Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care

Abstract

BackgroundOptimal management for adhesive shoulder capsulitis (frozen shoulder) is currently unclear. We intended to explore whether treatment by intra-articular injections with corticosteroid and distension is more effective than treating with corticosteroids alone or treatment-as-usual in a primary care setting in Norway.MethodsIn this prospective randomised intention to treat parallel study, 106 patients were block randomised to three groups; 36 (analysed 35) receiving steroid injection and Lidocaine (IS), 34 receiving steroid and additional saline as distension (ISD) and 36 had treatment-as-usual (TAU). Intervention groups received four injections within 8 weeks, assessed on 1st visit, at the 4th and 8th week. Outcomes were Shoulder Pain and Disability Index (SPADI), Numerical pain rating scale (NPRS) and passive range of motion (PROM). Postal assessment was repeated after 1 year for SPADI. Patients in the IS and ISD groups were “blinded” for intervention received and the assessor was “blinded” to group allocation.ResultsAt baseline there were no differences between groups in outcome measures. There were no statistical significant differences between the intervention groups in SPADI, NPRS and PROM at baseline, at short-term (4-and 8 weeks) or long-term (12 months). There were statistically significant differences (p < 0.01) in change scores at short-term for SPADI when comparing the IS and TAU groups (-20.8; CI-28.9 to -12.7), and the ISD and TAU groups (-21.7; CI-29.4 to -14.0), respectively for NPRS (-2.0; CI-2.8 to -1.1 and -2.2; CI-3.0 to -1.4), and for PROM, but not at long-term for SPADI (p > 0.05).Effect size (ES) at 8 weeks was large between both injection groups and TAU (ES 1.2). At 12 months ES was reduced to 0.3 and 0.4 respectively. Transitory side effects as flushing and after-pain were reported by 14 % in intervention groups.ConclusionThis intention to treat RCT in primary care indicates that four injections with corticosteroid with or without distension, given with increasing intervals during 8 weeks, were better than treatment-as-usual in treatment of adhesive shoulder capsulitis. However, in the long run no difference was found between any of the groups, indicating that natural healing takes place independent of treatment or not.Trial registrationClinicalTrials.gov, https://clinicaltrials.gov/ identifier: NCT01570985

Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review

“…As described by both Yoon et al [23] and Tveita et al [37], "during the injection, the joint was gradually distended, making the axillary and subscapular recesses more visible," demonstrating that pathologic structures experienced little to no distension. This is in contrast to studies in this review that used a posterior approach whereby the joint was accessed superiorly at the level of the scapular spine, and in which the patients demonstrated significant benefit [20], trend toward benefit [19], or no benefit [24]. This approach allows for more target dilatation of the anterior-superior aspect, explaining some of the benefit experienced by these patients.…”

“…Sharma et al demonstrated in 106 shoulders that hydrodilatation with triamcinolone, lidocaine, and sodium chloride for a total injectate volume of 8‐20 mL was not superior at the 4‐week, 8‐week, or 12‐month follow‐up compared to intra‐articular injection of triamcinolone and lidocaine [24]. Patients in both intervention groups received injections via a landmark‐based posterior approach on the day of randomization and after 7, 17, and 31 days from the start, with outcome measured being evaluated by a blinded assessor at 4 weeks and 8 weeks.…”

“…The improvements in pain and ROM seen in the studies previously discussed was also documented by Yoon et al [23] at 1 month; however there was no appreciable improvement at long-term follow-ups of 3 and 6 months. In contrast, Tveita et al [21] and Sharma et al [24] demonstrated no difference at 1-and 2-month followup, or at 1-year follow-up demonstrated by Sharma et al between patients receiving the combined intervention versus corticosteroid injection alone. One of the reasons for this large variability in effectiveness among randomized controlled trials may stem from the technique used to dilate the glenohumeral capsule in each study.…”

“…Sharma [24] follow-up. This benefit was also experienced in patients in the Jacobs et al [19] study.…”

Shoulder Stiffness – How to Treat?

“…In a randomised, intention-to-treat parallel study, repeated steroid injections (4 injections at increasing intervals during 8 weeks) led to earlier pain relief and improved functional recovery of the affected shoulder, which were superior to the control group. During follow-up for 12 months, however, no difference was found between the groups [32].…”