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A randomized trial of 192 adults with midportion Achilles tendinopathy found no significant difference in pain and disability outcomes between high-volume injections and a sham procedure at 12 months. The hydrocortisone group improved more at six weeks, but that advantage faded and scores were worse than with bupivacaine alone at 26 weeks.
A randomized trial involving 192 adults found that high-volume injections for midportion Achilles tendinopathy did not significantly improve pain and disability more than a sham procedure after 12 months. The hydrocortisone-containing injection produced greater improvement at six weeks, but the difference did not last, and the researchers said the findings do not support routine use of the treatment.
Researchers assigned participants to one of three approaches: bupivacaine plus saline, the same injection with 25 milligrams of hydrocortisone, or a sham injection containing a smaller amount of bupivacaine and saline. The active high-volume injections contained 10 milliliters of 0.5% bupivacaine and 40 milliliters of saline. The sham was delivered at a nearby site not expected to affect tendon pain or swelling.
The trial’s primary outcome was change in the VISA-A score at week 52, a 100-point measure of Achilles-related pain and disability on which lower scores indicate worse symptoms. Average improvement was about 25 to 30 points across the groups, with no statistically significant difference between them at 12 months. Results were similar in a per-protocol analysis, although 11 participants did not have week-52 scores.
The steroid group showed roughly 10 points more improvement than the other groups at six weeks. By week 12, that advantage had disappeared. 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 later narrowed and was not statistically significant at the final assessment. The study also reported lower overall healthcare costs for the steroid-containing regimen compared with sham, but the supplied report does not give the amount of the difference.
The Trade-Off Between Early Relief and Later Outcomes
The findings matter to patients and clinicians weighing an injection that may offer short-term symptom relief against uncertain or less favorable later outcomes. In this trial, the early improvement associated with hydrocortisone did not translate into a measurable advantage at one year. At the 26-week check, outcomes in the steroid group were worse than with bupivacaine alone on the reported comparison.
The authors, led by Peter Malliaras of Monash University, concluded that the clinical data do not support routine use of high-volume corticosteroid injections for midportion Achilles tendinopathy. That conclusion concerns the treatment tested and the patient group studied; it does not establish that every injection approach or every patient will have the same result. The cost finding also complicates the picture: lower study-period healthcare costs do not change the lack of a significant 12-month clinical advantage.
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How the Trial Tested Achilles Injections
The study enrolled adults with gradual-onset, midportion Achilles tendinopathy lasting at least three months. The diagnosis was confirmed with ultrasound, and the participants’ average starting VISA-A score was about 50. Their mean age was about 50, and just under half were women, according to the report.
High-volume saline injections have been used for tendon problems, sometimes alongside local anesthetic or corticosteroids, although their effectiveness compared with placebo has remained uncertain. In the trial, participants were blinded to their allocation: sham injections were placed away from the tendon junction, and a sleeve covered the area so patients receiving high-volume injections could not see the temporary bulge. The researchers said the sham still produced a numbing effect to help preserve blinding.
“The clinical data do not support routine use for midportion Achilles tendinopathy.”
— Peter Malliaras and colleagues, as reported in The BMJ
Limits of the Results and Cost Data
The reported findings do not establish how the injections compare with every other treatment for Achilles tendinopathy, or whether particular patient subgroups might respond differently. The trial focused on adults with chronic, gradual-onset midportion symptoms, so the results should not automatically be applied to other tendon conditions or forms of Achilles injury.
The supplied report says the steroid regimen reduced healthcare costs over the study period, but it does not provide the cost difference or detailed economic assumptions. It also does not provide enough information to determine why the steroid group’s relative outcomes shifted between six and 26 weeks. The 12-month result was not statistically significant, and 11 participants lacked scores at that time point.
How Clinicians May Use the Evidence
The immediate implication from the trial authors is that high-volume corticosteroid injections should not be treated as a routine option for midportion Achilles tendinopathy on the basis of these data. Orchard’s editorial called for clinicians who recommend or perform steroid injections to explain that any early benefit may be temporary and to discuss the potential longer-term trade-off as part of informed consent.
The study followed participants for one year, and the supplied report does not identify a planned follow-up study or a change to clinical guidelines. Further research would be needed to clarify which patients, if any, benefit from this approach and how its costs compare with other care. For now, the trial’s main finding is that the injection regimens tested did not produce a significant 12-month advantage over sham.
Key Questions
Did the injections improve Achilles tendinopathy more than sham treatment?
At 12 months, the trial found no statistically significant difference in pain and disability improvement between the injection groups and sham.
Did hydrocortisone have any effect?
The hydrocortisone group showed about 10 points more improvement at six weeks, but the advantage had disappeared by week 12. At week 26, outcomes were significantly worse than with bupivacaine alone.
Who took part in the trial?
The 192 participants were adults with ultrasound-confirmed, gradual-onset midportion Achilles tendinopathy lasting at least three months.
What did the researchers conclude?
The researchers said the clinical findings do not support routine use of high-volume corticosteroid injections for midportion Achilles tendinopathy.
Source: medpagetoday.com
