stroke
Conditions
Interventions
intervention group:BoNT-A 100U (2ml) was injected into subscapular muscle and pectoralis major muscle respectively, with a total of 200U (4ml).
Positive control group:BoNT-A 100U (2ml) was injected into the subscapular muscle and normal saline(2ml) was injected into the pectoralis major muscle.
Negative control group (placebo):Normal saline(2ml) was injected into subscapular muscle and pectoralis major muscle respectively, with a total of 4ml.
Sponsors
Wenzhou TCM Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Over the age of 18, both men and women can. 2. Spastic hemiplegia caused by stroke (infarction / hemorrhage). 3. Shoulder pain after moderate to severe hemiplegia, visual analog score (VAS) = 4 cm. 4. Modified Ashworth scale (MAS) score = 1 for shoulder abduction or circumflex muscle spasm on the affected side. 5. The painless passive range of motion of the affected shoulder is limited, which means that the range of passive abduction or external rotation in the painless range is at least 10 degrees less than that of the opposite side. 6. Be able to understand and agree to the test procedure and sign an informed consent form in accordance with national laws and regulations.
Exclusion criteria
Exclusion criteria: 1. BoNT-A has been injected into the affected shoulder in the first 6 months. 2. Previous traumatic or neurological diseases lead to shoulder paralysis on the affected side. 3. There are other obvious causes of pain (such as fractures, radiculopathy). 4. Have had surgery on the shoulder or neck. 5. Any medical condition that may increase the subject's risk of exposure to BoNT-A (for example, diagnosed myasthenia gravis, Lambert-Eaten syndrome, amyotrophic lateral sclerosis or any disease that may interfere with neuromuscular function). 6. Known to be allergic or sensitive to any ingredient of BoNT-A. 7. The existence of unstable medical conditions or uncontrolled known systemic diseases. 8. At the same time, participate in other drug or equipment studies or participate in such studies within 30 days before joining the group. 9. Use aminoglycoside antibiotics or any drug that may interfere with neuromuscular function. 10. Patients who are unable to cooperate with injection therapy due to severe cognitive impairment or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum passive range of motion of shoulder joint under painless condition;Modified Asworth muscle tone score;Fugl-Meyer upper limb function rating scale;SF-36(Quality of life scale); | — |
Countries
China
Contacts
Public ContactLulu Pan
Wenzhou TCM Hospital of Zhejiang Chinese Medical University
Outcome results
None listed