Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Shoulder Stiffness
Condition: Shoulder Impingement Syndrome; Adhesive Capsulitis of Shoulder
MeSH terms: Bursitis; Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

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.
    

Intervention name(s): Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection; Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; 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
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glenohumeral injection; Subacromial injection; Ultrasound-guided injection; Steroid injection