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

Primary Purpose

Shoulder Impingement Syndrome, Adhesive Capsulitis of Shoulder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection
Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Glenohumeral injection, Subacromial injection, Ultrasound-guided injection, Steroid injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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˚. Exclusion Criteria: 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

Sites / Locations

  • Chuncheon Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glenohumeral injection

Subacromial injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual analog scale (VAS) for pain
Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain
Range of motion (ROM)
ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)
American Shoulder and Elbow Surgeons (ASES) shoulder score
Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Constant score
Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
September 21, 2023
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06051370
Brief Title
Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Shoulder Stiffness
Official Title
Ultrasound-guided Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Stiffness: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2013 (Actual)
Primary Completion Date
March 17, 2014 (Actual)
Study Completion Date
June 18, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patient Enrollment Following approval from the Institutional Review Board and in compliance with the Declaration of Helsinki, a prospective randomized controlled trial was conducted from January 2013 to June 2014, involving 56 patients diagnosed with shoulder impingement syndrome with mild stiffness. Impingement syndrome was diagnosed based on positive Hawkin's sign and radiographic findings (rotator cuff with intact continuity but tendinosis confirmed by MRI or ultrasound, with a possible subacromial enthesophyte). "Mild" stiffness was defined in this study as a degree of stiffness that permits activities of daily activity but still often causes endpoint ROM pain. It was specified as meeting two or more of the following criteria in shoulder range of motion both passive and active: abduction between 110˚ and 150˚, forward elevation between 120˚ and 140˚, external rotation at the side between 30˚ and 50˚, and internal rotation at 90˚ of abduction between 30˚ and 50˚. Patients were excluded from the study if they (1) refused to undergo ultrasound-guided injection, (2) were diagnosed with a rotator cuff tear, calcific tendinosis, or biceps pathology, (3) had a history of operation, fracture, or nerve injury of the shoulder, or (4) received treatment apart from the protocol during the study. 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 (M. S. H.) with over 20 years of experience performed the diagnostic ultrasound and MRI interpretations. A shoulder specialist (J.-T. H.) with more than 10 years of experience performed the ultrasound-guided injections. A blinded orthopaedic resident and nurse carried out the physical examination and clinical scoring. After the final follow-up, 48 patients (24 in each group) were eligible for analysis Treatment and Follow-up Protocol Diagnostic ultrasound was first done using a 5- to 12-MHz linear probe (Philips Healthcare, Bothell, WA) to rule out shoulder pathology other than impingement syndrome. Using a 21-gauge spinal needle, a solution of 1mL triamcinolone, 4mL 1% lidocaine, and 7mL 0.9% normal saline was injected under ultrasound guidance using 5- to 13-MHz linear probe (GE Healthcare, Chicago, IL) into either the glenohumeral space through the posterior approach or the subacromial space through the anterolateral approach. Patients were then seen in 3, 7, and 13 weeks after the injection. Oral aceclofenac 100 mg twice daily and omeprazole 20mg once daily were prescribed during follow-up. Stretching exercises in all ranges of motions commenced in the third week. Using a wand, patients were instructed to passively stretch their shoulders to an endpoint where pain is felt and keep that position for at least 30 seconds, five sessions a day, five minutes per session. Rubber band strengthening was added in the seventh week, concentrating on external rotation at the side. Using a rubber band (Thera-band, Hygienic Corp., Akron, OH) tied into a loop, the patients were educated to keep maximum painless external rotation for 30 seconds, five sessions a day, five minutes per session. The tension of the rubber band was decided depending on the patients' ability to keep the painless maximum rotation for thirty seconds. Clinical Assessment and Data Collection Patient information, including age, sex, duration of symptoms, affected side, and hand dominance, was recorded. The following assessments were performed at baseline and at follow-up visits in weeks 3, 7, and 13: range of motion (ROM) in forward elevation (FE), external rotation at the side (ER), and internal rotation at 90˚ of abduction (IR), pain visual analog scale (pVAS), American Shoulder and Elbow Surgeons (ASES) score, and the Constant-Murley (Constant) score. The ASES score was chosen as it was much verified to best reflect the activities of daily living, while strength was evaluated through the Constant score Improvement in ROM was calculated by subtracting the pre-injection measurements from the measurements at each follow-up visit. Statistical Analysis A power analysis determined that a sample size of 42 patients (21 per group) would be sufficient to have an 80% statistical power to detect a significant difference in the improvement of the Constant score between pre-injection and 7-week post-injection, with a two-sided α level of 0.05. An effect size of 0.89 was assumed based on the mean difference and standard deviation of improvement in the Constant score between pre-injection and 7-week post-injection in a pilot study of 20 patients. Normal distribution was checked using the Kolmogorov-Smirnov test. The independent-samples t test or the Mann-Whitney U test were used to analyze continuous data, while the paired-sample t test was used for intra-group comparison of serial measurements. Categorical data were analyzed using Pearson's chi-squared test. Continuous data were described as mean ± SD, and categorical data as a percentage. Analyses were performed using SPSS version 25 (IBM Corporation, Armonk, NY), and a P-value below 0.05 was considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Adhesive Capsulitis of Shoulder
Keywords
Glenohumeral injection, Subacromial injection, Ultrasound-guided injection, Steroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glenohumeral injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Subacromial injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) for pain
Description
Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain
Time Frame
Change from the baseline at 13 weeks
Title
Range of motion (ROM)
Description
ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)
Time Frame
Change from the baseline at 13 weeks
Title
American Shoulder and Elbow Surgeons (ASES) shoulder score
Description
Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Time Frame
Change from the baseline at 13 weeks
Title
Constant score
Description
Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Time Frame
Change from the baseline at 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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˚. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Taek Hwang, MD, PhD
Organizational Affiliation
Chuncheon Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwondo
ZIP/Postal Code
700-204
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22052646
Citation
Harrison AK, Flatow EL. Subacromial impingement syndrome. J Am Acad Orthop Surg. 2011 Nov;19(11):701-8. doi: 10.5435/00124635-201111000-00006.
Results Reference
background
PubMed Identifier
22047785
Citation
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.
Results Reference
background
PubMed Identifier
15789007
Citation
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.
Results Reference
background
PubMed Identifier
20595136
Citation
Wright RW, Baumgarten KM. Shoulder outcomes measures. J Am Acad Orthop Surg. 2010 Jul;18(7):436-44. doi: 10.5435/00124635-201007000-00006.
Results Reference
background
PubMed Identifier
3791738
Citation
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
Results Reference
background

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

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