Rotator Cuff SyndromePhase 2NCT02495818
Suprascapular Nerve Block Guided by Ultrasound
A Phase 2 study testing Lidocaine, Saline solution and Homemade exercises in people with Rotator Cuff Syndrome, run by Marta Imamura at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Lidocaine, Saline solution and Homemade exercises
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- History of:
- Shoulder surgery;
- Athletic activities;
- Severe shoulder arthrosis;
- Diagnosis of total rupture of supraspinatus tendon
- Autoimmune disease;
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, 05716-150
About this study
Official title: Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial
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.
Read the 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.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Lidocaine, Saline solution, Homemade exercises
- Keywords
- Rotator cuff syndrome, supraspinatus tendonitis, suprascapular nerve block, ultrasound guided, supraspinatus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineProcedure or surgery
Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.
Saline solutionProcedure or surgery
Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution
Homemade exercisesOther
Codman and Hughston exercises.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises). Receives: Procedure: Lidocaine; Other: Homemade exercises |
| Saline solution | Sham comparator | Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises). Receives: Procedure: Saline solution; Other: Homemade exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and one week after intervention
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and twelve weeks 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
Measured: 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
Measured: Baseline and twelve weeks after intervention
Safety as assessed by the number of Adverse Events
Assessment of possible Adverse Events after the intervention
Measured: 1 week and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Imamura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, MD, Principal investigator, Instituto de Medicina Física e Reabilitação HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495818
- Sponsor's protocol ID
- Suprascapular Nerve Block
- Status last verified
- May 2018
- First submitted
- 1 Jul 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Otani PT, Rached RDVA, Alfieri FM, de Azevedo Neto RS, Hsing WT, Battistella LR, Imamura M. Ultrasound-guided suprascapular nerve block with lidocaine vs. saline combined with physical exercises for the rehabilitation of supraspinatus tendinitis: a randomized double-blind controlled trial. Front Pain Res (Lausanne). 2024 Nov 12;5:1490320. doi: 10.3389/fpain.2024.1490320. eCollection 2024.
PubMed 39600565
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02495818
- Acronym / sponsor ID
- Suprascapular Nerve Block
- Conditions
- Rotator Cuff Syndrome
- Keywords
- Rotator cuff syndrome, supraspinatus tendonitis, suprascapular nerve block, ultrasound guided, supraspinatus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Marta ImamuraUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Procedure: Lidocaine, Other: Homemade exercisesSuprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises). |
| Saline solution | Sham comparator | Procedure: Saline solution, Other: Homemade exercisesIntervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (22 listed)
- History of:
- Pregnancy;
- Use of oral or subcutaneous anticoagulation agent;
- Patients who fail to comply with the proposed treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineSuprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%. | Procedure or surgery | Lidocaine |
| Saline solutionSuprascapular Nerve Block Guided by Ultrasound with 5ml saline solution | Procedure or surgery | Saline solution |
| Homemade exercisesCodman and Hughston exercises. | Other | Lidocaine, Saline solution |
Primary outcome
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.
8 secondary outcomes
Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).
Time frame: Baseline and one week after intervention.
Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).
Time frame: Baseline and twelve weeks after intervention.
Change from baseline in the score of pain and function as assessed by SPADI
Time frame: Baseline and 12 weeks after intervention
Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry
Time frame: Baseline and one week after intervention
Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry
Time frame: Baseline and twelve weeks after intervention
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Time frame: Baseline and one week after intervention
Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry
Time frame: Baseline and twelve weeks after intervention
Safety as assessed by the number of Adverse Events
Time frame: 1 week and 12 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 39600565Otani PT, Rached RDVA, Alfieri FM, de Azevedo Neto RS, Hsing WT, Battistella LR, Imamura M. Ultrasound-guided suprascapular nerve block with lidocaine vs. saline combined with physical exercises for the rehabilitation of supraspinatus tendinitis: a randomized double-blind controlled trial. Front Pain Res (Lausanne). 2024 Nov 12;5:1490320. doi: 10.3389/fpain.2024.1490320. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Imamura, MD principal investigator
Instituto de Medicina Física e Reabilitação HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine, Saline solution and Homemade exercises in people with Rotator Cuff Syndrome, run by Marta Imamura at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.