Dry Needling of Scalene Muscle Trigger Points in Mechanical Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Manual Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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
Sites / Locations
- César Fernández-de-las-Peñas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry needling
Manual Therapy
Arm Description
Patients will receive dry needling over active trigger points in the scalene muscles
Patients will receive a manual compression for 30seconds over active trigger points in the scalene muscles
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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®
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
Full Information
NCT ID
NCT03762252
First Posted
November 30, 2018
Last Updated
July 7, 2019
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03762252
Brief Title
Dry Needling of Scalene Muscle Trigger Points in Mechanical Neck Pain
Official Title
Effects of Dry Needling of Active Trigger Points in the Scalene Muscles on Individuals With Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Patients will receive dry needling over active trigger points in the scalene muscles
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
Patients will receive a manual compression for 30seconds over active trigger points in the scalene muscles
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds
Primary Outcome Measure Information:
Title
Changes in neck pain intensity with a numerical pain rate scale before and after the intervention
Description
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity
Time Frame
Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Secondary Outcome Measure Information:
Title
Changes in oxigen saturation with a pulse oximeter before and after the intervention
Description
Oxygen saturation will be monitored with a handheld pulse oximeter with Masimo SET® measure-through Motion and Low Perfusion™ pulse oximeter
Time Frame
Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Title
Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention
Description
Changes in inspiratory vital capacity will be assessed with the incentive spirometer DHD Coach 2®
Time Frame
Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Title
Changes in neck-related disability with the Neck Disability Index before and after the intervention
Description
The Neck Disability Index (NDI, 0-50), a specific neck pain related disability questionaire, will be used for assessing neck pain related-disability
Time Frame
Baseline and 7 days (one week) and 30 days (one month) after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Fernández-de-las-Peñas
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
César Fernández-de-las-Peñas
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Dry Needling of Scalene Muscle Trigger Points in Mechanical Neck Pain
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