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

NCT06331871 | Completed

• 1 other identifier: 2004202111621
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ultrasound-Guided Percutaneous Electrical Nerve Stimulation

Keywords

PENS; Ultrasound; Axilar nerve; Supraescapular nerve; Shoulder; Postsurgery pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  12 WEEKS

Secondary Outcomes (4)

• The Shoulder Pain and Disability Index (SPADI)

  12 WEEKS

• GONIOMETRY

  12 WEEKS

• DINAMOMETRY

  12 WEEKS

• PRESSURE PAIN THRESHOLD

  12 WEEKS

Study Arms (2)

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.

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.

Procedure: Manual physiotherapy protocol based on available evidence.

Interventions

Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. PROCEDURE

Intervention performed by needling in the vicinity of the peripheral nerves of the shoulder under ultrasound-guided control.

Ultrasound-guided percutaneous nerve stimulation (US-PENS) and physiotherapy protocol.

Manual physiotherapy protocol based on available evidence. PROCEDURE

Physiotherapy treatment based on the best scientific evidence available, based on manual therapy and passive and active kinesitherapy

Physiotherapy protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Clinica Cemtro

Madrid, Madrid, 28049, Spain

Location

Study Officials

• JOSE LU ARIAS BURIA

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

  STUDY DIRECTOR

• CESAR FERNÁNDEZ DE LAS PEÑAS

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 26, 2024
• Study Start: November 1, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 26, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

ES (1)