Shoulder PainNCT06398574
Effects of Dry Needling on the Behavior of the Shoulder Muscles
A study testing Real dry needling in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Real dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have neck pain.
- Whiplash
- Having had trauma to the shoulder.
- Having fibromyalgia.
- Be pregnant.
- Being afraid of needles.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Centro Investigacion Fisioterapia y Dolor contact
Spain1 site, 1 recruiting
- Recruiting
Clinical University Physiotherapy and pain
Alcalá de Henares, Madrid, 2805
Patricia Martinez-Merinero, PhD, 683378391, info@fisioneuromusculoesqueletica.com
About this study
Official title: 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.
- Conditions
- Shoulder Pain
- Being tested
- Real dry needling, Sham dry needling
- Keywords
- Dry needling, Shoulder muscle strength, Surface electromyography
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real dry needlingOther
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 needlingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Real dry needling | Experimental | With the subject lying supine, a dry needling technique will be applied to the infraspinatus muscle. Receives: 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. Receives: Other: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline at 15 minutes.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Change from Baseline at 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 May 2024
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398574
- Sponsor's protocol ID
- CEID/2024/1/004
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Needling Technique on Shoulder Muscle Functionality in Subjects With and Without Shoulder Pain.
- ClinicalTrials.gov ID
- NCT06398574
- Acronym / sponsor ID
- CEID/2024/1/004
- Conditions
- Shoulder Pain
- Keywords
- Dry needling, Shoulder muscle strength, Surface electromyography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real dry needling | Experimental | Other: Real dry needlingWith the subject lying supine, a dry needling technique will be applied to the infraspinatus muscle. |
| Sham dry needling | Sham comparator | Other: Sham dry needlingWith the subject lying supine, a sham dry needling technique will be applied to the infraspinatus muscle, simulating the real procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Have neck pain.
- Whiplash
- Having had trauma to the shoulder.
- Having fibromyalgia.
- Be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real dry needlingWith 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 | Other | Real dry needling |
| Sham dry needlingWith 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 | Other | Sham dry needling |
Primary outcome
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
4 secondary outcomes
Muscle function
Time frame: Change from Baseline at 15 minutes.
Shoulder Pain
Time frame: Change from Baseline at 15 minutes.
Disability
Time frame: Change from Baseline at 15 minutes.
Pressure Pain Threshold (PPT)
Time frame: Change from Baseline at 15 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centro Investigacion Fisioterapia y Dolor contact
Daniel Pecos-Martin, PhD study chair
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real dry needling in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Ortega-Santamaria, PhD student ((+34) 683 378 391, marinaortegasantamaria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Change from Baseline at 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.