Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis

January 5, 2019 updated by: Luis Alonso Calderon Cordova, Instituto Mexicano del Seguro Social

Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis

Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Mexico
    • Gustavo A Madero
      • Mexico City, Gustavo A Madero, Mexico, 07760
        • Department of Orthopedics, UMAE "Dr. Victorio de la Fuente Narváez" IMSS-UNAM. Ciudad de México, México

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IMSS affiliated
  • Glenohumeral arthritis diagnosed

Exclusion Criteria:

  • Previusly treatment for the same disease
  • No follow up
  • Dead

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Shoulder infiltration
Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg
Drug: Methylprednisolone Acetate
depo-medrol 40 mg
Other Names:
  • depo-medrol 40 mg
Drug: Lidocaine 2% Injectable Solution
2ml of 2% lidocaine
Other Names:
  • xilocaine
Experimental: Suprascapular nerve block
Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg
Drug: Methylprednisolone Acetate
depo-medrol 40 mg
Other Names:
  • depo-medrol 40 mg
Drug: Ropivacaine HCl Inj 7.5 MG/ML
25 mg
Other Names:
  • Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain before
Time Frame: VAS before intervention
visual analogue scale
VAS before intervention
Pain 2 months after
Time Frame: VAS 2 months after
Visual analogue scale 2 months after procedure
VAS 2 months after
Pain 6 months after
Time Frame: VAS 6 months after
Visual analogue scale 6 months after procedure
VAS 6 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life before procedure
Time Frame: SF12v2 before procedure
SF12v2 Health related quality of life before procedure
SF12v2 before procedure
Quality of life 2 months after procedure
Time Frame: SF12v2 2 months after
SF12v2 Health related quality of life 2 months after
SF12v2 2 months after
Quality of life 6 months after procedure
Time Frame: SF12v2 6 months after
SF12v2 Health related quality of life 6 months after
SF12v2 6 months after

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Luis Alonso Calderon Cordova, MD, IMSS

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)

April 1, 2018

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 5, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2018-3401-056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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