Ultrasound-Guided Percutaneous Electrical Nerve StimulationNCT06331871

Effectiveness of Ultrasound-Guided Nerve Stimulation for Patients With Post-surgical Shoulder Pain

A study testing Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. and Manual physiotherapy protocol based on available evidence. in people with Ultrasound-Guided Percutaneous Electrical Nerve Stimulation, run by Universidad Rey Juan Carlos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (US-PENS) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation
What is being tested?: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. and Manual physiotherapy protocol based on available evidence.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteSpain
Study dates: 1 Nov 2023to 26 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing surgery using arthroscopic techniques for rotator cuff repair, shoulder instability injuries or arthrolysis;
Be between the 4th and 6th week after surgery;
Presence of pain and restriction in shoulder joint mobility in at least one of the movements analyzed after surgery;
Patients without previous surgery on the shoulder girdle.

Who cannot join

Having undergone previous physiotherapy treatment for the same reason;
Having undergone previous physiotherapy treatment for the same reason;
Belonephobia and/or electrophobia;
Pharmacological treatment with antiplatelet agents;
Patients infiltrated with corticosteroids and/or anesthetics after surgery.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Clinica Cemtro
Madrid, Madrid, 28049

Other trials in Spain

About this study

Official title: Effectiveness of Ultrasound-Guided Percutaneous Electrical Nerve Stimulation (PENS) for Patients With Post-surgical Shoulder Pain: A Randomized Clinical Trial

This is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a US-PENS session was added (n=35).

The intervention and follow-up period of the participants took place over 12 weeks.

Read the detailed description

The objective of this clinical trial is to evaluate the effects of including ultrasound-guided percutaneous nerve stimulation (US-PENS) on the suprascapular nerve and axillary nerve, along with a manual physical therapy protocol in patients with pain and lack of function after a shoulder surgery.

Methods: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited.

They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of US-PENS were added (n=35).

A series of variables were evaluated:

Pain, disability and functional impotence with the help of the NSPR, SPADI and DASH scales.

In turn, goniometry, dynamometry and calculation of the pressure pain threshold were performed.

The intervention and follow-up period of the participants lasted 12 weeks.

Conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation
Being tested: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence., Manual physiotherapy protocol based on available evidence.
Keywords: PENS, Ultrasound, Axilar nerve, Supraescapular nerve, Shoulder, Postsurgery pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence.Procedure or surgery
Intervention performed by needling in the vicinity of the peripheral nerves of the shoulder under ultrasound-guided control.
Manual physiotherapy protocol based on available evidence.Procedure or surgery
Physiotherapy treatment based on the best scientific evidence available, based on manual therapy and passive and active kinesitherapy

Study groups in NCT06331871
Study group	Role	What they receive
Ultrasound-guided percutaneous nerve stimulation (US-PENS) and physiotherapy protocol.	Experimental	Ultrasound Guied Percutaneus Electrical Nerve Stimulation on the suprascapular nerve and axillary nerve, along with a manual physical therapy protocol in patients with pain and lack of function after a shoulder surgery. Receives: Procedure: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence.
Physiotherapy protocol.	Active comparator	Only a physiotherapy protocol based on available evidence, applied to patients with pain undergoing shoulder surgery. Receives: Procedure: Manual physiotherapy protocol based on available evidence.

What is being measured

The primary outcome is the main question the study is designed to answer.

The Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional, outcome measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
The NPRS is a segmented numerical version of the visual analog scale (VAS) in which a respondent selects a whole number between zero and ten that best reflects the intensity of their pain.
The common format is a horizontal bar or line, and like the VAS, the NPRS is based on terms that describe the extremes of pain severity.
Therefore, the numerical rating scale consists of 11 points (NPRS), where values close to 0 reflect less pain and values close to 10 reflect greater pain.
Measured: 12 WEEKS
Disabilities of the Arm, Shoulder and Hand (DASH)
This is a questionnaire that determines the degree of disability in the arm, shoulder and hand, providing the evaluator with a specific outcome measure of the upper extremity.
The questionnaire consists of 30 questions that are divided into several items: 21 of them evaluate a module on physical status, 6 on painful symptoms, and 3 final questions explore the patient's social environment. The sum of the scores for each of the items is used to calculate a final value that ranges from 0 (no disability) to 100 (most severe disability).
Measured: 12 WEEKS

Secondary outcomes (4)

The Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) was developed to measure shoulder pain and disability in both primary care with mixed diagnosis and surgical patient populations, including rotator cuff injuries, adhesive capsulitis, replacement surgery or shoulder prosthesis and in a large population study of painful shoulder symptoms.
SPADI is a self-completed questionnaire with 13 items that evaluate the level of pain and the degree of difficulty with activities of daily living in the use of the upper extremities. The pain subscale is made up of 5 items and the disability subscale is made up of 8.
The reliability of SPADI provides an average intraclass correlation coefficient of 0.89 (ICC 0.66-0.95) and a 95% CI. A Spanish version is available that demonstrated satisfactory psychometrics in populations with different shoulder disorders.
Measured: 12 WEEKS
GONIOMETRY
Measuring the joint ranges in each plane of the joint.
Measured: 12 WEEKS
DINAMOMETRY
assessment of muscle strength has been and is a necessity in the physiotherapy diagnosis process. Knowing this physical capacity allows us to evaluate the functional state of a muscle and, in turn, locate dysfunctions and quantify the improvement in recovery processes.
Measured: 12 WEEKS
PRESSURE PAIN THRESHOLD
The pressure pain threshold is defined as the amount of pressure applied to a point on a subject who is first experiencing a change from the sensation of pressure to the sensation of pain.
Measured: 12 WEEKS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202326 Mar 2025

