Efficacy and Tolerability of Peritendinous Hyaluronic Acid in Patients with Supraspinatus Tendinopathy: a Multicenter, Randomized, Controlled Trial

Abstract

Background: Physical therapy and peritendinous hyaluronic acid (HA) injections have both shown promising results in the treatment of shoulder tendinopathies. However, the superiority of treatment combining physical therapy and HA is unclear.

Methods: Patients with ultrasound-confirmed supraspinatus tendinopathy were randomized to receive either physical therapy + subacromial HA injections or physical therapy only. Treatment efficacy was assessed using a Visual Analog Scale (VAS) for pain and an Activities of Daily Living (ADL) scale. Other measures were the number of rehabilitation sessions and days needed for recovery, the Tampa Scale for Kinesiophobia (TSK), and the physician and patient's perception of efficacy and tolerability. Patients were followed up for 90 days.

Results: Overall, VAS and ADL scores showed a progressive decrease during the follow-up (P < 0.01 at all visits for both groups), without significant differences between groups. The TSK score decreased significantly more in the HA group than in the control group (3.6 vs. 2.4; P < 0.001). Patients in the control group needed more rehabilitation sessions (28 vs. 22 in the HA group; P = 0.006) and more days for returning to their pre-injury activity (32 vs. 20 in the HA group; P = 0.013). Both patients and investigators perceived higher efficacy in the HA group than in the control group (P = 0.034). Both treatments were safe and well tolerated.

Conclusions: Subacromial HA injections combined with physical therapy have high efficacy in the treatment of supraspinatus tendinopathy, leading to an earlier return to pre-injury activity and the need for fewer rehabilitation sessions, which may benefit both patients and the healthcare system.

Fig. 1

Flow diagram of the patients included in the study

Fig. 2

Main efficacy outcomes. ASES American Shoulder and Elbow Surgeons standardized shoulder assessment form: ADL Activities of Daily Living domain (a), VAS Visual Analogue Scale domain (b). Number of rehabilitation sessions needed for recovery (c). Tampa Scale for Kinesophobia (d). **p < 0.01 for control vs. HA groups comparison. ***p < 0.001 for control vs. HA groups comparison

Fig. 3

Perceived efficacy (a, b) and tolerability (c, d) outcomes, assessed on a 4-point Likert scale. *p < 0.05 for control vs. HA groups comparison. **p < 0.01 for control vs. HA groups comparison. ***p < 0.001 for control vs. HA groups comparison