Trial Outcomes & Findings for Comparison of the Efficacy of Two Different Suprascapular Nerve Block Techniques in Patients With Chronic Shoulder Pain (NCT NCT04938037)
NCT ID: NCT04938037
Last Updated: 2025-05-20
Results Overview
Shoulder pain and disability index (SPADI). The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Each item is scored between 0 and 10, and the resulting score is converted into a 100-point scale separately for pain, disability, and total score. Increased SPADI scores indicate an increase in patients' shoulder-related pain and disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline and 1, 4, and 12 weeks after injection
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
SSNB Through the Spinoglenoid Notch
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
SSNB Through the Spinoglenoid Notch
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Comparison of the Efficacy of Two Different Suprascapular Nerve Block Techniques in Patients With Chronic Shoulder Pain
Baseline characteristics by cohort
| Measure |
SSNB Through the Spinoglenoid Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI, kg/m2
|
29.2 Kg/m2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
30 Kg/m2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
29.6 Kg/m2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Affected shoulder, right
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Symptom duration, months
|
14.2 months
STANDARD_DEVIATION 9.5 • n=5 Participants
|
15.6 months
STANDARD_DEVIATION 12.3 • n=7 Participants
|
14.9 months
STANDARD_DEVIATION 11 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1, 4, and 12 weeks after injectionShoulder pain and disability index (SPADI). The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Each item is scored between 0 and 10, and the resulting score is converted into a 100-point scale separately for pain, disability, and total score. Increased SPADI scores indicate an increase in patients' shoulder-related pain and disability.
Outcome measures
| Measure |
SSNB Through the Spinoglenoid Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI- Total (Baseline- 1st week)
|
22.1 score on a scale
Standard Deviation 20.3
|
25.9 score on a scale
Standard Deviation 23.7
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI- Total (Baseline- 4th week)
|
27.0 score on a scale
Standard Deviation 22.2
|
36.6 score on a scale
Standard Deviation 22.0
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI- Total (Baseline- 12th week)
|
29.4 score on a scale
Standard Deviation 23.0
|
34.1 score on a scale
Standard Deviation 28.1
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI - Pain (Baseline - 1st week)
|
25.9 score on a scale
Standard Deviation 22.2
|
27.5 score on a scale
Standard Deviation 24.4
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI - Pain (Baseline - 4th week)
|
29.4 score on a scale
Standard Deviation 24.1
|
37.6 score on a scale
Standard Deviation 21.7
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI - Pain (Baseline - 12th week)
|
30.3 score on a scale
Standard Deviation 26.0
|
35.7 score on a scale
Standard Deviation 28.6
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI - Disability (Baseline - 1st week)
|
20.3 score on a scale
Standard Deviation 20.3
|
24.8 score on a scale
Standard Deviation 24.5
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI - Disability (Baseline - 4th week)
|
26.0 score on a scale
Standard Deviation 22.3
|
35.8 score on a scale
Standard Deviation 23.8
|
|
Change of Shoulder Pain and Disability Index (SPADI)
SPADI - Disability (Baseline - 12th week)
|
29.6 score on a scale
Standard Deviation 22.1
|
33.0 score on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: Baseline and 1, 4, and 12 weeks after injectionThe degree of shoulder pain for night and activity was assessed using Visual Analog Scale (VAS) (range 0-10) for each patient. VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain.
Outcome measures
| Measure |
SSNB Through the Spinoglenoid Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Change of Visual Analog Scale (VAS)
VAS Activity (Baseline - 1st week)
|
2.2 score on a scale
Standard Deviation 2.5
|
2.8 score on a scale
Standard Deviation 2.5
|
|
Change of Visual Analog Scale (VAS)
VAS Activity (Baseline - 4st week)
|
2.8 score on a scale
Standard Deviation 2.7
|
3.7 score on a scale
Standard Deviation 2.4
|
|
Change of Visual Analog Scale (VAS)
VAS Activity (Baseline - 12th week)
|
2.9 score on a scale
Standard Deviation 2.7
|
3.5 score on a scale
Standard Deviation 2.9
|
|
Change of Visual Analog Scale (VAS)
VAS Night (Baseline - 1st week)
|
3.2 score on a scale
Standard Deviation 2.6
|
3.0 score on a scale
Standard Deviation 2.9
|
|
Change of Visual Analog Scale (VAS)
VAS Night (Baseline - 4st week)
|
3.4 score on a scale
Standard Deviation 2.6
|
3.9 score on a scale
Standard Deviation 2.4
|
|
Change of Visual Analog Scale (VAS)
VAS Night (Baseline - 12th week)
|
3.1 score on a scale
Standard Deviation 2.7
|
3.3 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline and 1, 4, and 12 weeks after injectionActive ROM of the affected shoulder is measured using a goniometer. These measurements included abduction, flexion, internal rotation, and external rotation.
