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In a randomized trial of 192 adults with midportion Achilles tendinopathy, high-volume injections did not improve pain and disability more than sham treatment at 12 months. Hydrocortisone added to the injection was linked to greater improvement at six weeks, but that advantage faded and outcomes appeared worse at week 26 before the difference was no longer statistically significant later.
A three-arm randomized trial involving 192 adults found that high-volume injections for midportion Achilles tendinopathy did not improve pain and disability more than sham injections after 12 months, according to results reported in The BMJ. An injection containing hydrocortisone provided a short-term advantage at six weeks, but that difference had disappeared by week 12, and the study authors said the findings do not support routine use of the treatment.
Participants were assigned to one of three treatments: bupivacaine and saline with 25 milligrams of hydrocortisone; bupivacaine and saline without the steroid; or a sham injection of a smaller amount of bupivacaine placed away from the tendon area expected to affect symptoms. The two high-volume treatments used 10 milliliters of 0.5% bupivacaine and 40 milliliters of saline. The sham procedure was designed to preserve blinding, including a numbing effect from the anesthetic.
The trial’s primary outcome was change in VISA-A scores at week 52. The scale measures Achilles-related pain and disability from 0 to 100, with lower scores indicating worse symptoms. Average improvement was about 25 to 30 points in each group, and differences between groups at 12 months were not statistically significant. Eleven participants did not provide week-52 scores; the researchers said analyses limited to participants who completed the protocol produced similar results.
The hydrocortisone group improved more than the other groups at six weeks, by roughly 10 VISA-A points. That advantage was no longer present by week 12. At week 26, scores in the steroid group were numerically worse than in the sham group and significantly worse than in the bupivacaine-only group; the gap narrowed later and was not statistically significant by the end of follow-up. No differences between bupivacaine alone and sham were reported at any time.
What the Results Mean for Injections
The findings put a commonly used procedure under scrutiny: patients may receive a short-lived improvement from a steroid-containing injection without a demonstrated advantage over sham at one year. The week-26 result also raises concern that the early improvement may come with a later downside, although the study does not establish why that pattern occurred or show a statistically significant difference at 12 months.
For patients weighing treatment options, the results make the timing of expected benefit relevant. A temporary reduction in symptoms may matter to some people, but it is not equivalent to lasting improvement. The investigators reported that the steroid-containing regimen reduced healthcare costs over the study period, but that economic finding does not change the lack of a significant 12-month clinical advantage. Decisions about injections should account for the uncertain longer-term trade-off and be discussed with a clinician.
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How the Trial Tested the Procedure
The study enrolled adults with gradual-onset, midportion Achilles tendinopathy confirmed by ultrasound, with symptoms lasting at least three months. The condition commonly affects people who run or take part in other activities. Participants had an average age of about 50, and their baseline VISA-A scores averaged around 50 across the groups.
High-volume saline injections have been used as a treatment approach, while corticosteroid use for tendon problems has been debated because of reports of possible longer-term harms in other conditions, including tennis elbow. The trial authors, led by Peter Malliaras of Monash University in Melbourne, compared injections placed near the tendon with a sham procedure delivered at least 10 millimeters away from the tendon-fat-pad junction. Their report in The BMJ adds randomized evidence to earlier studies that had not established a clear benefit over placebo.
“The clinical data do not support routine use for midportion Achilles tendinopathy.”
— Peter Malliaras and colleagues, the trial authors
Limits of the Long-Term Findings
The trial found no significant difference between groups at 12 months, but that does not prove the treatments are identical for every patient. The week-26 pattern in the hydrocortisone group was a concern in the reported results, yet the reason for it is not established, and the later difference was not statistically significant. The report also does not establish whether other patient groups, injection protocols, or treatment combinations would produce different results.
The source material does not provide the full cost estimates or the size of the cost difference, so the reported economic advantage cannot be quantified here. It is also unclear from the available details how the results compare across specific patient subgroups or whether the short-term changes translated into differences in activity or return to sport.
How Clinicians May Use the Evidence
The trial report provides evidence for clinicians and patients to discuss when considering injections for midportion Achilles tendinopathy. The authors’ stated conclusion is that the data do not support routine use. The accompanying editorial calls for clinicians recommending or performing corticosteroid injections to explain the possible short-term benefit and the longer-term uncertainty as part of informed consent.
No further trial milestone or follow-up study is specified in the available report. For now, the key evidence is the comparison through 12 months: similar average improvement across all three groups, with a temporary early advantage and a concerning, later but ultimately non-significant pattern in the steroid group.
Key Questions
Did the injections work better than sham after a year?
No. The trial reported no statistically significant difference at 12 months in VISA-A score changes among the hydrocortisone, bupivacaine-only, and sham groups.
Did hydrocortisone provide any benefit?
The hydrocortisone group showed greater improvement at six weeks, by roughly 10 VISA-A points, but the advantage had disappeared by week 12. The result does not show a lasting benefit at one year.
What happened to the steroid group’s scores later?
At week 26, outcomes in the steroid group appeared worse than in the sham group and were significantly worse than in the bupivacaine-only group. The gap narrowed afterward and was not statistically significant at 12 months.
Who was included in the trial?
The study enrolled 192 adults with gradual-onset, ultrasound-confirmed midportion Achilles tendinopathy lasting at least three months. The average participant was about 50 years old.
Does the study rule out injections for every patient?
No. The authors said the findings do not support routine use for midportion Achilles tendinopathy, but the results do not establish that every individual will respond the same way. Patients should discuss treatment choices and possible trade-offs with a clinician.
Source: medpagetoday.com
