Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Procedure | Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and one week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and one week after intervention. |
| Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of:
Pregnancy;
Use of oral or subcutaneous anticoagulation agent;
Patients who fail to comply with the proposed treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marta Imamura, MD | Instituto de Medicina FÃsica e Reabilitação HCFMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Fisica e Reabilitacao HCFMUSP | São Paulo | 05716-150 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39600565 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline solution |
| Procedure |
Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution |
|
| Homemade exercises | Other | Codman and Hughston exercises. |
|
Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain) |
| 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. | 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. | 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. | 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 | 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 | Baseline and twelve weeks after intervention |
| Safety as assessed by the number of Adverse Events | Assessment of possible Adverse Events after the intervention | 1 week and 12 weeks after intervention |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |