Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, 05716-150, Brazil
NCT Number: NCT02495818
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.
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Notify Me30 year–60 year
All sexes
Interventional
Phase 2
São Paulo, 05716-150, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and one week after intervention
Scale for assessing pain and shoulder function.
Time frame: Baseline and one week after intervention.
Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)
Time frame: Baseline and twelve weeks after intervention.
Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)
Time frame: Baseline and 12 weeks after intervention
Scale for assessing pain and shoulder function.
Time frame: Baseline and one week after intervention
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
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
Goniometry for active movements for flexion and abduction of the shoulder
Time frame: Baseline and twelve weeks after intervention
Goniometry for active movements for flexion and abduction of the shoulder
Time frame: 1 week and 12 weeks after intervention
Assessment of possible Adverse Events after the intervention
Marta Imamura
Other
Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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