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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06331871
Enrollment
70
Registered
2024-03-26
Start date
2023-11-01
Completion date
2025-03-26
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound-Guided Percutaneous Electrical Nerve Stimulation

Keywords

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

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.

Interventions

PROCEDUREUltrasound 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.

PROCEDUREManual physiotherapy protocol based on available evidence.

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

Sponsors

Universidad Rey Juan Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Numeric Pain Rating Scale (NPRS)12 WEEKSThe 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 WEEKSThis 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).

Secondary

MeasureTime frameDescription
The Shoulder Pain and Disability Index (SPADI)12 WEEKSThe 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.
GONIOMETRY12 WEEKSMeasuring the joint ranges in each plane of the joint.
DINAMOMETRY12 WEEKSassessment 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.
PRESSURE PAIN THRESHOLD12 WEEKSThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026