Scientists in Norway had said that saline lavage, which is meant to loosen up calcified shoulder tendons, provided no benefit in a double-blind, sham-controlled trial, the study being the latest to cast doubt on a common orthopaedic procedure.
The team found that four months after treatment, Oxford Shoulder Score (OSS) or 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, said Dr Stefan Moosmayer, 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 four 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 two and six, versus sham-plus-lidocaine-only, but not at subsequent evaluations.
MedPage Today reports that 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 said.
Similar procedures
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 programme, which, to the extent that it was therapeutic, may have helped equalise 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 Dr David Robinson and three colleagues at Harvard Medical School, “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.”
How they did it
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, three 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 three 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 randomised 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 two and six and then at months four (primary endpoint), eight, 12, and 24, after 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 four, OSS scores improved in all three groups by roughly six 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 four 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 three-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”.
Study details
Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study
Stefan Moosmayer, Hanna Björnsson Hallgren, Jens Ivar Brox, et al.
Published in The BMJ on 11 October 2023
Abstract
Objective
To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder.
Design Pragmatic
Three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months.
Participants
220 adults with calcific tendinopathy of the shoulder, persistent for at least three months.
Interventions
Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises.
Main outcome measures
The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated.
Results
Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval −2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (−0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid −1.8 (−4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported.
Conclusions
This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder.
MedPage Today article – Common Shoulder Procedure Found Worthless (Open access)