- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331653
Effectiveness of Dry Needling and Ischemic Compression in Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain.
June 12, 2018 updated by: Aida Martín Rodríguez, University of Alcala
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.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28801
- University of Alcalá
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling and Ischemic Compression at the Trigger Point
|
The intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point.
|
|
Active Comparator: Intervention at 1.5 cm from the Trigger Point
Dry Needling and Ischemic Compression at 1.5 centimeters from 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Pain
Time Frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
Changes in the level of Cervical Pain.
|
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
|
Cervical Motor Control
Time Frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
Change in the Cervical Motor Control
|
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Movement
Time Frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
Changes in grades of cervical movement
|
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
|
Coordination of superficial and deep cervical flexor muscles
Time Frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
Changes in the coordination of cervical flexor muscles
|
Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
|
|
Cervical Disability
Time Frame: Pre-intervention,1 month
|
Changes in perceived cervical disability
|
Pre-intervention,1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aida M. Rodríguez, Physiotherapy, Investigator
- Principal Investigator: Esther S. Olmo, Physiotherapy, Investigator
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2017
Primary Completion (Actual)
May 15, 2018
Study Completion (Actual)
June 10, 2018
Study Registration Dates
First Submitted
November 1, 2017
First Submitted That Met QC Criteria
November 1, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
June 13, 2018
Last Update Submitted That Met QC Criteria
June 12, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/HU/2017/15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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