Outcome measures
| Measure |
SSNB Through the Spinoglenoid Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Change of Range of Motion (ROM)
ROM flexion (Baseline- 1st week)
|
-3.9 degree
Standard Deviation 16.0
|
-9.6 degree
Standard Deviation 14.0
|
|
Change of Range of Motion (ROM)
ROM flexion (Baseline- 4th week)
|
-8.6 degree
Standard Deviation 18.3
|
-18.6 degree
Standard Deviation 21.2
|
|
Change of Range of Motion (ROM)
ROM flexion (Baseline- 12th week)
|
-8.8 degree
Standard Deviation 18.1
|
-20.5 degree
Standard Deviation 22.2
|
|
Change of Range of Motion (ROM)
ROM abduction (Baseline- 1st week)
|
-4.8 degree
Standard Deviation 14.4
|
-9.6 degree
Standard Deviation 16.1
|
|
Change of Range of Motion (ROM)
ROM abduction (Baseline- 4th week)
|
-14.1 degree
Standard Deviation 24.9
|
-23.9 degree
Standard Deviation 30.1
|
|
Change of Range of Motion (ROM)
ROM abduction (Baseline- 12th week)
|
-13.0 degree
Standard Deviation 27.7
|
-26.0 degree
Standard Deviation 29.1
|
|
Change of Range of Motion (ROM)
ROM internal rotation (Baseline- 1st week)
|
0.9 degree
Standard Deviation 4.7
|
-4.5 degree
Standard Deviation 9.7
|
|
Change of Range of Motion (ROM)
ROM internal rotation (Baseline- 4th week)
|
-0.9 degree
Standard Deviation 3.2
|
-7.5 degree
Standard Deviation 11.9
|
|
Change of Range of Motion (ROM)
ROM internal rotation (Baseline- 12th week)
|
-2.4 degree
Standard Deviation 7.0
|
-8.6 degree
Standard Deviation 12.2
|
|
Change of Range of Motion (ROM)
ROM external rotation (Baseline- 1st week)
|
-2.5 degree
Standard Deviation 6.9
|
-6.8 degree
Standard Deviation 17.3
|
|
Change of Range of Motion (ROM)
ROM external rotation (Baseline- 4th week)
|
-6.0 degree
Standard Deviation 8.9
|
-10.9 degree
Standard Deviation 16.0
|
|
Change of Range of Motion (ROM)
ROM external rotation (Baseline- 12th week)
|
-8.5 degree
Standard Deviation 12.3
|
-10.0 degree
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Baseline and 1, 4, and 12 weeks after injectionIn order to determine the pain perception thresholds in the affected shoulder, Pain Pressure Threshold (PPT) values will be calculated by taking three measurements from the middle deltoid, upper trapezius, infraspinatus and tibialis anterior area with an algometer (Commander Echo® Algometer, JTECH Medical, Midvale, UT, USA). The average of the last 2 measurements will be taken and recorded. The PPT values were expressed as kilograms per square centimeter (kg/cm2). A low PPT value represents a decrease in the pain threshold and, therefore, increased sensitivity.
