Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial

Abstract

Objective: To determine whether arthrographic distension with a mixture of saline and steroid, in patients with painful stiff shoulder for at least 3 months, is better than placebo in improving function, pain, and range of motion at 3, 6, and 12 weeks. Methods: A randomised, placebo controlled trial with participant and outcome assessor blinding in which shoulder joint distension with normal saline and corticosteroid was compared with placebo (arthrogram). Outcome measures, assessed at 3, 6, and 12 weeks, included a shoulder-specific disability measure (SPADI), a patient preference measure (Problem Elicitation Technique (PET)), pain, and range of active motion. Results: From 96 potential participants, 48 were recruited. Four withdrew from the placebo group after the 3 week assessment and three subsequently received arthrographic distension with saline and steroid. At 3 weeks, significantly greater improvement in SPADI (p = 0.005), PET, overall pain, active total shoulder abduction, and hand behind back was found in participants in the joint distension and steroid group than in the placebo group. At 6 weeks the results of the intention to treat analysis favoured joint distension, although the between-group differences were only significant for improvement in PET (difference in mean change in PET between groups = 45.9 (95% CI 3.2 to 88.7). Excluding the four withdrawals, the betweengroup differences for the disability and pain measures significantly favoured distension over placebo. At 12 weeks, both the intention to treat analysis and an analysis excluding the four withdrawals demonstrated a significantly greater improvement in PET score for the distension group. Conclusions: Short term efficacy of arthrographic distension with normal saline and corticosteroid over placebo was demonstrated in patients with painful stiff shoulder.

Management of frozen shoulder: a systematic review and cost-effectiveness analysis

“…0-9 in the case of a Likert 0-9 scale used to measure pain) to identify sequences whose mean equalled the mean reported in the trial of interest. Where the two means matched, the model calculated a SD; finally, the mean of these SDs was calculated and used in our analysis (two studies 42,43 ). The R code is presented in Appendix 3.…”

“…A summary of study characteristics is reported in Table 42, with further details available in Appendix 6. All were full papers of studies conducted in Australia, 43 Denmark 84 and Norway 36 and published between 1998 and 2008. All were two-armed trials.…”

“…The two most recent studies by Buchbinder et al 43 and Tvetia et al 36 used arthrographic distension. One injected 40 mg of steroid (in 1 ml) and up to 82 ml of saline on a single occasion 43 and the other injected 20 mg of steroid (2 ml), 4 ml of local anaesthetic and 10 ml of saline on three occasions at 2-week intervals, 36 along with contrast medium in the arthrographic distension groups.…”

“…One injected 40 mg of steroid (in 1 ml) and up to 82 ml of saline on a single occasion 43 and the other injected 20 mg of steroid (2 ml), 4 ml of local anaesthetic and 10 ml of saline on three occasions at 2-week intervals, 36 along with contrast medium in the arthrographic distension groups. Both of these studies stated that the procedure continued until rupture occurred.…”

“…Both of these studies stated that the procedure continued until rupture occurred. Buchbinder et al 43 had the additional end points of patient termination of the procedure and a maximum of 90 ml having been injected. The older study by Gam et al 84 stated that the injection was confirmed by ultrasound and participants were injected with 20 mg of steroid with 19 ml of lidocaine once per week for up to 6 weeks.…”