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Chronic Shoulder PainNCT04938037

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

A study testing US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine in people with Chronic Shoulder Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Shoulder Pain
What is being tested?
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2021to 5 Aug 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Presence of anaphylaxis against local anesthetics and / or corticosteroids
  • Presence of a cardiac pacemaker
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erciyes University Faculty of Medicine Hospital

    Kayseri, 38100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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
  3. 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.

Being tested
US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine
Keywords
chronic shoulder pain, spinoglenoid notch, suprascapular nerve block, suprascapular notch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaineProcedure or surgery

    nerve block

Study groups in NCT04938037
Study groupRoleWhat they receive
SSNB through the spinoglenoid notchExperimentalUS guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
Receives: Procedure: US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine
SSNB through the suprascapular notchActive comparatorUS guided 1ml methylprednisolone acetate (1ml / 40mg) and 5ml 0.5% bupivacaine Intervention: Medication: corticosteroids and local anesthetics
Receives: Procedure: US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Shoulder Pain and Disability Index (SPADI)

    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.

    Measured: Baseline and 1, 4, and 12 weeks after injection

Secondary outcomes (4)
  1. Change of Visual Analog Scale (VAS)

    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.

    Measured: Baseline and 1, 4, and 12 weeks after injection

  2. Change of Range of Motion (ROM)

    Active ROM of the affected shoulder is measured using a goniometer. These measurements included abduction, flexion, internal rotation, and external rotation.

    Measured: Baseline and 1, 4, and 12 weeks after injection

  3. Change of Pain Pressure Threshold (PPT)

    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.

    Measured: Baseline and 1, 4, and 12 weeks after injection

  4. Patient Satisfaction

    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)

    Measured: Assessed at baseline and 1, 4, and 12 weeks after injection, with week 12 reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion5 Aug 2022
  4. Study completion5 Aug 2022

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04938037
Sponsor's protocol ID
2021/353
Status last verified
May 2025
First submitted
10 Jun 2021
Last updated
20 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Saglam G, Alisar DC. A Comparison of the Effectiveness of Ultrasound-Guided Versus Landmark-Guided Suprascapular Nerve Block in Chronic Shoulder Pain: A Prospective Randomized Study. Pain Physician. 2020 Nov;23(6):581-588.

    PubMed 33185375
  • Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.

    PubMed 21654552
  • Laumonerie P, Blasco L, Tibbo ME, Bonnevialle N, Labrousse M, Chaynes P, Mansat P. Sensory innervation of the subacromial bursa by the distal suprascapular nerve: a new description of its anatomic distribution. J Shoulder Elbow Surg. 2019 Sep;28(9):1788-1794. doi: 10.1016/j.jse.2019.02.016. Epub 2019 Apr 26.

    PubMed 31036420
  • Vorster W, Lange CP, Briet RJ, Labuschagne BC, du Toit DF, Muller CJ, de Beer JF. The sensory branch distribution of the suprascapular nerve: an anatomic study. J Shoulder Elbow Surg. 2008 May-Jun;17(3):500-2. doi: 10.1016/j.jse.2007.10.008. Epub 2008 Feb 11.

    PubMed 18262803
  • Chang KV, Hung CY, Wu WT, Han DS, Yang RS, Lin CP. Comparison of the Effectiveness of Suprascapular Nerve Block With Physical Therapy, Placebo, and Intra-Articular Injection in Management of Chronic Shoulder Pain: A Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2016 Aug;97(8):1366-80. doi: 10.1016/j.apmr.2015.11.009. Epub 2015 Dec 14.

    PubMed 26701762
  • Shanahan EM, Ahern M, Smith M, Wetherall M, Bresnihan B, FitzGerald O. Suprascapular nerve block (using bupivacaine and methylprednisolone acetate) in chronic shoulder pain. Ann Rheum Dis. 2003 May;62(5):400-6. doi: 10.1136/ard.62.5.400.

    PubMed 12695149

Questions about this trial

What is this clinical trial studying?

A study testing US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine in people with Chronic Shoulder Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).

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 4 inclusion and 9 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 20 May 2025. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Shoulder Pain and Disability Index (SPADI) (time frame: Baseline and 1, 4, and 12 weeks after injection). 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 NCT04938037, which also lists 6 linked publications.

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 20 May 2025.

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