Arthroscopic subacromial decompression surgery does not reduce pain any more than arthroscopy alone in people with shoulder impingement, researchers say.
“[T]he findings from our study suggest that surgery might not provide a clinically significant benefit over no treatment, and that there is no benefit of decompression over placebo surgery,” said Andrew Carr, ChM, DSc, from the National Institute of Health Research Biomedical Research Centre, University of Oxford, United Kingdom, in a news release.
Dr Carr and colleagues published the finding online November 20 in the Lancet.
In the United States, 4.5 million patient visits per year result from shoulder pain. For subacromial pain, treatment options include decompressing the subacromial space by removing bone spurs and soft tissue arthroscopically. It is one of the most common surgeries in orthopedics. In England, the number of such surgeries has risen from 2523 in 2000 to 21,355 in 2010.
“Over the past three decades, patients with this form of shoulder pain and clinicians have accepted this surgery in the belief that it provides reliable relief of symptoms, and has low risk of adverse events and complications,” Dr Carr said in the release.
But as far as he and his colleagues could tell, the procedure had never been tested in a placebo-controlled trial. To fill that gap, they recruited people from 32 hospitals around the United Kingdom who had intact rotator cuff tendons but had experienced subacromial pain for at least 3 months, despite physical therapy and steroid injections.
The researchers randomly assigned 90 of these people to decompression surgery, 94 to arthroscopy without removing any tissue, and 90 to no treatment. The patients undergoing surgery did not know which treatment they received.
Surgery participants also had one to four physical therapy sessions afterward, whereas those having no treatment only had a check-up appointment 3 months after the start of the trial.
Six and 12 months after they entered the trial, the participants completed questionnaires rating their symptoms, including on the Oxford Shoulder Score, a scale of 0 to 8, with a higher number meaning less pain.
At baseline, people who had had decompression surgery rated their pain and function at a mean of 25.2 (standard deviation [SD], 8.5) points. Six months after the surgery, they rated their pain at 32.7 (SD, 11.6) points.
Among those who had arthroscopy alone, the baseline score improved from a mean of 26.7 (SD, 8.8) points to 34.2 (SD, 9.2) points.
Those who had no treatment improved from a mean of 25.5 (SD, 8.3) to 29.4 (SD, 11.9) points.
The difference between the two surgery groups was not statistically significant (P = .3141).
The difference between those who received decompression surgery and those who received no treatment was statistically significant (P = .0186), as was the difference between those who received arthroscopy and those who received no treatment (P = .0014).
The patients scored their pain as further reduced at 12 months, but the comparison among groups remained the same; there were statistically significant but small differences between both groups of patients who had surgery and the group that did not, but no statistical difference between the two groups of surgery patients.
Tests on other scales, such as the Constant-Murley score, PainDETECT, EuroQol 5 dimensions 3 level index, quality of life index, EuroQol visual analogue scale, and Hospital Anxiety and Depression showed similar patterns.
The authors speculate the difference between surgery and no treatment could be attributable to a placebo effect related to surgery, a nocebo effect related to having no treatment, other unintended effects of the arthroscopy, or the physical therapy and rest prescribed to the patients who underwent surgery. In any event, they write, “these differences were not clinically important.”
During the trial, six participants had a frozen shoulder (two people in each treatment group) related to the study.
The researchers acknowledge some limitations to their study. Most important, a high proportion of patients did not continue with their assigned treatment: 23% of those who underwent decompression surgery, 42% of those who underwent arthroscopy, and 12% of those who received no treatment.
Some patients assigned to surgery did not undergo treatment because their symptoms improved, and other patients assigned to no treatment chose to undergo decompression surgery.
However, the results remained valid whether the authors analyzed the results per protocol or intention-to-treat.
In addition, there were long waiting times within the study. Some people who had only recently had surgery and may have still been recovering were compared with people who had had no treatment for 6 months. On average, people assigned to decompression surgery waited 90 days for their surgery, and people assigned to placebo surgery waited 82 days.
The study did not look at the recurrence of pain beyond a year, but it is unlikely that the differences between groups would increase after that amount of time, the researchers write.
“Our findings call into question the value of shoulder decompression surgery for this group of patients, and should be communicated to patients and doctors considering this type of surgery,” coauthor David Beard, DPhil, also from the University of Oxford, said in the press release.
In an accompanying commentary, Berend Schreurs, MD, PhD, from Radboud University Medical Center, and Stephanie L. van der Pas from the Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, both in the Netherlands, write that the results were convincing despite the study’s limitations.
“The findings send a strong message that the burden of proof now rests on those who wish to defend the standpoint that shoulder arthroscopy is more effective than non-surgical interventions,” they write.
“Hopefully, these findings from a well respected shoulder research group will change daily practice. The costs of surgery are high, and although the low occurrence of complications might suggest that the surgery is benign, there is no indication for surgery without possible gain.”
The study was funded by Arthritis Research UK, the National Institute for Health Research Oxford Biomedical Research Centre (previously the Biomedical Research Unit), and the Royal College of Surgeons (England). The authors have disclosed no relevant financial relationships.
Lancet. Published online November 20, 2017. Article full text, Comment full text
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