Outcome measures
| Measure |
SSNB Through the Spinoglenoid Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Change of Pain Pressure Threshold (PPT)
PPT - upper trapezius (Baseline-1st week)
|
-0.3 kg/cm2
Standard Deviation 1.5
|
0.0 kg/cm2
Standard Deviation 1.5
|
|
Change of Pain Pressure Threshold (PPT)
PPT - upper trapezius (Baseline-4th week)
|
-0.1 kg/cm2
Standard Deviation 1.2
|
-0.4 kg/cm2
Standard Deviation 1.4
|
|
Change of Pain Pressure Threshold (PPT)
PPT - upper trapezius (Baseline-12th week)
|
-0.2 kg/cm2
Standard Deviation 1.4
|
-0.3 kg/cm2
Standard Deviation 1.3
|
|
Change of Pain Pressure Threshold (PPT)
PPT - middle deltoid (Baseline-1st week)
|
-0.2 kg/cm2
Standard Deviation 1.0
|
0.3 kg/cm2
Standard Deviation 1.5
|
|
Change of Pain Pressure Threshold (PPT)
PPT - middle deltoid (Baseline-4th week)
|
0.0 kg/cm2
Standard Deviation 1.5
|
0.1 kg/cm2
Standard Deviation 1.8
|
|
Change of Pain Pressure Threshold (PPT)
PPT - middle deltoid (Baseline-12th week)
|
-0.2 kg/cm2
Standard Deviation 1.6
|
-0.2 kg/cm2
Standard Deviation 1.6
|
|
Change of Pain Pressure Threshold (PPT)
PPT - Infraspinatus (Baseline-1st week)
|
-0.3 kg/cm2
Standard Deviation 1.4
|
-0.1 kg/cm2
Standard Deviation 1.6
|
|
Change of Pain Pressure Threshold (PPT)
PPT - Infraspinatus (Baseline-4th week)
|
0.0 kg/cm2
Standard Deviation 1.9
|
-0.2 kg/cm2
Standard Deviation 1.6
|
|
Change of Pain Pressure Threshold (PPT)
PPT - Infraspinatus (Baseline-12th week)
|
-0.4 kg/cm2
Standard Deviation 1.7
|
-0.2 kg/cm2
Standard Deviation 1.7
|
|
Change of Pain Pressure Threshold (PPT)
PPT - Tibialis Anterior (Baseline-1st week)
|
-0.3 kg/cm2
Standard Deviation 2.3
|
-0.2 kg/cm2
Standard Deviation 1.4
|
|
Change of Pain Pressure Threshold (PPT)
PPT - Tibialis Anterior (Baseline-4th week)
|
-0.1 kg/cm2
Standard Deviation 1.9
|
0.1 kg/cm2
Standard Deviation 1.8
|
|
Change of Pain Pressure Threshold (PPT)
PPT - Tibialis Anterior (Baseline-12th week)
|
-0.4 kg/cm2
Standard Deviation 1.7
|
-0.4 kg/cm2
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Assessed at baseline and 1, 4, and 12 weeks after injection, with week 12 reported.Patient satisfaction with the injection is determined by Likert Scale (1= very dissatisfied, 2= dissatisfied, 3=neither dissatisfied or satisfied, 4= satisfied, 5= very satisfied)
Outcome measures
| Measure |
SSNB Through the Spinoglenoid Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Suprascapular Notch
n=40 Participants
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
Patient Satisfaction
neither dissatisfied or satisfied
|
3 Participants
|
6 Participants
|
|
Patient Satisfaction
Extremely dissatisfied
|
3 Participants
|
2 Participants
|
|
Patient Satisfaction
Dissatisfied
|
8 Participants
|
1 Participants
|
|
Patient Satisfaction
Satisfied
|
12 Participants
|
11 Participants
|
|
Patient Satisfaction
Extremely satisfied
|
14 Participants
|
20 Participants
|
Adverse Events
SSNB Through the Suprascapular Notch
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SSNB Through the Spinoglenoid Notch
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SSNB Through the Suprascapular Notch
n=40 participants at risk
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
SSNB Through the Spinoglenoid Notch
n=40 participants at risk
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine: nerve block
|
|---|---|---|
|
General disorders
motor block
|
2.5%
1/40 • Number of events 1 • Adverse events up to the 12th week post-injection control were recorded.
|
5.0%
2/40 • Number of events 2 • Adverse events up to the 12th week post-injection control were recorded.
|
|
General disorders
presyncope
|
2.5%
1/40 • Number of events 1 • Adverse events up to the 12th week post-injection control were recorded.
|
2.5%
1/40 • Number of events 1 • Adverse events up to the 12th week post-injection control were recorded.
|
|
Injury, poisoning and procedural complications
redness and swelling at the injection site
|
0.00%
0/40 • Adverse events up to the 12th week post-injection control were recorded.
|
2.5%
1/40 • Number of events 1 • Adverse events up to the 12th week post-injection control were recorded.
|
|
General disorders
headache
|
5.0%
2/40 • Number of events 2 • Adverse events up to the 12th week post-injection control were recorded.
|
0.00%
0/40 • Adverse events up to the 12th week post-injection control were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place