Back to resultsEffectiveness of Dry Needling and Ischemic Compression in Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain.
Primary Purpose
Cervical Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling and Ischemic Compression at the Trigger Point
Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Pain focused on measuring Cervical Pain, Motor Control, Sternocleidomastoid, Dry Needling
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- University of Alcalá
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry Needling and Ischemic Compression at the Trigger Point
Intervention at 1.5 cm from the Trigger Point
Arm Description
Dry Needling and Ischemic Compression at the Trigger Point
Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
Outcomes
Primary Outcome Measures
Cervical Pain
Changes in the level of Cervical Pain.
Cervical Motor Control
Change in the Cervical Motor Control
Secondary Outcome Measures
Cervical Range of Movement
Changes in grades of cervical movement
Coordination of superficial and deep cervical flexor muscles
Changes in the coordination of cervical flexor muscles
Cervical Disability
Changes in perceived cervical disability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03331653
Brief Title
Effectiveness of Dry Needling and Ischemic Compression in Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain.
Official Title
Effectiveness of Dry Needling and Ischemic Compression in the Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain, Versus Placebo Technique and Ischemic Compression, Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
June 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain
Keywords
Cervical Pain, Motor Control, Sternocleidomastoid, Dry Needling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial (RCT) with two groups.
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind, masking the patient and the outcomes assesor. A simple randomization will be performed with Epidat software.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Needling and Ischemic Compression at the Trigger Point
Arm Type
Experimental
Arm Description
Dry Needling and Ischemic Compression at the Trigger Point
Arm Title
Intervention at 1.5 cm from the Trigger Point
Arm Type
Active Comparator
Arm Description
Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
Intervention Type
Other
Intervention Name(s)
Dry Needling and Ischemic Compression at the Trigger Point
Intervention Description
The intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point.
Intervention Type
Other
Intervention Name(s)
Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
Intervention Description
The intervention consist on dry needling at 1.5 centimeters from the active trigger point, and next, do ischemic compression in the same point.
Primary Outcome Measure Information:
Title
Cervical Pain
Description
Changes in the level of Cervical Pain.
Time Frame
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Title
Cervical Motor Control
Description
Change in the Cervical Motor Control
Time Frame
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Secondary Outcome Measure Information:
Title
Cervical Range of Movement
Description
Changes in grades of cervical movement
Time Frame
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Title
Coordination of superficial and deep cervical flexor muscles
Description
Changes in the coordination of cervical flexor muscles
Time Frame
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Title
Cervical Disability
Description
Changes in perceived cervical disability
Time Frame
Pre-intervention,1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aida M. Rodríguez, Physiotherapy
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esther S. Olmo, Physiotherapy
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alcalá
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain
12. IPD Sharing Statement
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Effectiveness of Dry Needling and Ischemic Compression in Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain.
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