We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dry Needling in Patients With Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435966
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Gracia Gallego Sendarrubias, European University of Madrid

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.

Condition or disease Intervention/treatment Phase
Neck Pain Device: Dry needling Device: Sham Dry needling Other: Manual therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
Study Start Date : May 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: Manual therapy + Dry needling
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Device: Dry needling
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)

Other: Manual therapy
Standard manual therapy in the upper trapezius or the levator scapulae

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

Other: Manual therapy
Standard manual therapy in the upper trapezius or the levator scapulae

No Intervention: Untreated control
Natural history of the condition



Primary Outcome Measures :
  1. Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
    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 :
  1. Change in the Pressure Pain Threshold Measured by Algometer [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
    Measured by algometer, with the standard measurement procedure

  2. Change in the Cervical Range of Motion Measured by Goniometer [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
    Measured by goniometer, with the standard measurement procedure

  3. Change in the Neck Disability Index Questionnaire [ Time Frame: Pre-intervention (Day 1); after 2nd intervention (7 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gracia Gallego Sendarrubias, Fisioterapeuta, European University of Madrid
ClinicalTrials.gov Identifier: NCT02435966    
Other Study ID Numbers: University European of Madrid
First Posted: May 6, 2015    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Neck Pain
Pain
Neurologic Manifestations