NCT03794505

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 3, 2019

Last Update Submit

January 5, 2019

Conditions

Shoulder Arthritis

Outcome Measures

Primary Outcomes (3)

  • Pain before

    visual analogue scale

    VAS before intervention

  • Pain 2 months after

    Visual analogue scale 2 months after procedure

    VAS 2 months after

  • Pain 6 months after

    Visual analogue scale 6 months after procedure

    VAS 6 months after

Secondary Outcomes (3)

  • Quality of life before procedure

    SF12v2 before procedure

  • Quality of life 2 months after procedure

    SF12v2 2 months after

  • Quality of life 6 months after procedure

    SF12v2 6 months after

Study Arms (2)

Shoulder infiltration

ACTIVE COMPARATOR

Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg

Drug: Methylprednisolone AcetateDrug: Lidocaine 2% Injectable Solution

Suprascapular nerve block

EXPERIMENTAL

Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg

Drug: Methylprednisolone AcetateDrug: Ropivacaine HCl Inj 7.5 MG/ML

Interventions

Methylprednisolone AcetateDRUG

depo-medrol 40 mg

Also known as: depo-medrol 40 mg
Shoulder infiltrationSuprascapular nerve block
Lidocaine 2% Injectable SolutionDRUG

2ml of 2% lidocaine

Also known as: xilocaine
Shoulder infiltration
Ropivacaine HCl Inj 7.5 MG/MLDRUG

25 mg

Also known as: Ropivacaine
Suprascapular nerve block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IMSS affiliated
  • Glenohumeral arthritis diagnosed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics, UMAE "Dr. Victorio de la Fuente Narváez" IMSS-UNAM. Ciudad de México, México

Mexico City, Gustavo A Madero, 07760, Mexico

Location

MeSH Terms

Interventions

Methylprednisolone AcetateLidocaineRopivacaine

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Luis Alonso Calderon Cordova, MD

    IMSS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

April 1, 2018

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)