NCT03787706

Brief Summary

There is evidence suggesting that patients with mechanical neck pain exhibit higher activity of the superficial neck flexor muscles during the execution of the cranio-cervical flexion test. In addition, some studies have reported the presence of active trigger points in the neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can affect motor control behaviour, it is possible that management of these trigger points with dry needling could be effective for improving muscle activity during low-load activities, such as the cranio-cervical flexion test. Therefore, the aim of this study will be to investigate the effects on electromyographical activity, pressure pain thresholds and cervical range of motion after the application of dry needling over active TrPs in the upper trapezius muscle in patients with mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

December 22, 2018

Last Update Submit

September 27, 2021

Conditions

Keywords

Neck PainTrigger pointsDry needlingCranio-cervical flexion test

Outcome Measures

Primary Outcomes (1)

  • Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention

    Bipolar surface EMG will be recorded with pairs of electrodes positioned 20mm apart and fixed firmly with an adhesive tape bilaterally over the sternocleidomastoid, the anterior scalene, the upper trapezius and the splenius capitis muscles.

    Baseline and 5 minutes after treatment

Secondary Outcomes (3)

  • Changes in neck pain intensity with a numerical pain rate scale before and after the intervention

    Baseline and 5 minutes after treatment

  • Changes in widespread pressure pain sensitivity before and after the intervention

    Baseline and 5 minutes after treatment

  • Changes in cervical range of motion before and after the intervention

    Baseline and 5 minutes after treatment

Study Arms (2)

Dry needling

EXPERIMENTAL

Patients will receive dry needling over active trigger points in the upper trapezius muscle

Other: Dry Needling

Manual Therapy

ACTIVE COMPARATOR

Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle

Other: Manual Therapy

Interventions

Patients will receive dry needling over active trigger points in the upper trapezius muscle

Dry needling

Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle

Manual Therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.

You may not qualify if:

  • whiplash injury;
  • previous cervical or thoracic surgery;
  • cervical radiculopathy or myelopathy;
  • diagnosis of fibromyalgia syndrome;
  • having undergone physical therapy in the previous 6 months;
  • less than 18 or greater than 55 years of age
  • fear to needles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Location

Related Publications (1)

  • Rodriguez-Jimenez J, Ortega-Santiago R, Bonilla-Barba L, Falla D, Fernandez-de-Las-Penas C, Florencio LL. Immediate Effects of Dry Needing or Manual Pressure Release of Upper Trapezius Trigger Points on Muscle Activity During the Craniocervical Flexion Test in People with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2022 Sep 30;23(10):1717-1725. doi: 10.1093/pm/pnac034.

MeSH Terms

Conditions

Neck Pain

Interventions

Dry NeedlingMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department

Study Record Dates

First Submitted

December 22, 2018

First Posted

December 26, 2018

Study Start

January 15, 2019

Primary Completion

June 15, 2021

Study Completion

September 1, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations