obsteric brachial plexus palsy
Conditions
Interventions
experimental group:botulinum toxin injection of teres major and subscapularis in addition to physical therapy
controlled group:physical therapy only
Sponsors
Renhe Hospital, Baoshan Branch of North Huashan Hospital, Shanghai
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. subjects diagnosed with obsteric brachial plexus palsy; 2. aged 2 to 6 years; 3. present with internal rotation contracture and limited active abduction of shoulder for at least 2 years after birth; 4. Modified Mallet Classification of shoulder abduction rated between 2-4; 5. decreased spinohumeral abduction angle during shoulder abduction; 6. body weight more than 10Kg; 7. EKG showed QTc<450ms; 8. compliance with physical therapy and keep up with the frequency, type and intensity required by the study protocol; 9. the legal guardian should know well about the aim of the study and is willing to obey and fulfill all the follow-ups of the study; 10. the legal guardian (usually the parents) has agreed with and signed the informed consent of this study.
Exclusion criteria
Exclusion criteria: 1. previous botulinum toxin injection or orthopedic surgery (e.g. muscle transfer or cutoff) on the affected arm, 2. previous trauma,fracture or nerve injury on either side of the arm; 3. concurrent central nervous system disease or injury; 4. infection or skin disease on the injection site; 5. in any situation which increase the risk of botulinum toxin injection,including myasthenia gravis, Eaton-Lambert syndrome,or other diseases interferring the nerve-muscle function; 6. concurrent use of aminoglycoside antibiotics or other medications interferring the nerve-muscle function; 7. concurrent severe cardiac,pulmonary, hepatic or renal diseases which may increase the risk,or affect the study result or disturb the study; 8. involved in other clincial study or has took part in other study in 30 days before enrollment of this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| difference of active ROM of shoulder abduction compared with baseline;proportion of effective treatment;difference of active ROM of shoulder external rotation compared with baseline;difference of spinohumeral abduction angle compared with baseline;difference of modified Mallet classificaiton compared with baseline;difference of muscle power of shoulder abduction and external rotation compared with baseline;general assessment by parents;surface EMG data of deltoid and teres major during active shoulder abduction; | — |
Primary
| Measure | Time frame |
|---|---|
| difference of active ROM of shoulder abduction compared with baseline; | — |
Countries
China
Contacts
Public ContactHongqing Lu
Renhe Hospital, Baoshan Branch of North Huashan Hospital, Shanghai
Outcome results
None listed