanical neck pain and were randomized into three groups of treatment. A doible blinded control was carryed out. The main outcome messures were Visual Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.

02

Conditions studied

  • Neck Pain

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Keywords

  • Miofascial pain syndrom.
  • Trigger point.
  • Dry needling.
  • Transcotaneous Nerve Stimuilation.
  • Hipoalgesia
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's enrollment of 68 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Mechanical Neck pain of at least 6 months.
  • VAS 2 or greather.
  • Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.

Exclusion criteria

Exclusion Criteria:

  • Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
  • Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
  • Neck pain with radiculopathy.
  • Whiplash.
  • Vertebrobasilar syndrome.
  • Dizzyness.
  • Pregnancy.
  • Having received dry needling treatment before.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    dry needling and TENS

    A dry needling treatment was performed on trapezius trigger point number 2, and just after thar, a TENS curretn was applied. Patients will be reassed on fourth day after treatment.

    Procedure: Transcutaneous Nerve Stimulation.

  • Placebo comparator
    Placebo

    A placebo dry needling was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.

    Procedure: Placebo needling

  • Experimental
    dry needling

    A dry needling treatment was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.

    Procedure: Dry needling

Interventions

  • ProcedureDry needling

    Dry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes.

  • ProcedureTranscutaneous Nerve Stimulation.

    Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes.

  • ProcedurePlacebo needling

    No active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    Visual Analogue Scale (VAS) is a subjective evaluation. There are previous studies that demonstrate its reliability and its sensitivity, wich give validity to VAS messures. The messure is made using a two sides 10 centimeters scale. The patient´s face shows an increasing slope that allows the patient to mark his pain level. That mark has his equivalent number on the scale, so 0 is no pain and 10 is maximum pain. A differece of 2 points on the scale means the minimum clinically significant change.

    Time frame: Patients will be reassed in four days.

Secondary outcomes

  1. Active Cervical Range of Movement

    To messure the cervical range of movement, a CROM will be used. The CROM is a special goniometer that allows therapists to messure cervical movements. It conists on trhee pairs of inclinometers that allow reserchers to messure range of flexion-extension, lateral flexion and rotation. The CROM has a porved reliability, providing a inter-meter reliability from 0,7 to 0,9 and an intra-meter reliability from 0,8 to 0,87. The patient will be seated on a cheir, and he´ll perform cervical movements actively, just untill he starts to feel his pain. Each movement will be messure three times, and the average will be taken.

    Time frame: Patient will be reassed in four days.

  2. Pressure Pain Threshold

    Pressure Pain Threshold (PPT) is the minimun pressure needed to araise pain. To messure PPT, an digital algometer will be used. An algometer consists on a 1 square centimeter rubber piece inserted on a pressure gauge. Previous studies have shown the reliability of this method (ICC=0,91) and also inter meter (ICC from 0,82 to 0,97) and intra meter (ICC=0,78). The minimun detectable change on the cervical area goes from 0,44 Kg/cm2 to 1,11 Kg/cm2. We will apply the algometer over trapezius trigger point number 2, and the patient will tell the therapist when he start to feel hgis pain. We´ll do the messure 3 times and the average will be taken.

    Time frame: Patients will be reassed in four days.

07

Study locations

1 site
  • Universidad Rey Juan Carlos
    Alcorcón, Madrid 28922, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04148469
Lead sponsor
Universidad Rey Juan Carlos
Responsible party
Josue Fernandez Carnero (PhD, Universidad Rey Juan Carlos) — Principal investigator
First posted
Nov 1, 2019
Start date
Nov 2012
Primary completion
Jun 12, 2013
Completion
Dec 10, 2013
Last update
Nov 1, 2019

Study contacts

Jose Vicente León Hernández, PT
principal investigator · Universitdad Rey Juan Carlos

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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