Radial extracorporeal shock wave therapy for the management of spasticity in cerebral palsy: a randomized controlled trial with different time intervals between sessions.

Background: Spasticity is the most frequent motor disorder in cerebral palsy (CP). Radial extracorporeal shock wave therapy (rESWT) has emerged as an effective, non-invasive, and well-tolerated alternative for the management of clinical manifestations of spasticity in patients with CP. Despite the variability in administration protocols, no study has evaluated whether extending the time interval between sessions allows prolongation of the therapeutic benefit on these clinical manifestations. Methods: Participants were randomly assigned to three groups. The control group received three rESWT sessions with a one-week interval between sessions, experimental group 1 received three rESWT sessions with a two-week interval between sessions, and experimental group 2 received three rESWT sessions with a four-week interval between sessions. The primary outcome was the between-group difference in changes in stretch angles of the soleus and gastrocnemius muscles, assessed using the Modified Tardieu Scale. Secondary outcomes were the functional response in overall mobility assessed with the Timed Up and Go Test and improvement in gait assessed with the 10-Meter Walk Test. Outcomes were assessed in all study groups immediately before the first rESWT session and at 3, 5, 9, 12, and 24 weeks from the start of treatment. Results: Seventy-one patients completed the intervention. In all groups, a significant improvement in passive range of motion and in the catch angle of the triceps surae muscle was observed between baseline and the end of follow-up ( Discussion: Although no significant differences were observed between treatment groups and increasing the time interval between sessions was not associated with a prolongation of the therapeutic effect, all groups showed a statistically significant improvement compared with baseline. Conclusion: These results suggest that, from a clinical perspective, rESWT application may allow a degree of flexibility, enabling adjustment of the intersession interval according to clinical needs and patient availability without compromising the observed therapeutic effects. Clinical trial registration: ClinicalTrials.gov, Identifier: NCT05702606.