First posted26 Mar 2024
Study start1 Nov 2023
Primary completion25 Mar 2025
Study completion26 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ultrasound-Guided Percutaneous Electrical Nerve StimulationStudies 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
Model description: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited. They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of ultrasound-guided percutaneous nerve stimulation (US-PENS) were added (n=35).
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06331871
Sponsor's protocol ID: 2004202111621
Status last verified: Nov 2025
First submitted: 24 Feb 2024
Last updated: 25 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ultrasound-Guided Percutaneous Electrical Nerve Stimulation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Ultrasound-Guided Percutaneous Electrical Nerve Stimulation (PENS) for Patients With Post-surgical Shoulder Pain: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06331871
Acronym / sponsor ID: 2004202111621
Conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation
Keywords: PENS, Ultrasound, Axilar nerve, Supraescapular nerve, Shoulder, Postsurgery pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Universidad Rey Juan CarlosUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 25 Mar 2025 (actual)
Study completion: 26 Mar 2025 (actual)
First posted: 26 Mar 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 intervention and follow-up period of the participants took place over 12 weeks.

Detailed description

Methods: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited.

They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of US-PENS were added (n=35).

A series of variables were evaluated:

Pain, disability and functional impotence with the help of the NSPR, SPADI and DASH scales.

In turn, goniometry, dynamometry and calculation of the pressure pain threshold were performed.

The intervention and follow-up period of the participants lasted 12 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited. They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of ultrasound-guided percutaneous nerve stimulation (US-PENS) were added (n=35).

Arm	Type	Receives
Ultrasound-guided percutaneous nerve stimulation (US-PENS) and physiotherapy protocol.	Experimental	Procedure: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence.Ultrasound Guied Percutaneus Electrical Nerve Stimulation on the suprascapular nerve and axillary nerve, along with a manual physical therapy protocol in patients with pain and lack of function after a shoulder surgery.
Physiotherapy protocol.	Active comparator	Procedure: Manual physiotherapy protocol based on available evidence.Only a physiotherapy protocol based on available evidence, applied to patients with pain undergoing shoulder surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients undergoing surgery using arthroscopic techniques for rotator cuff repair, shoulder instability injuries or arthrolysis;
Be between the 4th and 6th week after surgery;
Presence of pain and restriction in shoulder joint mobility in at least one of the movements analyzed after surgery;
Patients without previous surgery on the shoulder girdle.

Key exclusion criteria (5 listed)

Having undergone previous physiotherapy treatment for the same reason;
Having undergone previous physiotherapy treatment for the same reason;
Belonephobia and/or electrophobia;
Pharmacological treatment with antiplatelet agents;
Patients infiltrated with corticosteroids and/or anesthetics after surgery.

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
Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence.Intervention performed by needling in the vicinity of the peripheral nerves of the shoulder under ultrasound-guided control.	Procedure or surgery	Ultrasound-guided percutaneous nerve stimulation (US-PENS) and physiotherapy protocol.
Manual physiotherapy protocol based on available evidence.Physiotherapy treatment based on the best scientific evidence available, based on manual therapy and passive and active kinesitherapy	Procedure or surgery	Physiotherapy protocol.

Primary outcome

The Numeric Pain Rating Scale (NPRS)
Time frame: 12 WEEKS
The Numeric Pain Rating Scale (NPRS) is a unidimensional, outcome measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. The NPRS is a segmented numerical version of the visual analog scale (VAS) in which a respondent selects a whole number between zero and ten that best reflects the intensity of their pain. The common format is a horizontal bar or line, and like the VAS, the NPRS is based on terms that describe the extremes of pain severity. Therefore, the numerical rating scale consists of 11 points (NPRS), where values close to 0 reflect less pain and values close to 10 reflect greater pain.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 12 WEEKS
This is a questionnaire that determines the degree of disability in the arm, shoulder and hand, providing the evaluator with a specific outcome measure of the upper extremity. The questionnaire consists of 30 questions that are divided into several items: 21 of them evaluate a module on physical status, 6 on painful symptoms, and 3 final questions explore the patient's social environment. The sum of the scores for each of the items is used to calculate a final value that ranges from 0 (no disability) to 100 (most severe disability).

4 secondary outcomes

The Shoulder Pain and Disability Index (SPADI)
Time frame: 12 WEEKS
GONIOMETRY
Time frame: 12 WEEKS
DINAMOMETRY
Time frame: 12 WEEKS
PRESSURE PAIN THRESHOLD
Time frame: 12 WEEKS

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.

Related trials for Ultrasound-Guided Percutaneous Electrical Nerve Stimulation

Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
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Recruiting
TENS During Transperineal Prostate Biopsy
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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. This study is not recruiting at the moment.

JOSE LU ARIAS BURIA study director

Fisioterapia, Terapia Ocupacional, Rehabilitación y Medicina Física/URJC/ Fac. de CC. de la Salud

CESAR FERNÁNDEZ DE LAS PEÑAS study director

Fisioterapia, Terapia Ocupacional, Rehabilitación y Medicina Física/URJC/ Fac. de CC. de la Salud

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Nov 2025. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Numeric Pain Rating Scale (NPRS) (time frame: 12 WEEKS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06331871.

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 25 Nov 2025.