Effectiveness of Ultrasound-Guided Percutaneous Electrical Nerve Stimulation (PENS) for Patients With Post-surgical Shoulder Pain: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad Rey Juan Carlos
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- The Numeric Pain Rating Scale (NPRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. (Procedure)
Physiotherapy protocol.
Only a physiotherapy protocol based on available evidence, applied to patients with pain undergoing shoulder surgery.
Intervention: Manual physiotherapy protocol based on available evidence. (Procedure)
Outcomes
Primary Outcomes
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.
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).
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.
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).
Secondary Outcomes
- The Shoulder Pain and Disability Index (SPADI)(12 WEEKS)
- GONIOMETRY(12 WEEKS)
- DINAMOMETRY(12 WEEKS)
- PRESSURE PAIN THRESHOLD(12 WEEKS)
Investigators
Mario Jesus Abril Servan
Principal Investigator
Universidad Rey Juan Carlos