Suprascapular Nerve Block Guided by Ultrasound

Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Syndrome
• Intervention / Treatment: Procedure: Lidocaine; Other: Homemade exercises; Procedure: Saline solution

Detailed Description

The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since June 2013. The investigators are including patients with clinical diagnosis of supraspinatus tendinitis based on the Lateral Jobe Test.

The patients are being randomized in two arms: Active (2% 5ml lidocaine for suprascapular nerve block and home exercises) and placebo control (saline solution as the nerve block and home exercises). The randomization is being performed in blocks of 4 and 6.

The investigator, the raters, the MD who makes the procedure and the patients are blind to treatment.

4 visits are being performed. Screening and initial evaluation visit, procedure visit, follow up 1 week after intervention and follow up 12 weeks after intervention.

The sample size was estimated to be 54 in each arm.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05716-150
    • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• History of:

  1. Shoulder surgery;
  2. Athletic activities;
  3. Severe shoulder arthrosis;
  4. Diagnosis of total rupture of supraspinatus tendon
  5. Autoimmune disease;
  6. Fracture of humerus, acromion and clavicle
  7. Luxation and subluxation of shoulder.
  8. Diseases that cause spasticity, such as stroke or spinal cord injury;
  9. Systemic alterations that can lead to peripheral neuropathy;
  10. Uncontrolled Diabetes or thyroidopathy;
  11. Diagnosis of cervical spinal cord injury that results in motor alterations;
  12. Allergy or hypersensibility for local or systemic anaesthetics;
  13. Coagulopathy;
  14. Fibromyalgia according to the 1990 American School of Rheumatology;
  15. Uncontrolled psychiatric diseases or controlled psychiatric diseases that need more than two medicines;
  16. Acute of chronic renal failure;
  17. Pulmonary diseases that presents hypoxemia such as Gold IV Chronic Obstructive Pulmonary Disease or pulmonary fibrosis.
  18. Arrhythmia (except isolated supraventricular extrasystoles), coronary failure or functional class 2 or higher heart failure
• Pregnancy;
• Use of oral or subcutaneous anticoagulation agent;
• Patients who fail to comply with the proposed treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).	Procedure: Lidocaine; Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.; Other: Homemade exercises; Codman and Hughston exercises.
Sham Comparator: Saline solution; Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).	Other: Homemade exercises; Codman and Hughston exercises.; Procedure: Saline solution; Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).	Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)	Baseline and one week after intervention.
Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).	Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)	Baseline and twelve weeks after intervention.
Change from baseline in the score of pain and function as assessed by SPADI	Scale for assessing pain and shoulder function.	Baseline and 12 weeks after intervention
Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry	Measurement of pain under pressure of the structures of dermatome, myotome and sclerotome corresponding to levels C5 and C6 of spinal cord.	Baseline and one week after intervention
Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry	Measurement of pain under pressure of the structures of dermatome, myotome and sclerotome corresponding to levels C5 and C6 of spinal cord.	Baseline and twelve weeks after intervention
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry	Goniometry for active movements for flexion and abduction of the shoulder	Baseline and one week after intervention
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry	Goniometry for active movements for flexion and abduction of the shoulder	Baseline and twelve weeks after intervention
Safety as assessed by the number of Adverse Events	Assessment of possible Adverse Events after the intervention	1 week and 12 weeks after intervention

Collaborators and Investigators

• Sponsor: Marta Imamura

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: ultrasound guided; suprascapular nerve block; Rotator cuff syndrome; supraspinatus tendonitis; supraspinatus
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Suprascapular Nerve Block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No