- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06398574
Effects of Dry Needling on the Behavior of the Shoulder Muscles
Effect of Dry Needling Technique on Shoulder Muscle Functionality in Subjects With and Without Shoulder Pain.
The main objective of this study will be to evaluate the effects of the application of the dry needling technique on the activity of the rotator cuff muscles in the shoulder.
The evaluation of the effects of the application of the dry needling technique will be carried out in subjects with and without shoulder pain.To do this, muscle strength, possible thickness changes in the muscle and electromyographic activity will be measured before and immediately after the application of a dry needling technique.
Likewise, other variables will be measured such as the pressure pain threshold (PPT), pain with a Numeric Verbal Scale, kinesiophobia and catastrophism, the shoulder pain and disability index (SPADI) and the influence of expectations about dry needling.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marina Ortega-Santamaria, PhD student
- Phone Number: (+34) 683 378 391
- Email: marinaortegasantamaria@gmail.com
Study Contact Backup
- Name: Centro Investigacion Fisioterapia y Dolor
Study Locations
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Madrid
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Alcalá de Henares, Madrid, Spain, 2805
- Recruiting
- Clinical University Physiotherapy and pain
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Contact:
- Patricia Martinez-Merinero, PhD
- Phone Number: 683378391
- Email: info@fisioneuromusculoesqueletica.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects of legal age
- Subjects without shoulder pain or with unilateral shoulder pain of > 3 months duration.
- Have shoulder mobility of 90º of abduction and at least 30º of glenohumeral external rotation.
Exclusion Criteria:
- Have neck pain.
- Whiplash
- Having had trauma to the shoulder.
- Having fibromyalgia.
- Be pregnant.
- Being afraid of needles.
Study Plan
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: Real dry needling
With the subject lying supine, a dry needling technique will be applied to the infraspinatus muscle.
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With the subject lying supine, a dry needling technique will be applied to the infraspinatus muscle.
First, the most hyperalgesic point in the muscle will be located.
Subsequently, Hong's fast-in and fast-out technique will be applied.
Ten incisions will be made
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Sham Comparator: Sham dry needling
With the subject lying supine, a sham dry needling technique will be applied to the infraspinatus muscle, simulating the real procedure.
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With the subject lying supine, a sham dry needling technique will be applied to the infraspinatus muscle.
First, the most hyperalgesic point in the muscle will be located.
Subsequently, Hong's fast-in and fast-out technique will be applied.
Ten incisions will be made, simulating the real technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: Change from Baseline at 15 minutes.
|
The isometric strength will be assessed using a handheld dynamometer (Hand held dynamometer, MicroFET3; Hoggan Health Industries Inc.).
The strength measures will included external rotation at 90° abduction in the prone position.
The dynamometer will be placed just proximal to the just proximal to the styloid process of the wrist joint.
Subjects will be asked to produce a 5-second maximal contraction.
Muscular strength will be measured in kilograms
|
Change from Baseline at 15 minutes.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle function
Time Frame: Change from Baseline at 15 minutes.
|
Muscle function will be measured by an ultrasound scanner with a linear transducer with a frequency range of 6-16MHz (X6-16L, 5cm footprint) will be used.
The unit of measurement used will be millimeters.
Muscle thickness at rest and contraction will be measured.
On the other hand, the percentage of change in thickness will be measured using the equation (Contraction thickness - Rest thickness) * 100 / Rest thickness.
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Change from Baseline at 15 minutes.
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Shoulder Pain
Time Frame: Change from Baseline at 15 minutes.
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Pain intensity will be measured using the Visual Analog Scale (VAS) for pain.
The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain."
Subjects will be asked to rate their current pain with a mark on the scale.
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Change from Baseline at 15 minutes.
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Disability
Time Frame: Change from Baseline at 15 minutes.
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Disability will be measured by Shoulder Pain and Disability Index (SPADI).The Spanish version of SPADI has high test-retest reliability (ICC 0.89-0.93).The clinically important minimum difference varies between 8 and 13.2.
The minimum value is 0 and de maximum value is 100
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Change from Baseline at 15 minutes.
|
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Pressure Pain Threshold (PPT)
Time Frame: Change from Baseline at 15 minutes.
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An algometer Wagner FPI 10-WA will be used to determine the PPT in infraespinatus muscle.
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Change from Baseline at 15 minutes.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Daniel Pecos-Martin, PhD, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEID/2024/1/004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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