NCT03331653

Brief Summary

This study will compare the effect of dry needling on the active trigger point on sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and cervical motor control short and medium term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2018

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

November 1, 2017

Last Update Submit

June 12, 2018

Conditions

Keywords

Cervical PainMotor ControlSternocleidomastoidDry Needling

Outcome Measures

Primary Outcomes (2)

  • Cervical Pain

    Changes in the level of Cervical Pain.

    Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month

  • Cervical Motor Control

    Change in the Cervical Motor Control

    Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month

Secondary Outcomes (3)

  • Cervical Range of Movement

    Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month

  • Coordination of superficial and deep cervical flexor muscles

    Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month

  • Cervical Disability

    Pre-intervention,1 month

Study Arms (2)

Dry Needling and Ischemic Compression at the Trigger Point

EXPERIMENTAL

Dry Needling and Ischemic Compression at the Trigger Point

Other: Dry Needling and Ischemic Compression at the Trigger Point

Intervention at 1.5 cm from the Trigger Point

ACTIVE COMPARATOR

Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point

Other: Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point

Interventions

The intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point.

Dry Needling and Ischemic Compression at the Trigger Point

The intervention consist on dry needling at 1.5 centimeters from the active trigger point, and next, do ischemic compression in the same point.

Intervention at 1.5 cm from the Trigger Point

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18 and 65 years old
  • Have pain in the cervical region, which extends from the occipital to the 7th cervical vertebra.
  • Have an active trigger point on the sternocleidomastoid.

You may not qualify if:

  • Present history of trauma in the neck.
  • Present cervical radiculopathy
  • Present a vestibular pathology
  • Previous surgery on the neck or shoulder area
  • Having a primary headache diagnosis
  • Have received dry needling in the neck in the previous 6 months
  • Present cognitive deficit.
  • Be pregnant
  • Taking anticoagulants.
  • Have phobia to the needles (belonephobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alcalá

Alcalá de Henares, Madrid, 28801, Spain

Location

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

  • Aida M. Rodríguez, Physiotherapy

    Investigator

    PRINCIPAL INVESTIGATOR
  • Esther S. Olmo, Physiotherapy

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double-blind, masking the patient and the outcomes assesor. A simple randomization will be performed with Epidat software.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial (RCT) with two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Degree Physiotherapy

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

November 10, 2017

Primary Completion

May 15, 2018

Study Completion

June 10, 2018

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations