Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Shoulder Stiffness

NCT06051370 | Completed DMC

• 1 other identifier: Stiff Impinge - GH vs SA
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized controlled trial enrolled 51 patients diagnosed with shoulder impingement syndrome and mild stiffness. Patients were randomly assigned to two groups: the glenohumeral injection group (Group GH) or the subacromial injection group (Group SA). After the final follow-up, 48 patients (24 in each group) were included for analysis Using ultrasound guidance, a solution containing 1mL of triamcinolone, 4mL of 1% lidocaine, and 7mL of 0.9% normal saline was injected into either the glenohumeral or the subacromial space. The following assessments were conducted at baseline and during follow-up visits at weeks 3, 7, and 13: ROM measurements for forward elevation, external rotation, and internal rotation; clinical scores including VAS, ASES, and Constant.

Conditions

Shoulder Impingement Syndrome; Adhesive Capsulitis of Shoulder

Keywords

Glenohumeral injection; Subacromial injection; Ultrasound-guided injection; Steroid injection

Outcome Measures

Primary Outcomes (4)

• Visual analog scale (VAS) for pain

  Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain

  Change from the baseline at 13 weeks

• Range of motion (ROM)

  ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)

  Change from the baseline at 13 weeks

• American Shoulder and Elbow Surgeons (ASES) shoulder score

  Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.

  Change from the baseline at 13 weeks

• Constant score

  Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.

  Change from the baseline at 13 weeks

Study Arms (2)

Glenohumeral injection

EXPERIMENTAL

Ultrasound-guided posterior approach of glenohumeral space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.

Procedure: Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection

Subacromial injection

ACTIVE COMPARATOR

Ultrasound-guided anterolateral approach of subacromial space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.

Procedure: Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection

Interventions

Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection PROCEDURE

Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach

Glenohumeral injection

Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection PROCEDURE

Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the subacromial space through the anterolateral approach

Subacromial injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with shoulder impingement syndrome with mild stiffness.
• Impingement syndrome diagnosed based
• Positive Hawkin's sign and
• Rotator cuff with intact continuity but tendinosis in MRI or US
• Possible subacromial enthesophyte
• Mild stiffness was defined as a degree of stiffness that permits activities of daily activity but still often causes endpoint ROM pain
• Meeting two or more of the following ROM both active \& passive
• Abduction between 110˚ and 150˚
• Forward elevation between 120˚ and 140˚
• External rotation at the side between 30˚ and 50˚
• Internal rotation at 90˚ of abduction between 30˚ and 50˚.

You may not qualify if:

• Refused to undergo ultrasound-guided injection
• Diagnosed with a rotator cuff tear, calcific tendinosis, or biceps pathology
• History of operation, fracture, or nerve injury of the shoulder
• Received treatment apart from the protocol during the study

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 700-204, South Korea

Location

Related Publications (5)

• Harrison AK, Flatow EL. Subacromial impingement syndrome. J Am Acad Orthop Surg. 2011 Nov;19(11):701-8. doi: 10.5435/00124635-201111000-00006.

  PMID: 22052646 BACKGROUND

• Namdari S, Yagnik G, Ebaugh DD, Nagda S, Ramsey ML, Williams GR Jr, Mehta S. Defining functional shoulder range of motion for activities of daily living. J Shoulder Elbow Surg. 2012 Sep;21(9):1177-83. doi: 10.1016/j.jse.2011.07.032. Epub 2011 Nov 1.

  PMID: 22047785 BACKGROUND

• Mathews PV, Glousman RE. Accuracy of subacromial injection: anterolateral versus posterior approach. J Shoulder Elbow Surg. 2005 Mar-Apr;14(2):145-8. doi: 10.1016/j.jse.2004.06.012.

  PMID: 15789007 BACKGROUND

• Wright RW, Baumgarten KM. Shoulder outcomes measures. J Am Acad Orthop Surg. 2010 Jul;18(7):436-44. doi: 10.5435/00124635-201007000-00006.

  PMID: 20595136 BACKGROUND

• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

  PMID: 3791738 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Bursitis

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jung-Taek Hwang, MD, PhD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A final number of 51 patients were enrolled in the trial and randomly assigned to either the glenohumeral ultrasound-guided injection group (Group GH) or the subacromial ultrasound-guided injection group (Group SA). Double-blinded randomization was performed by an independent nurse using a computer-generated random sequence. A musculoskeletal radiologist, blinded to group allocation, performed the diagnostic ultrasound and MRI interpretations. A blinded orthopaedic resident and nurse carried out the physical examination and clinical scoring.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study group underwent ultrasound-guided posterior approach of glenohumeral space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline. Control group underwent ultrasound-guided anterolateral approach of subacromial space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: January 12, 2013
• Primary Completion: March 17, 2014
• Study Completion: June 18, 2014
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)