Clinical trial NCT06331871: Effectiveness of Ultrasound-Guided Nerve Stimulation for Patients With Post-surgical Shoulder Pain
Official title: Effectiveness of Ultrasound-Guided Percutaneous Electrical Nerve Stimulation (PENS) for Patients With Post-surgical Shoulder Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation
Keywords: PENS
Ultrasound
Axilar nerve
Supraescapular nerve
Shoulder
Postsurgery pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Numeric Pain Rating Scale (NPRS)
timeFrame: 12 WEEKS
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 12 WEEKS
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 12 WEEKS
measure: GONIOMETRY
timeFrame: 12 WEEKS
measure: DINAMOMETRY
timeFrame: 12 WEEKS
measure: PAIN THRESHOLD ON PRESSURE
timeFrame: 12 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinica Cemtro
Study officials:
affiliation: Fisioterapia, Terapia Ocupacional, Rehabilitación y Medicina Física/URJC/ Fac. de CC. de la Salud
name: JOSE LU ARIAS BURIA
role: STUDY_DIRECTOR
affiliation: Fisioterapia, Terapia Ocupacional, Rehabilitación y Medicina Física/URJC/ Fac. de CC. de la Salud
name: CESAR FERNÁNDEZ DE LAS PEÑAS
role: STUDY_DIRECTOR
References: