Hemiplegic shoulder pain
Conditions
Interventions
Experimental group:Botulimum Toxin A+Exercise therapy and modality
control group:Constituents of Botox solvent+ Exercise therapy and modality
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years male and female; 2. Having spastic hemiparesis due to CVA of 2 or more months of evolution; 3. Moderate-severe spastic shoulder pain: Visual Analogue Scale (VAS) for pain equal to or greater than 40 mm; 4. Spasticity of 1+ or more points as determined by the Modified Ashworth Scale (MAS) for the external rotation and abduction; 5. Limited range of passive motion of the shoulder: external rotation and abduction 10 to 30 degree related to the opposite side; 6. Be able to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
Exclusion criteria
Exclusion criteria: 1. The BoNT-A injection into the affected shoulder during the previous 6 months; 2. The presence of an other obvious explanation for the pain(eg, fracture, radiculopathy); 3. Prior surgery to either the shoulder or neck region; 4. Patient immobility involving confinement to bed for >50% of daytime hours; 5. Any medical condition that might increase the risk to the subject with exposure to BoNT-A (eg,diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function); 6. A known allergy or sensitivity to any component of the BoNT-A; 7. The presence of an unstable medical condition or a known uncontrolled systemic disease; 8. Concurrent participation in another drug or device study or participation in such a study during the 30 days before enrollment; 9. The use of aminoglycoside antibiotics, curare-like agents, or any other agent that might interfere with neuromuscular function; 10. Any condition or situation that might place the subject at significant risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS for pain assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Spasticity of the hemiplegic shoulder abduction and external rotation measured with the MAS;Pain-free range of motion of the hemiplegic shoulder abduction and external rotation expressed in degrees, and the passive ROM of hemiplegic shoulder using goniometry; | — |
Countries
China
Contacts
Public ContactLang Jia
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed