Comparison of the Efficacy of Two Different Suprascapular Nerve Block Techniques in Patients With Chronic Shoulder Pain

May 19, 2025 updated by: İsa Cüce, TC Erciyes University

Comparison of Efficacy and Safety of Two Different Ultrasound-Guided Suprascapular Nerve Block Techniques in Chronic Shoulder Pain: A Prospective Double-Blinded Randomized Controlled Study

The aim of this study is to compare the efficacy and safety of the suprascapular nerve block (SSNB) at the spinoglenoid notch with SSNB at the suprascapular notch, which is the most commonly used technique in patients with chronic shoulder pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic shoulder pain (>3 months) is one of the most common musculoskeletal problems leading to psychosocial problems. Its causes include subacromial impingement, tendinosis, calcific tendinitis, complete or partial tendon tears, adhesive capsulitis, subacromial bursitis, glenohumeral osteoarthritis, glenohumeral instability, and acromioclavicular joint pathologies. For the treatment of chronic shoulder pain, conservative or surgical methods can be applied. Suprascapular nerve block (SSNB) is an effective and safe treatment option for pain relief and increases in functional activity in these patients.

The suprascapular nerve (SSN) is a peripheral nerve has both motor and sensory fibers, originates from the ventral rami of C5-C6 nerve roots. SSN passes across the posterior triangle of the neck and through the suprascapular notch enters to the supraspinous fossa. Then it comes to the infraspinous fossa via the spinoglenoid notch. The SSN has 3 sensory branches: a medial subacromial branch passes to the suprascapular notch, a lateral subacromial branch and a posterior glenohumeral branch pass the spinoglenoid notch. These branches supplies 70% of the sensory input to the shoulder.

In the literature, SSNB through suprascapular notch has positive effect on shoulder functions, pain and range of motion (ROM) in patients in the treatment of chronic shoulder pain. There is no study examining the efficacy of SSNB through spinoglenoid notch in the treatment of chronic shoulder pain.Therefore, the investigators planned this randomized trial to compare of the efficiency and safety of two different SSNB techniques (approach through suprascapular notch versus spinoglenoid notch) in treatment of patients with chronic shoulder pain.

Material and methods:

Participants: adult patients (>18 year old) with chronic shoulder pain Inclusion criteria: age ≥ 18 years old, shoulder pain that last more than 3 month, patients with a vas value of ≥ 4 despite treatment (drugs used for analgesia, local injections and physiotherapy methods), shoulder pain defined as non-specific shoulder pain, subacromial impingement syndrome, rotator cuff tendinopathy, adhesive capsulitis, non-traumatic instability, superior labrum anterior and posterior (SLAP) lesion, acromioclavicular pathology, shoulder osteoarthritis.

Exclusion criteria: A history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, previous surgery history at the affected shoulder, shoulder injection in the last 3 months before treatment, cervical radiculopathy or myelopathy, a previous fracture close to the shoulder region, septic arthritis or local infection in the affected shoulder, anaphylaxis against local anesthetics and/or corticosteroids, cardiac pacemaker, pregnancy.

Study Design: prospective, double blind, non-inferiority, randomized controlled trial Randomization method: 1:1 by computer randomization program

Detail of the intervention:

Experimental: SSNB through the spinoglenoid notch US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics Active comparator: SSNB through the suprascapular notch US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics

Outcome measurement:

Visual analogue scale of pain, active range of motion, shoulder pain and disability index (SPADI), Pain Pressure Threshold (PPT), Patient satisfaction

Statistical analyses:

Sample size calculation:

The sample size was calculated using http://statulator.com/SampleSize/ss2M.html considering a previous study. The non-inferiority margin for SPADI was taken as 9 points. Standard deviation 15.3 (assuming normal distribution) with a power of 80, an error of 0.05 type 1; 36 patients should be enrolled per groups. Including a rate of 10% drop-out 40 patients were planned to enroll in each groups.

Continuous variables

  1. Student's t test: fit assumption of normal distribution
  2. Mann-Whitney test: does not fit the assumption of normal distribution Categorical variables

1. Chi-square test 2. Fisher exact test: sparse data

The outcome differences within the experimental and active comparator groups of different time of evaluation will be analysed by using repeated-measures analysis of variance (ANOVA) with post hoc test with Bonferroni method.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38100
        • Erciyes University Faculty of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Shoulder pain that last more than 3 month
  3. Patients with a VAS value of ≥ 4 despite treatment (drugs used for analgesia, local injections and physiotherapy methods)
  4. Shoulder pain defined as non-specific shoulder pain, subacromial impingement syndrome, rotator cuff tendinopathy, adhesive capsulitis, non-traumatic instability, SLAP lesion, acromioclavicular pathology, and / or shoulder osteoarthritis.

Exclusion Criteria:

  1. A history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and infection
  2. Previous surgery history at the affected shoulder
  3. Shoulder injection in the last 3 months before treatment
  4. The presence of cervical radiculopathy or myelopathy
  5. A previous fracture close to the shoulder region
  6. Presence of septic arthritis or local infection in the affected shoulder
  7. Presence of anaphylaxis against local anesthetics and / or corticosteroids
  8. Presence of a cardiac pacemaker
  9. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSNB through the spinoglenoid notch
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
Procedure: US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine
nerve block
Active Comparator: SSNB through the suprascapular notch
US guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
Procedure: US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine
nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline and 1, 4, and 12 weeks after injection
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.
Baseline and 1, 4, and 12 weeks after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Range of Motion (ROM)
Time Frame: Baseline and 1, 4, and 12 weeks after injection
Active ROM of the affected shoulder is measured using a goniometer. These measurements included abduction, flexion, internal rotation, and external rotation.
Baseline and 1, 4, and 12 weeks after injection
Change of Visual Analog Scale (VAS)
Time Frame: Baseline and 1, 4, and 12 weeks after injection
The 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.
Baseline and 1, 4, and 12 weeks after injection
Change of Pain Pressure Threshold (PPT)
Time Frame: Baseline and 1, 4, and 12 weeks after injection
In 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.
Baseline and 1, 4, and 12 weeks after injection
Patient Satisfaction
Time Frame: 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)
Assessed at baseline and 1, 4, and 12 weeks after injection, with week 12 reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: İsa Cüce, Assist. Prof, Erciyes University Faculty of Medicine Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/353

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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