Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT04467450
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of hemiparesis caused by stroke diagnosed according to World Health Organization (WHO, 2001),
2. Shoulder pain for more than 3 months.
3. pain score \>3 on a pain visual analog scale at rest.
4. pain score \>5 on a pain visual analog scale during activity.
5. pain was not relieved by conventional treatment (common analgesics, and non-steroidal anti-inflammatory drugs, slings or physical modalities).
6. No significant spasticity in the upper shoulder joint, defined as Modified Ashworth Scale (MAS) score ≤2
7. Ultrasonographically diagnosed subacromial subdeltoid (SASD ) bursitis.
Exclusion Criteria :
1. history of shoulder pain or limited ROM before stroke.
2. previous trauma history affecting shoulder
3. shoulder subluxation
4. shoulder diseases ( osteoarthritis , rheumatoid arthritis , others )
5. other neurologic diseases
6. resistance greater than a MAS score 2
7. previous shoulder botulinum toxin or steroid injection in the affected side or known allergy for botulinum toxin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04467450
Study Brief:
Protocol Section:
NCT04467450