A new study concludes that a combination of saline injection and ultrasound-guided irrigation in the treatment of shoulder calcific tendinopathy is no more effective than a placebo treatment, calling into question current treatments and calling for further treatment. The need for research and alternative approaches is emphasized.
Results from recent trials suggest that the use of this therapy should be reevaluated.
Recently published clinical trials BMJ A saline injection treatment commonly employed to treat calcific tendinopathy, a painful condition caused by calcium buildup in the rotator cuff tendons of the shoulder, has a significant It turns out that there is no advantage.
The study found that the perceived benefits of ultrasound-guided irrigation (a procedure in which calcium deposits are injected with saline to dissolve them), even when combined with steroid injections, are no greater than those gained from sham (placebo) treatment. It has been demonstrated that it is equivalent to
Researchers say the findings call into question the use of ultrasound-guided irrigation for this condition and should lead to a “significant reconsideration” of existing treatment guidelines.
Research background and methodology
Despite its widespread use, ultrasound-guided irrigation has never been compared to sham treatment, and it remains unclear whether the reported improvements are due to the treatment itself, natural recovery over time, or It is unclear whether this is due to a placebo effect.
To fill this important evidence gap, researchers from Norway and Sweden are the first to test the true effectiveness of ultrasound-guided irrigation with steroid injections in patients with shoulder calcific tendinopathy. A sham control study was conducted.
Their findings show that between April 2015 and March 2020, 218 adults (average age 50 years old, approximately 65% female).
At the beginning of the trial, patients provided information about various health and lifestyle factors, and X-rays were taken to assess the size of their calcium deposits.
Patients were then randomly divided into three treatment groups. Washing and steroid injection (73 participants), sham washing and steroid injection (74 participants), and sham only (71 participants). After treatment, all patients were asked to complete a home exercise program.
Evaluation and results
The primary measures of interest were pain intensity and functional disability on the Oxford Shoulder Score (0-48 point scale) reported by the patient at 2 weeks, 6 weeks, and 4, 8, 12, and 24 months. was.
At 4 months, there were no significant differences in pain and functional limitations between the three groups. At subsequent evaluations, scores remained similar even in patients whose calcium deposits had disappeared, which the researchers say casts doubt on the notion that lysis of periarticular calcium resolves symptoms. Says.
The steroid injection group reported better pain relief than the sham group at 2 and 6 weeks post-treatment, but of note, after 4 months the improvement was no different than the sham group. did not.
Findings and recommendations
Although the researchers acknowledge some limitations, including the lack of an untreated group to assess the natural course of symptoms, the double-blind, three-group design, including a sham group, They stated that they were able to evaluate the true clinical efficacy. Active treatment.
Therefore, they wrote, “Our results question existing recommendations for the treatment of calcific tendinopathy and may require a critical reexamination of established treatment concepts for these patients.” ” concludes.
Future studies should investigate alternative treatments, such as defined physical therapy programs, and should also include no treatment groups to assess the impact of the natural history of calcific tendinopathy on outcomes. the researchers added.
In a linked editorial, US researchers say that cleaning appears to be overused and may not be as effective as we think. However, it would be premature to conclude that ultrasound-guided irrigation or subacromial corticosteroid injections no longer have a role in the treatment of shoulder calcific tendinopathy.
These new findings should inform discussions with patients suffering from similar long-term symptom courses in which time resolves and corticosteroids may promote short-term pain relief. may provide some reassurance to the population,” the researchers added.
And they say future studies should include sham control groups, assess treatment response earlier in the course of symptoms, and investigate whether ultrasound classification systems can better predict treatment response. suggests.
Reference: “Ultrasound-guided lavage with corticosteroid injection versus sham lavage with corticosteroid injection for calcific tendinopathy of the shoulder: a randomized double-blind multi-arm study” Stefan Moosmayer, Ole Marius Ekeberg, Hanna Björnsson Hallgren, Ingar Heier, Synnove Kvalheim, Niels Gunnar Jewell, Jesper Blomquist, Hugo Ripp, Jens Ivor Brox, October 11, 2023, BMJ.
DOI: 10.1136/bmj-2023-076447
This study was funded by the Bergersen Foundation, the Aase Bye and Trygve J.B. Hoffs Foundation, Smith and Nephew, and the Medical Research Council of South East Sweden.
Source: scitechdaily.com
