Effects of Dry Needling on the Behavior of the Shoulder Muscles

Shoulder Pain Clinical Trial

Official title:

Effect of Dry Needling Technique on Shoulder Muscle Functionality in Subjects With and Without Shoulder Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398574
• Other study ID #: CEID/2024/1/004
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: May 2024
• Source: University of Alcala
• Contact: Marina Ortega-Santamaria, PhD student
• Phone: (+34) 683 378 391
• Email: marinaortegasantamaria[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Real 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
• Sham dry needling
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

Locations

Country	Name	City	State
Spain	Clinical University Physiotherapy and pain	Alcala de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline at 15 minutes.
Secondary	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.	Change from Baseline at 15 minutes.
Secondary	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.	Change from Baseline at 15 minutes.
Secondary	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	Change from Baseline at 15 minutes.
Secondary	Pressure Pain Threshold (PPT)	An algometer Wagner FPI 10-WA will be used to determine the PPT in infraespinatus muscle.	Change from Baseline at 15 minutes.