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A randomized trial of 192 adults found that high-volume injections for midportion Achilles tendinopathy did not significantly improve outcomes over a sham injection at 12 months. Hydrocortisone added short-term relief at six weeks, but that benefit faded and pain and disability scores were worse at week 26 than with bupivacaine alone.
A randomized trial involving 192 adults found that high-volume injections did not provide a significant advantage over sham treatment for midportion Achilles tendinopathy after 12 months. The hydrocortisone-containing injection improved symptoms more at six weeks, but that difference had disappeared by week 12, and the researchers said outcomes later raised concern about longer-term effects.
The trial, reported in The BMJ by Peter Malliaras of Monash University in Melbourne and colleagues, assigned patients to one of three groups: bupivacaine and saline, the same mixture with 25 milligrams of hydrocortisone, or a sham injection. The active high-volume injections contained 10 milliliters of 0.5% bupivacaine and 40 milliliters of saline. The sham used a smaller amount of bupivacaine and was delivered away from the tendon area expected to affect symptoms.
Participants were adults with gradual-onset pain in the middle portion of the Achilles tendon lasting at least three months. Ultrasound was used to confirm the condition. The researchers measured pain and disability with the VISA-A score, a 100-point scale on which lower scores indicate more severe symptoms. At the start, average scores were about 50 in each group.
At 52 weeks, average score improvements were 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 report said analyses limited to participants who completed the protocol produced similar results. Bupivacaine alone also showed no significant advantage over sham at any measured time.
What the Results Mean for Injections
The results challenge the use of high-volume injections as a routine treatment for this form of Achilles tendinopathy. The approach has been used in clinical practice despite limited and mixed evidence, and the trial found that improvements over a year were similar to those after the sham procedure. That does not mean every patient will have the same experience, but it weakens the case for expecting a durable benefit from the injection itself.
The steroid results point to a possible trade-off rather than a lasting solution. The hydrocortisone group had significantly greater improvement at six weeks, by about 10 VISA-A points compared with the other groups. By week 26, however, scores in that group were worse than with bupivacaine alone, and the gap was statistically significant in that comparison. The difference later narrowed and was no longer significant at the final assessment. The pattern matters to patients weighing short-term symptom relief against longer-term outcomes.
The study also reported that the steroid-containing regimen reduced overall healthcare costs during the study period compared with sham. That economic finding does not establish that the treatment is clinically superior: the primary clinical comparison at 12 months showed no significant benefit. Cost-effectiveness estimates and patient outcomes answer different questions, and the source report does not provide enough detail here to treat the cost result as a reason to recommend injections.
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How the Trial Tested Tendon Injections
High-volume injections for Achilles tendinopathy use a large volume of saline, sometimes alongside a local anesthetic and corticosteroid. The proposed approach has gained attention in a field where some orthopedic procedures became common before strong trial evidence was available. Earlier studies of high-volume injections produced mixed findings, according to the report, leaving uncertainty about whether any improvement came from the injection, its ingredients, or other factors.
In this study, active injections were placed near the junction of the Achilles tendon and Kager’s fat pad. Sham injections were delivered at least 10 millimeters away from that junction, at a site not expected to provide therapeutic benefit. The researchers used a sleeve over the area so participants would not see the temporary bulge associated with the high-volume treatment. The sham still included a small amount of bupivacaine to produce a numbing effect and help maintain blinding.
Participants were about 50 years old on average, and slightly fewer than half were women. The primary outcome was the change in VISA-A score at 52 weeks. The report says the trial’s findings support the researchers’ conclusion that the clinical data do not support routine use of these injections for midportion Achilles tendinopathy.
“The clinical data do not support routine use for midportion Achilles tendinopathy.”
— Peter Malliaras and colleagues
Limits of the Long-Term Evidence
The trial does not establish why the three groups improved by similar amounts over the year, nor does the information provided identify which factors accounted for those gains. It also cannot show that every patient with Achilles tendon pain will respond in the same way. The findings apply to the studied group: adults with gradual-onset, ultrasound-confirmed midportion tendinopathy lasting at least three months.
The week-26 worsening in the steroid group was statistically significant compared with bupivacaine alone, but the difference was no longer significant at 12 months. The report describes this as a concern about longer-term outcomes, not proof that hydrocortisone causes lasting harm. The size and clinical importance of the observed differences, and whether the pattern applies to other steroid doses or injection methods, remain uncertain based on the supplied results.
The reported healthcare-cost advantage for the steroid regimen also needs to be read alongside the clinical findings. The available report does not provide the full cost analysis, its assumptions, or enough detail to independently judge how robust that estimate is. It remains unclear whether the same cost result would hold in other health systems or over a different period.
How Clinicians May Use the Findings
The trial report gives clinicians and patients evidence to discuss when considering high-volume injections for midportion Achilles tendinopathy. Malliaras and colleagues say the clinical data do not support routine use; Orchard’s editorial calls for the short-term benefit and potential longer-term trade-off to be explained as part of informed consent. The study does not set out a replacement treatment plan, so it should not be read as a comparison of all available care options.
Further research would be needed to clarify which patients, if any, might gain a meaningful short-term benefit and whether changes in injection ingredients or technique alter outcomes. For now, the central result is the absence of a significant 12-month advantage over sham, alongside a temporary improvement in the steroid group that faded. The source material does not report a planned follow-up study or a policy change.
Key Questions
Did the injections work better than sham at 12 months?
No. The trial found no statistically significant difference in VISA-A score improvement between the three groups at 52 weeks.
Did hydrocortisone help at all?
The hydrocortisone group had significantly greater improvement at six weeks, by roughly 10 VISA-A points compared with the other groups. The advantage was gone by week 12.
What happened to outcomes later in the study?
At week 26, pain and disability scores in the steroid group were worse than in the bupivacaine-only group, with a statistically significant difference in that comparison. The gap narrowed and was not statistically significant at 12 months.
Who took part in the trial?
The 192 participants were adults with gradual-onset, ultrasound-confirmed midportion Achilles tendinopathy and symptoms lasting at least three months.
Does the study prove steroid injections cause long-term harm?
No. The trial found a concerning pattern at week 26 in one comparison, but that difference was no longer statistically significant at 12 months. The reported results do not prove lasting harm or establish how the findings apply to other injection methods.
Source: medpagetoday.com
