An interventional study of Real dry needling and Sham dry needling in Shoulder Pain, sponsored by University of Alcala. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Alcala · Not applicable, Interventional, and Treatment
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.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 587 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
With the subject lying supine, a dry needling technique will be applied to the infraspinatus muscle.
Other: Real dry needling
With the subject lying supine, a sham dry needling technique will be applied to the infraspinatus muscle, simulating the real procedure.
Other: Sham dry needling
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
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
Muscle strength
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
Time frame: Change from Baseline at 15 minutes.
Muscle function
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.
Time frame: Change from Baseline at 15 minutes.
Shoulder Pain
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.
Time frame: Change from Baseline at 15 minutes.
Disability
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
Time frame: Change from Baseline at 15 minutes.
Pressure Pain Threshold (PPT)
An algometer Wagner FPI 10-WA will be used to determine the PPT in infraespinatus muscle.
Time frame: Change from Baseline at 15 minutes.
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 31 months is above that.
Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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