NCT06398574

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
May 2024Dec 2026

First Submitted

Initial submission to the registry

May 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

May 1, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

Dry needlingShoulder muscle strengthSurface electromyography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Muscle function

    Change from Baseline at 15 minutes.

  • Shoulder Pain

    Change from Baseline at 15 minutes.

  • Disability

    Change from Baseline at 15 minutes.

  • Pressure Pain Threshold (PPT)

    Change from Baseline at 15 minutes.

Study Arms (2)

Real dry needling

EXPERIMENTAL

With the subject lying supine, a dry needling technique will be applied to the infraspinatus muscle.

Other: Real dry needling

Sham dry needling

SHAM COMPARATOR

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

Interventions

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

Real 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

Sham dry needling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have neck pain.
  • Whiplash
  • Having had trauma to the shoulder.
  • Having fibromyalgia.
  • Be pregnant.
  • Being afraid of needles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical University Physiotherapy and pain

Alcalá de Henares, Madrid, 2805, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Pecos-Martin, PhD

    Alcala University

    STUDY CHAIR

Central Study Contacts

Marina Ortega-Santamaria, PhD student

CONTACT

Centro Investigacion Fisioterapia y Dolor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 3, 2024

Study Start

May 6, 2024

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations