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Dry Needling in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry needling
Sham Dry needling
Manual therapy
Sponsored by
European University of Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Neck pain for at least three months (or more)
  • An active trigger point in either the upper trapezius or the levator scapulae

Exclusion criteria

  • Treatment for neck pain within the previous six months
  • Neck Whiplash
  • Fibromyalgia
  • Infection in the area under treatment
  • Pharmacological treatment with anti-coagulants
  • Fear to needles
  • Degenerative conditions
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Other

    No Intervention

    Arm Label

    Manual therapy + Dry needling

    Manual therapy + Sham Dry needling

    Untreated control

    Arm Description

    Manual therapy + Dry needling: 2 sessions, after a 7 days interval

    Manual therapy + Sham Dry needling: after a 7 days interval

    Natural history of the condition

    Outcomes

    Primary Outcome Measures

    Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
    The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS

    Secondary Outcome Measures

    Change in the Pressure Pain Threshold Measured by Algometer
    Measured by algometer, with the standard measurement procedure
    Change in the Cervical Range of Motion Measured by Goniometer
    Measured by goniometer, with the standard measurement procedure
    Change in the Neck Disability Index Questionnaire

    Full Information

    First Posted
    March 27, 2015
    Last Updated
    August 8, 2015
    Sponsor
    European University of Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02435966
    Brief Title
    Dry Needling in Patients With Chronic Neck Pain
    Official Title
    Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    European University of Madrid

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.
    Detailed Description
    A prospective single-blind randomized controlled trial, designed to assess the efficacy of dry needling in the treatment of chronic neck pain. The treatment regimes simulate the standard physiotherapy administered in real clinical settings. Patients in the intervention group receive a combination of manual therapy and dry needling (40mmx0,32 guided needles). There are two control groups. In the first one, patients receive a combination of manual therapy and sham dry needling. In the second control group, patients receive no treatment in order to assess the natural history of the disease. Patients receive two treatment sessions with an interval of 7 days and are followed up after 30 days. The primary outcome is subjective pain assessed with a Visual Analogue Scale (VAS). Secondary outcomes are pressure pain threshold (assessed with a manual algometer), neck range of motion (assessed with a goniometer) and the Neck Disability Index (a standardized questionnaire). Measurements are taken pre and post-test after the first and the second treatment sessions, plus once more at the follow-up, except for the Neck Disability Index (only at the beginning and after the second treatment). In the non-treated group, patients were measured at the same time intervals. The sample size was calculated to detect a VAS difference of 2 points, the minimally clinically important difference established in the literature. Then it was doubled in order to avoid possible dropouts. The trial takes place in a private practice in Madrid (Physios, c/Valverde 26). Patients are randomized by a computer program. Patients are explored for active trigger points in the upper trapezius and the levator scapulae. They should meet the criteria of identification established by Travell & Simons in their Trigger point manual. The investigators also seek for trigger points following Travell & Simons' pain maps for these two muscles, where they identify five trigger point areas. The investigators select the most active, taking pressure pain threshold measurements of all the active trigger point, normalizing the values according to normal thresholds for each of the five areas in the two muscles. The normal thresholds were assessed in a pilot study with healthy patients. The investigators administer either dry or sham dry needling to the most active (the one with the lowest pain threshold) throughout the trial. Dry needling is applied following Hong's technique with 40mmx0,32 guided needles, by a physiotherapist with 4 years of experience in the technique.

    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
    Participant
    Allocation
    Randomized
    Enrollment
    131 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual therapy + Dry needling
    Arm Type
    Experimental
    Arm Description
    Manual therapy + Dry needling: 2 sessions, after a 7 days interval
    Arm Title
    Manual therapy + Sham Dry needling
    Arm Type
    Other
    Arm Description
    Manual therapy + Sham Dry needling: after a 7 days interval
    Arm Title
    Untreated control
    Arm Type
    No Intervention
    Arm Description
    Natural history of the condition
    Intervention Type
    Device
    Intervention Name(s)
    Dry needling
    Intervention Description
    Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
    Intervention Type
    Device
    Intervention Name(s)
    Sham Dry needling
    Intervention Description
    Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
    Intervention Type
    Other
    Intervention Name(s)
    Manual therapy
    Intervention Description
    Standard manual therapy in the upper trapezius or the levator scapulae
    Primary Outcome Measure Information:
    Title
    Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
    Description
    The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
    Time Frame
    Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
    Secondary Outcome Measure Information:
    Title
    Change in the Pressure Pain Threshold Measured by Algometer
    Description
    Measured by algometer, with the standard measurement procedure
    Time Frame
    Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
    Title
    Change in the Cervical Range of Motion Measured by Goniometer
    Description
    Measured by goniometer, with the standard measurement procedure
    Time Frame
    Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
    Title
    Change in the Neck Disability Index Questionnaire
    Time Frame
    Pre-intervention (Day 1); after 2nd intervention (7 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Neck pain for at least three months (or more) An active trigger point in either the upper trapezius or the levator scapulae Exclusion criteria Treatment for neck pain within the previous six months Neck Whiplash Fibromyalgia Infection in the area under treatment Pharmacological treatment with anti-coagulants Fear to needles Degenerative conditions Pregnancy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32202124
    Citation
    Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.
    Results Reference
    derived

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    Dry Needling in Patients With Chronic Neck Pain

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