Suprascapular Nerve Block Guided by Ultrasound

Phase 2

Completed

• Conditions: Rotator Cuff Syndrome
• Interventions: Procedure: Saline solution; Procedure: Lidocaine; Other: Homemade exercises

• Registration Number: NCT02495818
• Lead Sponsor: Marta Imamura

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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-13
• Primary Completion: 2017-03
• Study Completion: 2017-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Homemade exercises	Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Saline solution	Saline solution	Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Lidocaine	Lidocaine	Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Saline solution	Homemade exercises	Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).

Primary Outcome Measures

Name	Time	Method
Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)	Baseline and one week after intervention	Scale for assessing pain and shoulder function.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP; 🇧🇷 Sao Paulo, Brazil