Ultrasound-Guided Glenohumeral Steroid Injection
Condition: Adhesive Capsulitis of Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The investigators compared the results of the ultrasound-guided anterior and posterior
      approaches to administer glenohumeral steroid injections to patients with primary adhesive
      capsulitis of the shoulder joint by a single experienced provider.
    

Detailed description: 
      This study was a randomized controlled trial of 50 patients, who underwent history taking,
      physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with primary
      adhesive capsulitis of the shoulder from December 2012 to November 2013. The 50 patients were
      assigned to Group I (anterior approach) or Group II (posterior approach) under double-blinded
      randomization. The randomization was performed by an independent nurse using a computerized
      random sequence generator. The operators who participated in the procedure were blinded to
      the participant's information. The injection mixture for both groups was: 1 mL triamcinolone,
      4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics
      Healthcare). After the injection, anteroposterior, scapular lateral, and axillary x-rays of
      the shoulder were taken of all patients within 15 min, and leakage was classified into three
      categories by a musculoskeletal radiologist with 18 years experience: 1) no leakage; 2)
      leakage; and 3) cannot be determined. Injection accuracy was defined as [number of 1) ÷
      {number of 1) + number of 2) + number of 3)}] × 100 (%). The frequency of needling until the
      injection had been completed was checked. A visual analog scale (VAS) for pain, range of
      motion (ROM), patient's satisfaction (SAT), the American Shoulder and Elbow Surgeons (ASES)
      shoulder score, and the Constant score were recorded before, and 3, 7, and 13 weeks after the
      injection. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe
      pain ever experienced. Internal rotation was measured from buttock to T5 in this study, with
      the range between L5 and T5 being allocated a sequential value between 2 and 13 and the range
      below the first sacral vertebra being allocated 1. SAT was also selected from a scale of 0 to
      10, with 0 being unsatisfactory and 10 being very satisfactory. Stick exercises were started
      at 3 weeks, and theraband exercises were started 7 weeks after the injection.

      Two patients of 54 patients who had been assessed for eligibility in this study were excluded
      due to proximal humerus fractures of the affected shoulders. And another two participants
      were excluded because they had declined to participate. One Group I patient was excluded due
      to an additional subacromial injection 3 weeks after the study injection. And another Group I
      patient was excluded due to loss of follow-up before 13 weeks. Also, two patients were
      excluded from Group II because of loss to follow-up. Finally, 46 patients were included in
      the study (n = 23/group). The demographic data of the two groups were not significantly
      different.

      Diagnostic ultrasonography was performed by a musculoskeletal radiologist with 18 years
      experience using ultrasound (Philips Healthcare) before the injection. The ultrasound-guided
      glenohumeral steroid injection was administered by a shoulder and elbow surgeon who performed
      more than 2,000 similar procedures.

      A 21-gauge spinal needle was used for all of the ultrasound-guided steroid injections. The
      patient was supine with the shoulder slightly rotated externally for the anterior approach.
      The shoulder was draped in sterile fashion using 70% alcohol and povidone-iodine solution.
      The linear ultrasonography probe (General Electronics Healthcare) was prepared with 70%
      alcohol and a thin layer of sterile ultrasonographic transmission gel (Republic of Korea).
      The needle was inserted at the level of the coracoids, from lateral to medial, and was aimed
      at the medial border of the humeral head, parallel to the longitudinal axis of the probe. The
      posterior approach was performed with the patient in the lateral decubitus position on the
      unaffected side, leaning 45 degree anteriorly and hugging a pillow. The needle was inserted
      from lateral to medial, parallel to the longitudinal axis of the probe, and into the joint
      between the humeral head and the posterior glenoid labrum.

      The participants took off their coats and shirts in the injection room. Females wore a skirt
      at the axillary level exposing the shoulder for injection. The provider entered the injection
      room and positioned the patients appropriately. Just after positioning, the operator put on
      gloves, prepared the injection mixture, and administered the injection. Positioning time
      (from operator entering the room until the end of positioning) and injection time (from
      putting on gloves until just after the injection) were recorded by an independent nurse. The
      sum of the two times was recorded as the total time, and the frequency of needling during the
      injection for one patient was also recorded.

      A power analysis indicated that a sample size of 46 patients (23/group) would provide a
      statistical power of 80%, with a two-sided α level of 0.05 to detect a significant difference
      in the improvement of ASES score between initial and 13 weeks after injection, assuming an
      effect size of 0.85 (mean difference, 16.1; standard deviation, 19.0). This was based on the
      mean and standard deviation of the improvement of ASES score between initial and 13 weeks
      after injection observed in a pilot study of 20 patients.

      The Wilcoxon signed-rank test was used to compare preoperative and postoperative data.
      Normally distributed data between the groups were analyzed using the independent sample
      t-test. Otherwise, the nonparametric Mann-Whitney U-test was used. Statistical analyses were
      performed with SPSS ver. 13.0 software (SPSS Inc., Chicago, USA). A p value < 0.05 was
      considered statistically significant.
    

Intervention name(s): Glenohumeral triamcinolone injection by anterior approach; Glenohumeral triamcinolone injection by posterior approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).; Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment