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

Sponsor
Instituto Mexicano del Seguro Social (Other)
Overall Status
Completed
CT.gov ID
NCT03794505
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Methylprednisolone Acetate
  • Drug: Lidocaine 2% Injectable Solution
  • Drug: Ropivacaine HCl Inj 7.5 MG/ML
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Aug 30, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain before [VAS before intervention]

      visual analogue scale

    2. Pain 2 months after [VAS 2 months after]

      Visual analogue scale 2 months after procedure

    3. Pain 6 months after [VAS 6 months after]

      Visual analogue scale 6 months after procedure

    Secondary Outcome Measures

    1. Quality of life before procedure [SF12v2 before procedure]

      SF12v2 Health related quality of life before procedure

    2. Quality of life 2 months after procedure [SF12v2 2 months after]

      SF12v2 Health related quality of life 2 months after

    3. Quality of life 6 months after procedure [SF12v2 6 months after]

      SF12v2 Health related quality of life 6 months after

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • IMSS affiliated

    • Glenohumeral arthritis diagnosed

    Exclusion Criteria:

    • Previusly treatment for the same disease

    • No follow up

    • Dead

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Orthopedics, UMAE "Dr. Victorio de la Fuente Narváez" IMSS-UNAM. Ciudad de México, México Mexico City Gustavo A Madero Mexico 07760

    Sponsors and Collaborators

    • Instituto Mexicano del Seguro Social

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luis Alonso Calderon Cordova, Principal Investigator, Instituto Mexicano del Seguro Social
    ClinicalTrials.gov Identifier:
    NCT03794505
    Other Study ID Numbers:
    • F-2018-3401-056
    First Posted:
    Jan 7, 2019
    Last Update Posted:
    Jan 8, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Methylprednisolone
    Methylprednisolone Acetate
    Methylprednisolone Hemisuccinate
    Prednisolone
    Prednisolone acetate
    Lidocaine
    Ropivacaine
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Jan 8, 2019