Suprascapular Nerve Block Guided by Ultrasound

Marta Imamura

Status and phase: Completed; Phase 2

Conditions: Rotator Cuff Syndrome

Treatments: Procedure: Lidocaine; Procedure: Saline solution; Other: Homemade exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT02495818

Suprascapular Nerve Block

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups

Lidocaine

Experimental group

Description:

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

Treatment:

Procedure: Lidocaine

Other: Homemade exercises

Saline solution

Sham Comparator group

Description:

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

Treatment:

Procedure: Saline solution

Other: Homemade exercises