TL;DR
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A randomized trial of 192 adults found that high-volume injections for midportion Achilles tendinopathy did not significantly outperform sham treatment after 12 months. Hydrocortisone-containing injections improved symptoms more at six weeks, but the difference faded by week 12 and outcomes were worse on some measures by week 26.
A randomized trial of 192 adults with midportion Achilles tendinopathy found that high-volume injections did not produce significantly better outcomes than sham injections at 12 months. The hydrocortisone-containing treatment offered greater relief at six weeks, but that advantage had disappeared by week 12, and some measures later suggested worse outcomes, according to researchers reporting in The BMJ.
Participants were assigned to one of three groups: a high-volume injection of bupivacaine and saline, the same mixture with 25 milligrams of hydrocortisone, or a sham procedure using a smaller amount of bupivacaine injected away from the tendon area expected to respond. All participants had gradual-onset pain in the middle portion of the Achilles tendon lasting at least three months, confirmed by ultrasound.
The main outcome was change in VISA-A scores, a 100-point scale measuring Achilles-related pain and disability, with lower scores indicating worse symptoms. At 52 weeks, scores had improved by roughly 25 to 30 points across all three groups, with no statistically significant difference between them. Eleven participants did not provide week-52 scores; the researchers said analyses limited to participants who completed the study produced similar findings.
The steroid group showed about a 10-point greater improvement at week six than the other groups. By week 12, that gap was no longer present. At week 26, pain and disability outcomes appeared worse for the steroid group than for sham and were significantly worse than for the bupivacaine-only group; the difference later narrowed and was not statistically significant at the end of follow-up. Bupivacaine alone did not differ from sham at any measured time, according to the report.
The Short-Term Relief Trade-Off
The findings challenge the case for routinely using these injections for midportion Achilles tendinopathy, particularly when patients and clinicians are weighing brief symptom relief against results over a longer period. The researchers concluded that the clinical data do not support routine use of high-volume injections with corticosteroid for this condition.
The result matters to people deciding whether to undergo an injection and to clinicians explaining its likely course. The trial does not show that no individual can improve after treatment: all groups improved on average. Rather, it found no significant 12-month advantage over sham, while the early advantage associated with hydrocortisone did not last. The study also reported that the steroid-containing treatment reduced overall healthcare costs during the study period, a finding that does not by itself establish better long-term value for every patient.
These results are specific to the patients, injection protocol and follow-up studied. They do not establish that every injection approach for every tendon condition has the same effects. They do, however, reinforce the need to discuss both the time-limited benefit observed here and the uncertainty about longer-term outcomes before treatment.
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How the Trial Tested Injections
High-volume injections combining saline with an anesthetic, and sometimes a corticosteroid, have been used for tendon pain despite limited rigorous evidence. One proposed approach is to inject a large volume near the Achilles tendon. Prior studies had produced mixed results, leaving uncertainty about whether improvement came from the active treatment or other factors, including the procedure itself and the natural course of symptoms.
In this trial, the two active regimens each used 10 milliliters of 0.5% bupivacaine and 40 milliliters of saline; one also included hydrocortisone. The sham group received 2 to 3 milliliters of bupivacaine at least 10 millimeters away from the tendon-fat-pad junction targeted by active injections. Researchers said the sham placement could still cause a numbing effect, helping keep participants unaware of their assignment. A sleeve concealed the temporary bulge caused by the larger-volume injections.
Participants were about 50 years old on average, and just under half were women. Their baseline VISA-A scores were approximately 50 in each group. The trial was led by Peter Malliaras of Monash University in Melbourne and reported in The BMJ, alongside an editorial discussing how to interpret the early benefit and later results.
“The clinical data do not support routine use for midportion Achilles tendinopathy.”
— Peter Malliaras and colleagues
Limits of the Current Evidence
The trial tested a particular high-volume injection protocol in adults with ultrasound-confirmed, gradual-onset midportion symptoms. Its findings should not automatically be applied to other Achilles conditions, different injection methods, or patients outside the study population. The report does not establish why the steroid group’s outcomes appeared worse at week 26, nor does it show that every patient receiving hydrocortisone will have that experience.
Although the week-26 difference between the steroid and bupivacaine-only groups was statistically significant, it was not significant at 52 weeks. The reported cost analysis favored the steroid regimen over sham during the study year, but the available source material does not provide the full cost figures or enough detail to determine how those results would apply across health systems. Further research would be needed to clarify how durable the early relief is and which patients, if any, might benefit.
How Clinicians May Apply Results
The immediate next step is clinical discussion, not a change inferred for every patient from one trial. The researchers’ findings give clinicians evidence to weigh against routine use of high-volume steroid injections for the specific condition studied. Orchard’s editorial calls for explaining that the observed early benefit was temporary and discussing possible longer-term trade-offs as part of informed consent.
The study followed participants for a year, but it does not settle every question about injection treatment or other care options. The report and source material do not announce a new guideline or a planned follow-up study. Patients considering an injection can ask their clinician what benefit is expected, how long it may last, what alternatives are appropriate for their circumstances, and what uncertainties remain.
Key Questions
Did the injections improve Achilles tendinopathy more than sham treatment?
At 12 months, the trial found no statistically significant difference between high-volume injections with or without hydrocortisone and the sham procedure. All three groups improved on average.
Did hydrocortisone provide any short-term benefit?
The hydrocortisone group showed greater improvement at six weeks, by roughly 10 VISA-A points compared with the other groups. That advantage was no longer present by week 12.
What happened to outcomes later in the study?
At week 26, outcomes in the steroid group appeared worse than sham and were significantly worse than the bupivacaine-only group. The gap narrowed afterward and was not statistically significant at 52 weeks.
Who was included in the trial?
The 192 participants were adults with gradual-onset, ultrasound-confirmed pain in the middle portion of the Achilles tendon lasting at least three months. The results may not apply to other tendon conditions or patient groups.
Does the trial rule out injections for every patient?
No. The study found no significant group-level advantage at one year for the injection approaches tested; it did not determine that no individual can benefit. Patients should discuss potential benefits, duration and uncertainties with a clinician.
Source: medpagetoday.com
