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

Phase 3

Completed

• Conditions: Shoulder Arthritis
• Interventions: Drug: Methylprednisolone Acetate; Drug: Lidocaine 2% Injectable Solution; Drug: Ropivacaine HCl Inj 7.5 MG/ML

• Registration Number: NCT03794505
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

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

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 Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-05
• Study First Posted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• IMSS affiliated
• Glenohumeral arthritis diagnosed

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shoulder infiltration	Methylprednisolone Acetate	Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg
Suprascapular nerve block	Methylprednisolone Acetate	Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg
Shoulder infiltration	Lidocaine 2% Injectable Solution	Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg
Suprascapular nerve block	Ropivacaine HCl Inj 7.5 MG/ML	Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg

Primary Outcome Measures

Name	Time	Method
Pain before	VAS before intervention	visual analogue scale
Pain 2 months after	VAS 2 months after	Visual analogue scale 2 months after procedure
Pain 6 months after	VAS 6 months after	Visual analogue scale 6 months after procedure

Secondary Outcome Measures

Name	Time	Method
Quality of life before procedure	SF12v2 before procedure	SF12v2 Health related quality of life before procedure
Quality of life 2 months after procedure	SF12v2 2 months after	SF12v2 Health related quality of life 2 months after
Quality of life 6 months after procedure	SF12v2 6 months after	SF12v2 Health related quality of life 6 months after

Trial Locations

Locations (1)

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