Suprascapular Nerve Block Guided by Ultrasound

NCT ID: NCT02495818

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

Rotator Cuff Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: PROCEDURE

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

Homemade exercises

Intervention Type: OTHER

Codman and Hughston exercises.

Saline solution

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

Group Type: SHAM_COMPARATOR

Saline solution

Intervention Type: PROCEDURE

Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution

Homemade exercises

Intervention Type: OTHER

Codman and Hughston exercises.

Interventions

Lidocaine

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

Intervention Type: PROCEDURE

Saline solution

Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution

Intervention Type: PROCEDURE

Homemade exercises

Codman and Hughston exercises.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marta Imamura

OTHER

Sponsor Role: lead

Responsible Party

Marta Imamura

Coordinator of the Clinical Research Center for Physical and Rehabilitation Medicine of HC FMUSP

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Imamura, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Física e Reabilitação HCFMUSP

Locations

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39600565 (View on PubMed)

Other Identifiers

Suprascapular Nerve Block

Identifier Type: -

Identifier Source: org_study_id