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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762252
Other study ID # URJC 2018-12-10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2018
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Universidad Rey Juan Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dry needling
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.
Manual Therapy
The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds

Locations

Country Name City State
Spain César Fernández-de-las-Peñas Alcorcón Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in oxigen saturation with a pulse oximeter before and after the intervention Oxygen saturation will be monitored with a handheld pulse oximeter with Masimo SET® measure-through Motion and Low Perfusion™ pulse oximeter Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Secondary Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention Changes in inspiratory vital capacity will be assessed with the incentive spirometer DHD Coach 2® Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Secondary Changes in neck-related disability with the Neck Disability Index before and after the intervention The Neck Disability Index (NDI, 0-50), a specific neck pain related disability questionaire, will be used for assessing neck pain related-disability Baseline and 7 days (one week) and 30 days (one month) after the intervention
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