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

Not Applicable

Completed

Conditions: Chronic Shoulder Pain

Interventions: Procedure: US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine

Registration Number: NCT04938037

Lead Sponsor: TC Erciyes University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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, SLAP lesion, acromioclavicular pathology, and / or shoulder osteoarthritis.

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of Shoulder Pain and Disability Index (SPADI)	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.

Secondary Outcome Measures

Name	Time	Method
Change of Visual Analog Scale (VAS)	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.
Change of Range of Motion (ROM)	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.
Change of Pain Pressure Threshold (PPT)	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.
Patient Satisfaction	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)