Suprascapular Nerve Block Guided by Ultrasound

NCT02495818 | Completed Phase 2 DMC

• 1 other identifier: Suprascapular Nerve Block
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of suprascapular nerve block guided by ultrasound combined with home exercises compared with placebo. Pain intensity, function, pressure pain threshold and goniometry were designed to be assessed in all patients.

Conditions

Rotator Cuff Syndrome

Keywords

Rotator cuff syndrome; supraspinatus tendonitis; suprascapular nerve block; ultrasound guided; supraspinatus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)

  Scale for assessing pain and shoulder function.

  Baseline and one week after intervention

Secondary Outcomes (8)

• Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).

  Baseline and one week after intervention.

• Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).

  Baseline and twelve weeks after intervention.

• Change from baseline in the score of pain and function as assessed by SPADI

  Baseline and 12 weeks after intervention

• Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry

  Baseline and one week after intervention

• Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry

  Baseline and twelve weeks after intervention

Study Arms (2)

Lidocaine

EXPERIMENTAL

Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).

Procedure: Lidocaine; Other: Homemade exercises

Saline solution

SHAM COMPARATOR

Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).

Procedure: Saline solution; Other: Homemade exercises

Interventions

Lidocaine PROCEDURE

Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.

Lidocaine

Saline solution PROCEDURE

Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution

Saline solution

Homemade exercises OTHER

Codman and Hughston exercises.

Lidocaine; Saline solution

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of supraspinatus tendonitis, based on Jobe's lateral test;
• Pain longer than 1 month prior to screening visit;
• BMI between 20 and 30 kg/m²;
• VAS of 4 or higher in screening visit;
• Ability to understand the questionaires and instructions for home exercises;
• Signed Informed Consent Form;

You may not qualify if:

• History of:
• Shoulder surgery;
• Athletic activities;
• Severe shoulder arthrosis;
• Diagnosis of total rupture of supraspinatus tendon
• Autoimmune disease;
• Fracture of humerus, acromion and clavicle
• Luxation and subluxation of shoulder.
• Diseases that cause spasticity, such as stroke or spinal cord injury;
• Systemic alterations that can lead to peripheral neuropathy;
• Uncontrolled Diabetes or thyroidopathy;
• Diagnosis of cervical spinal cord injury that results in motor alterations;
• Allergy or hypersensibility for local or systemic anaesthetics;
• Coagulopathy;
• Fibromyalgia according to the 1990 American School of Rheumatology;

Sponsors & Collaborators

• Marta Imamura: lead

Study Sites (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 05716-150, Brazil

Location

Related Publications (1)

• Otani PT, Rached RDVA, Alfieri FM, de Azevedo Neto RS, Hsing WT, Battistella LR, Imamura M. Ultrasound-guided suprascapular nerve block with lidocaine vs. saline combined with physical exercises for the rehabilitation of supraspinatus tendinitis: a randomized double-blind controlled trial. Front Pain Res (Lausanne). 2024 Nov 12;5:1490320. doi: 10.3389/fpain.2024.1490320. eCollection 2024.

  PMID: 39600565 DERIVED

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marta Imamura, MD

  Instituto de Medicina Física e Reabilitação HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator of the Clinical Research Center for Physical and Rehabilitation Medicine of HC FMUSP

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 13, 2015
• Study Start: June 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)