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.

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

Shoulder Impingement Syndrome

Adhesive Capsulitis of Shoulder

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.

Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection

Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection

Ultrasound-guided Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Stiffness: A Randomized Controlled Trial

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

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

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

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

Professor

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.

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

About this trial

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