NCT04938037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

June 10, 2021

Results QC Date

April 1, 2025

Last Update Submit

May 19, 2025

Conditions

Chronic Shoulder Pain

Keywords

chronic shoulder painspinoglenoid notchsuprascapular nerve blocksuprascapular notch

Outcome Measures

Primary Outcomes (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.

    Baseline and 1, 4, and 12 weeks after injection

Secondary Outcomes (4)

  • Change of Visual Analog Scale (VAS)

    Baseline and 1, 4, and 12 weeks after injection

  • Change of Range of Motion (ROM)

    Baseline and 1, 4, and 12 weeks after injection

  • Change of Pain Pressure Threshold (PPT)

    Baseline and 1, 4, and 12 weeks after injection

  • Patient Satisfaction

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

Study Arms (2)

SSNB through the spinoglenoid notch

EXPERIMENTAL

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

SSNB through the suprascapular notch

ACTIVE COMPARATOR

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

Interventions

US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacainePROCEDURE

nerve block

SSNB through the spinoglenoid notchSSNB through the suprascapular notch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Medicine Hospital

Kayseri, 38100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 33185375BACKGROUND

  • 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.

    PMID: 21654552BACKGROUND

  • 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.

    PMID: 31036420BACKGROUND

  • 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.

    PMID: 18262803BACKGROUND

  • 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.

    PMID: 26701762BACKGROUND

  • 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.

    PMID: 12695149BACKGROUND

MeSH Terms

Interventions

Methylprednisolone AcetateBupivacaine

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Chronic shoulder pain is a clinical spectrum that includes a heterogeneous group of diagnoses. The effectiveness of two different SSNB methods may differ in certain diagnostic groups.

Results Point of Contact

Title
Dr. Isa Cuce
Organization
ErciyesU
dr.icüce@hotmail.com
+905056263723

Study Officials

  • İsa Cüce, Assist. Prof

    Erciyes University Faculty of Medicine Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 24, 2021

Study Start

June 1, 2021

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

May 20, 2025

Results First Posted

May 20, 2025

Record last verified: 2025-05

Locations

TU(1)