Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial

Abstract

Importance: Corticosteroid injections and exercise therapy are commonly used to treat chronic midportion Achilles tendinopathy, but the evidence for this combination is limited.

Objective: To investigate the effect of corticosteroid injection and exercise therapy compared with placebo injection and exercise therapy for patients with Achilles tendinopathy.

Design, setting, and participants: This was a participant-blinded, physician-blinded, and assessor-blinded randomized clinical trial of patients with Achilles tendinopathy verified by ultrasonography. Assessment of pain and function were conducted at baseline and at 1, 2, 3, 6, 12, and 24 months. Patients were recruited from a university medical clinic and a private rheumatology clinic in Denmark between April 2016 and September 2018. Data analysis was performed from June to September 2021.

Interventions: Corticosteroid injection and placebo injection were performed with ultrasonography guidance. Exercise therapy was based on previous trials and consisted of 3 exercises done every second day.

Main outcomes and measures: The primary outcome was the Victorian Institute of Sports Assessment-Achilles (VISA-A) score (range, 1-100, with 100 representing no symptoms) at 6 months. Secondary outcomes included pain measured using a 100-mm Visual Analog Scale for morning pain and pain during exercise (with higher scores indicating worse pain), global assessment (Likert scale), and tendon thickness.

Results: A total of 100 patients were included, with 52 randomized to placebo (mean age, 46 years [95% CI, 44-48 years]; 32 men [62%]) and 48 randomized to corticosteroid injection (mean age, 47 years [95% CI, 45-49 years]; 28 men [58%]). Patients in the 2 groups had similar height (mean [SD], 177 [8] cm), weight (mean [SD], 79 [12] kg), and VISA-A score (mean [SD], 46 [18]) at baseline. The group receiving exercise therapy combined with corticosteroid injections had a 17.7-point (95% CI, 8.4-27.0 points; P < .001) larger improvement in VISA-A score compared with patients receiving exercise therapy combined with placebo injections at 6 months. No severe adverse events were observed in either group, and there was no deterioration in the long term (2-year follow-up).

Conclusions and relevance: Corticosteroid injections combined with exercise therapy were associated with better outcomes in the treatment of Achilles tendinopathy compared with placebo injections and exercise therapy. A combination of exercise therapy and corticosteroid injection should be considered in the management of long-standing Achilles tendinopathy.

Trial registration: ClinicalTrials.gov Identifier: NCT02580630.

Figure 1.. Participant Flow Diagram

GCS indicates glucocorticosteroid; RCT, randomized clinical trial.

Figure 2.. Primary Outcome

The figure illustrates the primary outcome, improvement in Victorian Institute of Sports Assessment–Achilles (VISA-A) score from baseline to 6 months and the secondary outcomes of the VISA-A score at other time points (1, 2, 3, 12, and 24 months). Error bars indicate the 95% CIs. Compared with the placebo group, the group randomized to corticosteroid injection and exercise therapy had a 17.7-point (95% CI, 8.4-27.0 points; P < .001) larger improvement in VISA-A score from baseline to 6-month follow-up. The group receiving corticosteroid injection had a significantly larger improvement vs the placebo group across all time points except the 12-month follow-up (all P < .001).

Figure 3.. Tendon Thickness

The figure illustrates the ultrasonography-measured thickness of the Achilles tendon. Error bars indicate the 95% CI. Thickness of the Achilles tendon improved significantly more in the corticosteroid group compared with the placebo group at 1 month (mean difference, 1.9 mm; 95% CI, 1.1-2.6 mm; P < .001), at 2 months (mean difference, 2.2 mm; 95% CI, 1.4-3.0 mm; P < .001), at 3 months (mean difference, 2.2 mm; 95% CI, 1.5-3.0 mm; P < .001), and at 6 months (mean difference, 1.0 mm; 95% CI, 0.1-1.9 mm; P = .02).