NCT03762252

Brief Summary

There is preliminary evidence suggesting that referred pain from active trigger points can play a relevant role in individuals with mechanical neck pain. Some studies have investigated the effectiveness of dry needling over the upper trapezius muscle in this population. However, other muscles, such as the scalene muscles, can be also relevant for neck pain symptoms. No study has investigated the effects of the application of dry needling over active trigger points in the scalenes muscles in a sample of patients with mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

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

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

November 30, 2018

Last Update Submit

July 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

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

    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity

    Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention

Secondary Outcomes (3)

  • Changes in oxigen saturation with a pulse oximeter before and after the intervention

    Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention

  • Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention

    Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention

  • Changes in neck-related disability with the Neck Disability Index before and after the intervention

    Baseline and 7 days (one week) and 30 days (one month) after the intervention

Study Arms (2)

Dry needling

EXPERIMENTAL

Patients will receive dry needling over active trigger points in the scalene muscles

Other: Dry needling

Manual Therapy

ACTIVE COMPARATOR

Patients will receive a manual compression for 30seconds over active trigger points in the scalene muscles

Other: Manual Therapy

Interventions

A solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles.

Dry needling

The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds

Manual Therapy

Eligibility Criteria

Age18 Years - 45 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 45 years of age
  • fear to needles
  • any respiratory disease, e.g., chronic brochitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

César Fernández-de-las-Peñas

Alcorcón, Madrid, 28922, Spain

Location

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 Officials

  • César Fernández-de-las-Peñas

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

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

November 30, 2018

First Posted

December 3, 2018

Study Start

December 5, 2018

Primary Completion

May 15, 2019

Study Completion

July 1, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations