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Dry Needling Dosage in the Treatment of Myofascial Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry needling
Control
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 53 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS

Exclusion Criteria:

  • Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Dry needling: 4 local twitch responses

    Dry needling: 6 local twitch responses

    Dry needling: Until no more local twitch responses elicited

    Control

    Arm Description

    Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited.

    Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited.

    Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited.

    The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion.

    Outcomes

    Primary Outcome Measures

    Pain
    Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
    Postneedling soreness
    Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).

    Secondary Outcome Measures

    Pressure pain threshold
    Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
    Cervical range of motion
    The subjects sat in a chair and a CROM goniometer was placed over the head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated.
    Neck disability
    Neck Disability Index questionnarie was completed.
    Pain in cervical range of motion
    Pain in a numerical pain rating scale during all cervical movements was recorded.
    Psychological factors
    State Trait Anxiety Inventory (STAI-T)
    Psychological factors
    Beck Depression Inventory (BDI-II)
    Psychological factors
    Tampa Scale for Kinesiophobia
    Psychological factors
    Pain Catastrophizing Scale

    Full Information

    First Posted
    July 4, 2014
    Last Updated
    December 5, 2017
    Sponsor
    Universidad Rey Juan Carlos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02190890
    Brief Title
    Dry Needling Dosage in the Treatment of Myofascial Neck Pain
    Official Title
    Effects of Different Deep Dry Needling Dosages on Pain and Postneedling Soreness in the Treatment of Patients With Cervical Myofascial Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Rey Juan Carlos

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dry needling: 4 local twitch responses
    Arm Type
    Experimental
    Arm Description
    Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited.
    Arm Title
    Dry needling: 6 local twitch responses
    Arm Type
    Experimental
    Arm Description
    Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited.
    Arm Title
    Dry needling: Until no more local twitch responses elicited
    Arm Type
    Experimental
    Arm Description
    Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dry needling
    Intervention Type
    Procedure
    Intervention Name(s)
    Control
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
    Time Frame
    1 week
    Title
    Postneedling soreness
    Description
    Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Pressure pain threshold
    Description
    Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
    Time Frame
    1 week
    Title
    Cervical range of motion
    Description
    The subjects sat in a chair and a CROM goniometer was placed over the head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated.
    Time Frame
    1 week
    Title
    Neck disability
    Description
    Neck Disability Index questionnarie was completed.
    Time Frame
    1 week
    Title
    Pain in cervical range of motion
    Description
    Pain in a numerical pain rating scale during all cervical movements was recorded.
    Time Frame
    1 week
    Title
    Psychological factors
    Description
    State Trait Anxiety Inventory (STAI-T)
    Time Frame
    Pre-intervention
    Title
    Psychological factors
    Description
    Beck Depression Inventory (BDI-II)
    Time Frame
    Pre-intervention
    Title
    Psychological factors
    Description
    Tampa Scale for Kinesiophobia
    Time Frame
    Pre-intervention
    Title
    Psychological factors
    Description
    Pain Catastrophizing Scale
    Time Frame
    Pre-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    53 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS Exclusion Criteria: Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29857165
    Citation
    Martin-Pintado-Zugasti A, Fernandez-Carnero J, Leon-Hernandez JV, Calvo-Lobo C, Beltran-Alacreu H, Alguacil-Diego I, Gallego-Izquierdo T, Pecos-Martin D. Postneedling Soreness and Tenderness After Different Dosages of Dry Needling of an Active Myofascial Trigger Point in Patients With Neck Pain: A Randomized Controlled Trial. PM R. 2018 Dec;10(12):1311-1320. doi: 10.1016/j.pmrj.2018.05.015. Epub 2018 May 29.
    Results Reference
    derived

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    Dry Needling Dosage in the Treatment of Myofascial Neck Pain

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