Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty

NCT ID: NCT05785572

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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

Conditions

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Rotator Cuff Tear Arthropathy Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial with two groups of study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Double blind trial

Study Groups

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Radiofrequency group

Patient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery

Group Type EXPERIMENTAL

supraescapular nerve radiofrequency

Intervention Type PROCEDURE

supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery

Interscalenic braquial plexus block group

Interscalenic braquial plexus block done at the moment of the surgery.

Group Type ACTIVE_COMPARATOR

interescalenic braquial plexus

Intervention Type PROCEDURE

supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery

Interventions

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supraescapular nerve radiofrequency

supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery

Intervention Type PROCEDURE

interescalenic braquial plexus

supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen Macarena

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Manuel Lopez Millan

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

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Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Carmen González López

Role: CONTACT

0034 675175531

Jesus Manuel García Hernández

Role: CONTACT

0034 690739292

Facility Contacts

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Maria Carmen Gonzalez Lopez

Role: primary

0034 675175531

Jesus Garcia Hernandez

Role: backup

0034 690739292

Other Identifiers

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DAP_PIH_20

Identifier Type: -

Identifier Source: org_study_id

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