Back to resultsEffect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty
Primary Purpose
Rotator Cuff Tear Arthropathy, Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
supraescapular nerve radiofrequency
interescalenic braquial plexus
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Arthropathy focused on measuring rotator cuff arthropathy, reverse shoulder arthroplasty, supraescapular nerve radiofrecuency, post operative pain
Eligibility Criteria
Inclusion criteria: Over 18 y.o. Cronic pain (more than 3 months) due to rotator cuff arthropathy VAS higher than 4 Decrease Constant score Conservative treatment (physiotherapy and NSAIs) unsuccessful Exclusion criteria: psychiatric illness drug abuse. previous surgeries. acute traumatic pathology or ethiology different from rotator cuff arthropathy pacemaker infectious process
Sites / Locations
- Hospital Universitario Virgen MacarenaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radiofrequency group
Interscalenic braquial plexus block group
Arm Description
Patient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery
Interscalenic braquial plexus block done at the moment of the surgery.
Outcomes
Primary Outcome Measures
Visual analogical scale
Postoperative acute pain measurement. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
Secondary Outcome Measures
Visual analogical scale
chronic pain after surgery. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
Full Information
NCT ID
NCT05785572
First Posted
March 15, 2023
Last Updated
April 5, 2023
Sponsor
Hospital Universitario Virgen Macarena
1. Study Identification
Unique Protocol Identification Number
NCT05785572
Brief Title
Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty
Official Title
Study on the of Preoperative Analgesia With Radiofrequency of Suprascapular Nerve Versus Intraoperative Interscalene Block on Postoperative Pain in Shoulder Rerverse Arthroplasty Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Virgen Macarena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpuse of this study is to asses if the pulsed radiofrecuency of the supraescapular nerve and accesory nerve have the same or superior efectivity controlling the acute postoperative pain than interscalenic braquial plexus block
Detailed Description
This is a randomized, double-blind trial that compares the effect in postoperative pain of pulsed radiofrecuency of the supraescapular nerve carried out at least two to four weeks before reverse total shoulder arthroplasty surgery with interscalenic braquial plexus block done at the moment of the surgery. All the patients received conventional general anaesthesia and multimodal postoperative analgesia with additional patient-controlled rescue analgesics were prescribed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy, Post Operative Pain
Keywords
rotator cuff arthropathy, reverse shoulder arthroplasty, supraescapular nerve radiofrecuency, post operative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial with two groups of study
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Double blind trial
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency group
Arm Type
Experimental
Arm Description
Patient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery
Arm Title
Interscalenic braquial plexus block group
Arm Type
Active Comparator
Arm Description
Interscalenic braquial plexus block done at the moment of the surgery.
Intervention Type
Procedure
Intervention Name(s)
supraescapular nerve radiofrequency
Intervention Description
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
Intervention Type
Procedure
Intervention Name(s)
interescalenic braquial plexus
Intervention Description
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
Primary Outcome Measure Information:
Title
Visual analogical scale
Description
Postoperative acute pain measurement. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
Time Frame
periodical measurements of pain, inmediate preoperative pain up to three months postoperative
Secondary Outcome Measure Information:
Title
Visual analogical scale
Description
chronic pain after surgery. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
Time Frame
3 months postop. until 1 year postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Over 18 y.o.
Cronic pain (more than 3 months) due to rotator cuff arthropathy
VAS higher than 4
Decrease Constant score
Conservative treatment (physiotherapy and NSAIs) unsuccessful
Exclusion criteria:
psychiatric illness
drug abuse.
previous surgeries.
acute traumatic pathology or ethiology different from rotator cuff arthropathy
pacemaker
infectious process
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Carmen González López
Phone
0034 675175531
Email
mcglez89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus Manuel García Hernández
Phone
0034 690739292
Email
jesusgciahdez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Lopez Millan
Organizational Affiliation
Hospital Universitario Virgen Macarena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Carmen Gonzalez Lopez
Phone
0034 675175531
Email
mcglez89@gmail.com
First Name & Middle Initial & Last Name & Degree
Jesus Garcia Hernandez
Phone
0034 690739292
Email
jesusgciahdez@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty
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