Overview

Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain

Status:
Recruiting
Trial end date:
2020-12-15
Target enrollment:
0
Participant gender:
All
Summary
Good shoulder function is a prerequisite for effective hand function, as well as for performing multiple tasks involving mobility, ambulation, and activities of daily living (ADL). A common sequela of stroke is hemiplegic shoulder pain, which can hamper functional recovery and subsequently lead to disability. Hemiplegic shoulder pain can begin as early as 2 weeks post stroke but typically occurs within 2-3 months post stroke.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Benha University
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Methylprednisolone Acetate
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.