Clinical trial NCT02495818: Suprascapular Nerve Block Guided by Ultrasound
Official title: Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rotator Cuff Syndrome
Keywords: Rotator cuff syndrome
supraspinatus tendonitis
suprascapular nerve block
ultrasound guided
supraspinatus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline and one week after intervention
Secondary outcomes:
measure: Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).
timeFrame: Baseline and one week after intervention.
measure: Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).
timeFrame: Baseline and twelve weeks after intervention.
measure: Change from baseline in the score of pain and function as assessed by SPADI
timeFrame: Baseline and 12 weeks after intervention
measure: Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry
timeFrame: Baseline and one week after intervention
measure: Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry
timeFrame: Baseline and twelve weeks after intervention
measure: Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
timeFrame: Baseline and one week after intervention
measure: Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
timeFrame: Baseline and twelve weeks after intervention
measure: Safety as assessed by the number of Adverse Events
timeFrame: 1 week and 12 weeks after intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Study officials:
affiliation: Instituto de Medicina Física e Reabilitação HCFMUSP
name: Marta Imamura, MD
role: PRINCIPAL_INVESTIGATOR
References: