The study included 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.
Main outcome measures were shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.
In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were −4.6 (95% confidence interval −11.3 to 2.1) points (P=0.18) at rest and −9.0 (−18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events.
In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (−7.5, −14.0 to −1.0, points; P=0.023) and VAS on arm activity (−12.0, −20.9 to −3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group.
In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over the "sham" procedure of diagnostic arthroscopy at 24 months.
The results of this study are consistent with that of another recent randomized controlled trial:
Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.
These authors point out that arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain.
These authors point out that arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain.
They performed aa multicenter, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. They randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted.
Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat.
They randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment.
Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group).
They concluded that the surgical groups had better outcomes for shoulder pain and function compared with no treatment, but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. They state that their findings question the value of this operation for these indications, and that this should be communicated to patients during the shared treatment decision-making process.
They concluded that the surgical groups had better outcomes for shoulder pain and function compared with no treatment, but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. They state that their findings question the value of this operation for these indications, and that this should be communicated to patients during the shared treatment decision-making process.
Comment: These two well done randomized trials do not demonstrate value to the patient for one of the most commonly performed shoulder surgeries: the subacromial decompression. Discussers of these papers have come to some dramatic conclusions:
"Based on these results, we should question the current line of treatment according to which patients with shoulder pain attributed to shoulder impingement are treated with decompression surgery, as it seems clear that instead of surgery, the treatment of such patients should hinge on nonoperative means," Järvinen states. "By ceasing the procedures which have proven ineffective, we would avoid performing hundreds of thousands useless surgeries every year in the world," Järvinen points out. "Fortunately, there seems to be light at the end of the tunnel as the NHS in England just released a statement that they will start restricting funding for 'unnecessary procedures' and the list includes subacromial decompression. We applaud this initiative and encourage other countries to follow this lead."
"We have to spend taxpayers' money responsibly. If we are spending money on procedures that are not effective, that money is deprived from treatments that are clinically effective and would provide benefits to patients. One component in becoming more efficient is to make sure we are not undertaking unnecessary procedures,"
===
"Based on these results, we should question the current line of treatment according to which patients with shoulder pain attributed to shoulder impingement are treated with decompression surgery, as it seems clear that instead of surgery, the treatment of such patients should hinge on nonoperative means," Järvinen states. "By ceasing the procedures which have proven ineffective, we would avoid performing hundreds of thousands useless surgeries every year in the world," Järvinen points out. "Fortunately, there seems to be light at the end of the tunnel as the NHS in England just released a statement that they will start restricting funding for 'unnecessary procedures' and the list includes subacromial decompression. We applaud this initiative and encourage other countries to follow this lead."
"We have to spend taxpayers' money responsibly. If we are spending money on procedures that are not effective, that money is deprived from treatments that are clinically effective and would provide benefits to patients. One component in becoming more efficient is to make sure we are not undertaking unnecessary procedures,"
===
We have a new set of shoulder youtubes about the shoulder, check them out at this link.
Be sure to visit "Ream and Run - the state of the art" regarding this radically conservative approach to shoulder arthritis at this link and this link
Use the "Search" box to the right to find other topics of interest to you.
You may be interested in some of our most visited web pages arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'
