Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062615) titled 'Effectiveness of radial extracorporeal shockwave therapy (rESWT) for shoulder pain in patients with stroke' on Aug. 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Morinomiya hospital

Condition: Condition - Post-stroke shoulder pain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effectiveness of radial extracorporeal shockwave therapy (rESWT) for shoulder pain in patients with stroke. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Radial extracorporeal shockwave therapy (rESWT) will be applied to the affected shoulder for 2 weeks, twice weekly, for a total of 4 sessions. Each session will consist of 6,000 shocks at a pressure of 2 bar and a frequency of 15 Hz. After the initial 2-week intervention period, no further rESWT will be administered, and the participants will be followed during the subsequent observation period. Interventions/Control_2 - Sham radial extracorporeal shockwave therapy (sham rESWT) will be applied to the affected shoulder for 2 weeks, twice weekly, for a total of 4 sessions. The sham treatment will follow the same treatment procedures and treatment duration as the rESWT group but will use a sham stimulus that does not deliver therapeutic shockwave energy. After the initial 2-week sham intervention period, participants will receive open-label rESWT during the subsequent intervention period.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Individuals with hemiparesis resulting from stroke (cerebral infarction or intracerebral hemorrhage) 2. Individuals with pain localized to the affected shoulder joint Key exclusion criteria - 1. Individuals who have difficulty understanding the study procedures due to higher brain dysfunction (attention, memory, apraxia, aphasia, or unilateral spatial neglect) or cognitive impairment 2. Individuals whose dosage of analgesic medication may be changed during the study period 3. Individuals who are receiving intra-articular injections or are likely to receive such injections during the study period 4. Individuals receiving anticoagulant therapy with an international normalized ratio (INR) >4.0 5. Individuals with shoulder pain that was present before the onset of stroke 6. Individuals who meet the diagnostic criteria for complex regional pain syndrome (CRPS) 7. Individuals with allodynia 8. Individuals with causes of shoulder pain other than hemiplegic shoulder pain (HSP) 9. Individuals whom the attending physician considers unsuitable for participation in the study Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 24 Day Date of IRB - 2025 Year 11 Month 26 Day Anticipated trial start date - 2026 Year 08 Month 24 Day Last follow-up date - 2029 Year 08 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071659

Disclaimer: Curated by HT Syndication.