Back to resultsSuprascapular Nerve Block Guided by Ultrasound
Primary Purpose
Rotator Cuff Syndrome
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Saline solution
Homemade exercises
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Syndrome focused on measuring Rotator cuff syndrome, supraspinatus tendonitis, suprascapular nerve block, ultrasound guided, supraspinatus
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;
- Uncontrolled Diabetes or thyroidopathy;
- Diagnosis of cervical spinal cord injury that results in motor alterations;
- Allergy or hypersensibility for local or systemic anaesthetics;
- Coagulopathy;
- Fibromyalgia according to the 1990 American School of Rheumatology;
- Uncontrolled psychiatric diseases or controlled psychiatric diseases that need more than two medicines;
- Acute of chronic renal failure;
- Pulmonary diseases that presents hypoxemia such as Gold IV Chronic Obstructive Pulmonary Disease or pulmonary fibrosis.
- 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.
Sites / Locations
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Lidocaine
Saline solution
Arm Description
Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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)
Change from baseline in the score of pain and function as assessed by SPADI
Scale for assessing pain and shoulder function.
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.
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.
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Goniometry for active movements for flexion and abduction of the shoulder
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Goniometry for active movements for flexion and abduction of the shoulder
Safety as assessed by the number of Adverse Events
Assessment of possible Adverse Events after the intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02495818
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marta Imamura
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Syndrome
Keywords
Rotator cuff syndrome, supraspinatus tendonitis, suprascapular nerve block, ultrasound guided, supraspinatus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Arm Title
Saline solution
Arm Type
Sham Comparator
Arm Description
Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
Intervention Type
Procedure
Intervention Name(s)
Lidocaine
Intervention Description
Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.
Intervention Type
Procedure
Intervention Name(s)
Saline solution
Intervention Description
Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution
Intervention Type
Other
Intervention Name(s)
Homemade exercises
Intervention Description
Codman and Hughston exercises.
Primary Outcome Measure Information:
Title
Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)
Description
Scale for assessing pain and shoulder function.
Time Frame
Baseline and one week after intervention
Secondary Outcome Measure Information:
Title
Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).
Description
Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)
Time Frame
Baseline and one week after intervention.
Title
Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).
Description
Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)
Time Frame
Baseline and twelve weeks after intervention.
Title
Change from baseline in the score of pain and function as assessed by SPADI
Description
Scale for assessing pain and shoulder function.
Time Frame
Baseline and 12 weeks after intervention
Title
Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry
Description
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
Title
Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry
Description
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
Title
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Description
Goniometry for active movements for flexion and abduction of the shoulder
Time Frame
Baseline and one week after intervention
Title
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Description
Goniometry for active movements for flexion and abduction of the shoulder
Time Frame
Baseline and twelve weeks after intervention
Title
Safety as assessed by the number of Adverse Events
Description
Assessment of possible Adverse Events after the intervention
Time Frame
1 week and 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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;
Uncontrolled Diabetes or thyroidopathy;
Diagnosis of cervical spinal cord injury that results in motor alterations;
Allergy or hypersensibility for local or systemic anaesthetics;
Coagulopathy;
Fibromyalgia according to the 1990 American School of Rheumatology;
Uncontrolled psychiatric diseases or controlled psychiatric diseases that need more than two medicines;
Acute of chronic renal failure;
Pulmonary diseases that presents hypoxemia such as Gold IV Chronic Obstructive Pulmonary Disease or pulmonary fibrosis.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Imamura, MD
Organizational Affiliation
Instituto de Medicina Física e Reabilitação HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
City
Sao Paulo
ZIP/Postal Code
05716-150
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Suprascapular Nerve Block Guided by Ultrasound
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