SPORTS MEDICINE JOURNAL CLUB Subacromial or Systemic Steroid Injection for Rotator Cuff Disease?

Objective: To compare the effectiveness of a systemic corticosteroid injection in the gluteal region with an ultrasoundguided injection in the subacromial bursa for patients with rotator cuff disease. Design: Randomized, controlled, doubleblind trial with follow-up at 2 and 6 weeks. The sample size was sufficient to detect a clinically relevant difference between groups of 10/100 points on the shoulder pain and disability index (SPADI). Setting: Patients were referred to an outpatient university clinic in Oslo, Norway. Participants: Inclusion criteria were: men and women $18 years of age, who had shoulder pain for . 3 months; pain on abduction; ,50% reduced glenohumeral range of motion in no more than 1 direction of external rotation, internal rotation, or abduction; pain on 2 of 3 isometric tests for abduction, external rotation, and internal rotation; and a positive Hawkins-Kennedy impingement sign. Exclusion criteria were other shoulder conditions, eg, arthritis, other joint pathology, referred pain or generalized pain; diabetes mellitus type 1, previous shoulder fractures; contraindications to, or recent, corticosteroid treatment; and a pain and disability index score, 30/100 points. The patients were all examined by 1 physician. Intervention: One consultant physician prepared and administered the injections according to a standard protocol. Both groups received sonographically guided injections of 5 mL lidocaine chloride (Xylocaine, AstraZeneca; 10 mg/mL) to the subacromial bursa and intramuscular injections of 2 mL (systemic injection group) or 4 mL (local injection group) lidocaine chloride to the upper gluteal region. In addition, the systemic group received 2 mL triamcinolone (Kenacort-T, Bristol-Myers Squibb; 10 mg/mL) to the gluteal region, whereas the local group received 2 mL triamcinolone in a sonographically guided injection into the subacromial bursa. Using an anterior approach, the injection into the subacromial bursa was done before the intramuscular injection. All patients could continue physiotherapy programs and use analgesia during the trial period. Main outcome measures: The main outcome measure was the SPADI after 2 and 6 weeks. This scale comprises the average of 5 pain and 8 disability selfadministered visual analog scales. Secondary measures were the Western Ontario rotator cuff (WORC) index, active range of abduction and flexion (measured by a blinded assessor), and the participant’s rating of change from baseline. Of 106 patients randomized, 3 missed the 6-week assessment; their results were carried forward in intention-to-treat analysis. Main results: On the SPADI, the groups both improved by 6 weeks (P , 0.001): mean baseline and 6-week scores for the systemic group and the local group were 51/100 and 53/100, and 32 and 29 (adjusted difference between groups in improvement:24.1; 95% CI,212.3–4.1; P = 0.32). The WORC index showed a greater improvement in the local group than in the systemic group (adjusted difference, 8.1; CI, 0.7–15.6) and participants in the local group reported greater median improvement in their main complaint than those in the systemic group (difference, 2.0; CI, 0–4.0). No differences were found in abduction or flexion or in pain at rest and during activity. Only 8 patients had normal, pain-free abduction and negative clinical tests. Nine patients reported mild adverse effects and 14 patients in the systemic group and 1 patient in the local group reported post-injection shoulder pain. Of the 63% of patients who answered the question about group allocation, 19 of 38 patients (50%) in the systemic group and 7 of 29 patients (24%) in the local group correctly identified their treatment group (P = 0.055). Conclusion: An ultrasound guided injection into the subacromial bursa, when compared with a systemic injection, did not make a clinically important difference over a 6-week period in shoulder pain and disability in patients with rotator cuff disease.