Common Shoulder Procedure Found Worthless

— No advantage over sham in randomized controlled trial

by
John Gever, Contributing Writer, MedPage Today
October 11, 2023

Saline lavage, meant to loosen up calcified shoulder tendons, provided no benefit in a double-blind, sham-controlled trial, researchers said.

Four months after treatment, Oxford Shoulder Score (OSS) values were about the same whether patients with so-called calcific tendinopathy received the actual saline lavage plus injections with a corticosteroid (triamcinolone) and lidocaine, sham lavage plus the steroid and lidocaine, or sham lavage with the lidocaine but no steroid, according to Stefan Moosmayer, MD, PhD, of Martina Hansens Hospital in Gjettum, Norway, and colleagues.

Most secondary outcomes, including patient-reported pain and function, were also similar when participants were evaluated at 4 months and beyond, the group reported in The BMJ. The only aspect of active treatment that seemed to show a benefit was the steroid injection, and that was short-lived: patients in the two groups receiving triamcinolone reported less pain at weeks 2 and 6, versus sham-plus-lidocaine-only, but not at subsequent evaluations.

Calcific tendinopathy results from deposits of calcium hydroxyapatite accumulating within shoulder joint tendons. Ultrasound-guided saline lavage is meant to dissolve and flush them away. “Several cohort studies have reported good results with the technique, but studies with an adequate control group are lacking,” Moosmayer and colleagues explained.

Theirs is just the latest rigorous study to cast doubt on a common orthopedic procedure. Many of these, such as hyaluronic acid injections for knee osteoarthritis and spinal manipulation for lower back pain, have a wealth of anecdotal and observational evidence backing them up — but when tested in sham-controlled trials, the benefits have appeared more uncertain. Increasingly it seems that many such therapies rely primarily on the placebo effect for benefit (which, it must be said, still represents clinical relief for the patient).

With the current study, it’s important to note that all participants were also instructed to follow a home exercise program, which, to the extent that it was therapeutic, may have helped equalize outcomes. The use of lidocaine as the “sham” treatment might also raise questions as to whether it was more active than a placebo should be. (Such questions followed a landmark 2009 trial of vertebroplasty for osteoporotic compression fractures, which found no benefit when compared with lidocaine injections meant to serve as a sham.)

Authors of an editorial accompanying the shoulder lavage trial, noting a number of limitations in the study, cautioned that it would be “premature” to conclude “that ultrasound guided lavage or subacromial corticosteroid injection no longer has a role in treating calcific tendinopathy of the shoulder.”

Rather, wrote David M. Robinson, MD, and three colleagues at Harvard Medical School in Boston, “these new findings inform discussions with patients and provide some reassurance to those with a similar, long symptomatic course that time will help and corticosteroids may facilitate short term pain relief. Lavage seems to be overused and may not be as effective as we thought, and better patient selection criteria are needed.”

Study Details

Moosmayer and colleagues enrolled 220 patients seen at six hospitals in Norway and Sweden for calcific tendinopathy. Eligibility criteria included an age of at least 30, 3 or more months of shoulder pain, x-rays and ultrasonography that confirmed calcific deposits, and positive tests for impingement. Patients with other conditions or deformities that might cause shoulder pain were excluded, as were those for whom triamcinolone or lidocaine were contraindicated.

About two-thirds of patients were women, and mean age was 50. Symptom duration averaged a bit less than 3 years. Most had received some type of therapy already, such as painkillers and physiotherapy and/or steroid injections. Prior surgery was an exclusion criterion. OSS scores at baseline averaged about 30.

Participants were randomized 1:1 among the three treatment regimens:

• Active saline lavage plus subacromial injection with 20-mg triamcinolone acetonide and 9 mL of 1% lidocaine hydrochloride
• Sham lavage (the lavage procedure was mimicked for 5 minutes but without saline flushing) plus the same doses of triamcinolone and lidocaine as in the first group
• Sham lavage plus subacromial injection of 10 mL of lidocaine, no triamcinolone

Participants were evaluated at weeks 2 and 6 and then at months 4 (primary endpoint), 8, 12, and 24 following the assigned procedures. Those with unacceptable lingering pain could receive additional treatments, including repeat lavage, steroid injections, or surgery, as decided between patient and the treating physician. About two-thirds of patients in each group did, in fact, require further treatment.

At month 4, OSS scores improved in all three groups by roughly 6 points, with no significant differences. Further improvements of several points were seen in later evaluations, also with no notable between-group differences.

Similar patterns were seen for secondary measures including a shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, as well as patient-assessed pain. The most noteworthy exception was, as noted above, the groups receiving steroids reported more pain relief in the first few weeks than the sham-plus-lidocaine group.

Longer-term outcomes were similar between patients who required additional therapies after their initial assigned procedures and those who did not. Moosmayer and colleagues said this was “not surprising, because secondary treatment measures mainly consisted of the same interventions (lavage, steroid injection, physiotherapy alone or combined) that were found to be ineffective at 4 months in this study.”

This finding, they added, may reflect the “natural course of the condition,” which is not always progressive and, in many cases, resolves on its own as calcium deposits are resorbed.

Robinson and colleagues pointed to participants’ nearly 3-year average symptom duration as a potentially important limitation. In patients dealing with the condition for that long, previous studies have suggested “increasingly higher odds … of treatment failure for each additional month of symptoms,” they wrote. As a result, the current study’s sample “may represent a group with particularly recalcitrant symptoms, and outcomes might have been different had lavage been done earlier.”