NCT03241134

Brief Summary

An experimental study will be conducted to evaluate the effect of a single dry needling session, compared to a sham needling session, on surface EMG activity (signal amplitude and frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

August 2, 2017

Last Update Submit

December 12, 2023

Conditions

Keywords

Dry needlingSham needlingOffice workersMyofascial painSurface electromyography

Outcome Measures

Primary Outcomes (1)

  • Changes in resting surface EMG activity (amplitude, RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo

    Changes in resting EMG activity (amplitude, Root Mean Square) of the upper trapezius immediately after, 15 minutes and 30 minutes after dry needling, compared to EMG activity after a typing task, will be measured using surface electrodes placed bilaterally at the MTrP location of the upper trapezius. The change in resting surface EMG activity after dry needling will be compared with the change in surface EMG activity after sham needling. Resting surface EMG activity will be expressed as a percentage of a submaximal reference contractions of the upper trapezius (% reference contractions)

    Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes and 30 minutes after dry or sham needling

Secondary Outcomes (3)

  • Changes in surface EMG activity (amplitude, Root Mean Square) of the upper trapezius during a fatiguing typing task of 20 minutes as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo

    During the typing task, every five minutes EMG activity will be measured for 30 seconds

  • Changes in pain score after dry needling, compared to sham needling, as assessed by the numeric rating scale

    Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes after dry or sham needling, 30 minutes after dry or sham needling, daily during the seven days following the treatment

  • Changes in pain score after a typing task of 20 minutes as assessed by the numeric rating scale

    Immediately before and after a typing task of 20 minutes

Study Arms (2)

Dry needling

EXPERIMENTAL

A single dry needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down in multiple directions. In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct.

Other: Dry needling

Sham needling

SHAM COMPARATOR

A single sham needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated.

Other: Sham needling

Interventions

Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.

Dry needling

During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.

Sham needling

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Performing office work since at least one year
  • Performing computer based tasks for at least 20 hours a week
  • NRS \> or equal to 3/10
  • Clinical diagnosis of trapezius myalgia
  • Trapezius myalgia is work-related and thus aggravates during working day/ week
  • Presence of a trigger point in the upper trapezius muscle

You may not qualify if:

  • Being in treatment during the study
  • Traumatic injuries/surgery to neck and upper limb region
  • Signs of cervical nerve root impingement
  • Whiplash injury
  • Cardiovascular, neurological, life threatening, systemic and metabolic diseases
  • Diagnosis of fibromyalgia/chronic fatigue syndrome
  • Shoulder pathology
  • Coagulation disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

  • De Meulemeester K, Calders P, Cagnie B. Exploring the Underlying Mechanisms of Action of Dry Needling: What Is the Immediate Effect on Muscle Electrophysiology? An Experimental Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):18-25. doi: 10.1097/PHM.0000000000001732.

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Barbara Cagnie, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 7, 2017

Study Start

August 28, 2017

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations