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

Not Applicable

Completed

• Conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation
• Interventions: Procedure: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence.; Procedure: Manual physiotherapy protocol based on available evidence.

• Registration Number: NCT06331871
• Lead Sponsor: Universidad Rey Juan Carlos

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.

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.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-02-24
• Study First Submitted QC: 2024-03-23
• Study First Posted: 2024-03-26
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided percutaneous nerve stimulation (US-PENS) and physiotherapy protocol.	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.	Manual physiotherapy protocol based on available evidence.	Only a physiotherapy protocol based on available evidence, applied to patients with pain undergoing shoulder surgery.

Primary Outcome Measures

Name	Time	Method
DINAMOMETRY	12 WEEKS	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.
PAIN THRESHOLD ON PRESSURE	12 WEEKS	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.
The Numeric Pain Rating Scale (NPRS)	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)	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).
The Shoulder Pain and Disability Index (SPADI)	12 WEEKS	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.
GONIOMETRY	12 WEEKS	Measuring the joint ranges in each plane of the joint.

Trial Locations

Locations (1)

Clinica Cemtro; 🇪🇸 Madrid, Spain