Suprascapular Nerve Block Guided by Ultrasound

Rotator Cuff Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495818
• Other study ID #: Suprascapular Nerve Block
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Syndrome

Intervention

Procedure:
• Lidocaine
Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.
• Saline solution
Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution

Other:
• Homemade exercises
Codman and Hughston exercises.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Fisica e Reabilitacao HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Marta Imamura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety as assessed by the number of Adverse Events	Assessment of possible Adverse Events after the intervention	1 week and 12 weeks after intervention