Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rotator Cuff Syndrome
- Sponsor
- Marta Imamura
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Marta Imamura
Coordinator of the Clinical Research Center for Physical and Rehabilitation Medicine of HC FMUSP
University of Sao Paulo
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:
- •Shoulder surgery;
- •Athletic activities;
- •Severe shoulder arthrosis;
- •Diagnosis of total rupture of supraspinatus tendon
- •Autoimmune disease;
- •Fracture of humerus, acromion and clavicle
- •Luxation and subluxation of shoulder.
- •Diseases that cause spasticity, such as stroke or spinal cord injury;
- •Systemic alterations that can lead to peripheral neuropathy;
Outcomes
Primary Outcomes
Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline and one week after intervention
Scale for assessing pain and shoulder function.
Secondary Outcomes
- Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).(Baseline and twelve weeks after intervention.)
- Change from baseline in the score of pain and function as assessed by SPADI(Baseline and 12 weeks after intervention)
- Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry(Baseline and twelve weeks after intervention)
- Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry(Baseline and twelve weeks after intervention)
- Safety as assessed by the number of Adverse Events(1 week and 12 weeks after intervention)