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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.
Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution
Codman and Hughston exercises.
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, Brazil
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.
Time frame: Baseline and one week after intervention
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)
Time frame: Baseline and one week after intervention.
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)
Time frame: Baseline and twelve weeks after intervention.
Change from baseline in the score of pain and function as assessed by SPADI
Scale for assessing pain and shoulder function.
Time frame: Baseline and 12 weeks after intervention
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.
Time frame: Baseline and one week after intervention
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.
Time frame: Baseline and twelve weeks after intervention
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
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Goniometry for active movements for flexion and abduction of the shoulder
Time frame: Baseline and one week after intervention
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Goniometry for active movements for flexion and abduction of the shoulder
Time frame: Baseline and twelve weeks after intervention
Safety as assessed by the number of Adverse Events
Assessment of possible Adverse Events after the intervention
Time frame: 1 week and 12 weeks after intervention