Effectiveness of US-PENS for Patients With Post-surgical Shoulder Pain

March 23, 2024 updated by: Mario Jesus Abril Servan, Universidad Rey Juan Carlos

Effectiveness of Ultrasound-guied Percutaneous Electrical Nerve Stimulation (US-PENS) for Patients With Post-surgical Shoulder Pain.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28049
        • Recruiting
        • Clinica Cemtro
        • Contact:
        • Contact:
        • Principal Investigator:
          • MARIO J ABRIL SERVÁN
        • Sub-Investigator:
          • ADRIÁN CASES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided percutaneous nerve stimulation (US-PENS) and physiotherapy protocol.
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.
Intervention performed by needling in the vicinity of the peripheral nerves of the shoulder under ultrasound-guided control.
Active Comparator: Physiotherapy protocol.
Only a physiotherapy protocol based on available evidence, applied to patients with pain undergoing shoulder surgery.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 WEEKS
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).
12 WEEKS
The Shoulder Pain and Disability Index (SPADI)
Time Frame: 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.
12 WEEKS
GONIOMETRY
Time Frame: 12 WEEKS
Measuring the joint ranges in each plane of the joint.
12 WEEKS
DINAMOMETRY
Time Frame: 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.
12 WEEKS
PAIN THRESHOLD ON PRESSURE
Time Frame: 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.
12 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Rey Juan Carlos

Investigators

  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

March 23, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004202111621

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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