- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01290653
Dry Needling Versus Strain-counterstrain on the Upper Trapezius (DNJ)
May 13, 2014 updated by: Eva Segura Ortí, Cardenal Herrera University
Dry Needling Versus Strain Counterstrain Technique: Pilot Study Comparing Effects Over the Upper Trapezius Myofascial Trigger Point
This study investigates the effect of two different techniques (dry needling and Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP).
Subjects with active or latent MTP in this location of the muscle will be identified and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain or placebo manual technique.
Pain pressure threshold, provoked pain, pain at rest, neck disability and electromyography (EMG) activity of the upper trapezius will be registered before and after six sessions of treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
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
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- Universidad CEU Cardenal Herrera
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active myofascial trigger point at the upper trapezius
Exclusion Criteria:
- Diagnosed fibromyalgia
- Cervical radiculopathy
- Facial neuralgia
- Coagulation alteration
- Cancer
- Allergy (included needles)
- History of cervical or shoulder surgery
- History of deep venous thrombosis
- History of myopathy
- History of infiltration at upper trapezius trigger point
- Anticoagulant medication
- Aspirin intake during the last 3 days
- Drug intake (AINES, narcotics, antiepileptics, or any other analgesic medication)
- Pregnancy
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling of trigger point
Deep dry needling will be applied on the upper trapezius myofascial trigger point
|
Deep dry needling until achieving twitch response of the muscle
|
|
Experimental: Strain-counterstraing technique
This manual technique will be applied at the upper trapezius.
|
A manual technique to release tension of painful muscles.
|
|
Placebo Comparator: Placebo manual technique
A technique simulating strain-counterstrain, but without any therapeutic manoeuvre will be applied at the upper trapezius site.
|
A placebo technique, consisting of manual contact of the therapist with the patient without any further therapeutic approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Pressure Threshold
Time Frame: 6 sessions
|
Amount of pressure (Kg/cm2) applied at the myofascial trigger point site that elicit pain for the patient will be reported.
Analogy pressure algometer(Wagner, FPK 20) will be used.
|
6 sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain at rest
Time Frame: 6 sessions
|
Visual Analogue Scale
|
6 sessions
|
|
Neck Disability
Time Frame: 6 sessions
|
Neck Disability Index
|
6 sessions
|
|
Electromyographic activity of the upper trapezius
Time Frame: 6 sessions
|
Surface EMG will be recorded (MP 100 de BIOPAC Systems; Goleta, California, USA).
Electrodes will be located to register activity of the Upper trapezius, according to Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines.
Microvolts of activity at rest will be recorded.
Data will be normalized through calculation of maximal voluntary contraction, so that final data will be reported as a percentage.
|
6 sessions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eva Segura-Ortí, PhD, Cardenal Herrera University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 4, 2011
First Submitted That Met QC Criteria
February 4, 2011
First Posted (Estimate)
February 7, 2011
Study Record Updates
Last Update Posted (Estimate)
May 14, 2014
Last Update Submitted That Met QC Criteria
May 13, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU UCH 203
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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