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Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain

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ClinicalTrials.gov Identifier: NCT02219386
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Ester Cerezo-Téllez, University of Alcala

Tracking Information
First Submitted Date  ICMJE August 8, 2014
First Posted Date  ICMJE August 18, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) [ Time Frame: pretreatment, postreatment and follow-up(15 days) ]
pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks) [ Time Frame: Pretreatment, post treatment and follow-up. ]
pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 15, 2014)
  • Strenght scored by Digital dynamometer (Participants were followed for the duration of the intervention, an average of 6 weeks) [ Time Frame: Pretreatment, post treatment and follow-up. ]
    pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
  • Cervical Range of Motion assesed with CROM goniometer (Participants were followed for the duration of the intervention, an average of 6 weeks) [ Time Frame: Pretreatment, post treatment and follow-up. ]
    pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. Participants were followed for the duration of the intervention, an average of 6 weeks)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain
Official Title  ICMJE Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain. Randomised, Single Blinded Clinical Trial
Brief Summary Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients
Detailed Description

EVALUATION:

A blind assesor does a complete evaluation of the patients to determine if they take part of the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in Newtons) are performed. In this evaluation inclusion criteria is checked too.

INTERVENTION:

-TREATMENT GROUP(Deep dry needling group (DDN)):

An experienced physical therapist performed this treatment. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP.

After that, the stretch is performed

- Passive stretch of the trapezius muscle (both groups)

Another experienced physical therapist, after taking part of training-sesions to do the same stretch as in DDN group, performed the stretch.Participants in this group received the same stretch as patients in treatment group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myofascial Trigger Point Pain
Intervention  ICMJE
  • Other: Group 1. Deep dry needling
    Deep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle.
  • Other: group 2. Passive analitical stretch (performed in both groups)
    Other Name: only the same stretch as performed in deep dry needling group.
Study Arms  ICMJE
  • Active Comparator: Deep dry needling
    The group of DDN receive this treatment and stretch
    Intervention: Other: Group 1. Deep dry needling
  • muscle stretch
    The stretch applied was as described by Simons et al. (Simons et al., 1999). During the stretch the physiotherapist took up the slack, avoiding pain elicitation, maintaining the tension for four seconds and releasing the tension for eight seconds; this cycle was repeated three times
    Interventions:
    • Other: Group 1. Deep dry needling
    • Other: group 2. Passive analitical stretch (performed in both groups)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2014)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • over 18
  • present myofascial trigger points in trapezius muscle

Exclusion Criteria:

  • to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or antidepressant medication at the start of the study or one week before it (Simons, 2004)
  • to suffer from fibromyalgia syndrome, or to have any contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219386
Other Study ID Numbers  ICMJE 44/11Comision of investigation
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ester Cerezo-Téllez, University of Alcala
Study Sponsor  ICMJE University of Alcala
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ester Cerezo-Téllez, PT Alcalá University
PRS Account University of Alcala
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP