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NCT Number: NCT06398574

Effects of Dry Needling on the Behavior of the Shoulder Muscles

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical University Physiotherapy and pain

Alcalá de Henares, Madrid, 2805, Spain

Location status: Recruiting

Location contact

Patricia Martinez-Merinero, PhD

CONTACT

[email protected]

683378391

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real dry needling

Other

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

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Shoulder Pain

    Time frame: Change from Baseline at 15 minutes.

    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.

  3. Disability

    Time frame: Change from Baseline at 15 minutes.

    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

  4. Pressure Pain Threshold (PPT)

    Time frame: Change from Baseline at 15 minutes.

    An algometer Wagner FPI 10-WA will be used to determine the PPT in infraespinatus muscle.

Study contacts

Contact information is provided by the study sponsor or research team.

Centro Investigacion Fisioterapia y Dolor

CONTACT

Marina Ortega-Santamaria, PhD student

CONTACT

[email protected]

(+34) 683 378 391

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 3, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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