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A randomized, controlled study is conducted. 120 patients with post-stroke shoulder-shoulder syndrome who meet the inclusion criteria are randomized into treatment group and control group, 60 patients in each group. The treatment group is treated with Qingpeng ointment. The goal of this trial is to verify the clinical efficacy of Tibetan medicine Qingpeng ointment in improving post-stroke shoulder-hand syndrome, and to investigate its effect on pain level, swelling degree, hand movement function, activity and activities of daily living.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Take Qingpeng ointment (produced by Tibet Qizheng Tibetan Medicine Co., Ltd.) and apply it evenly on the shoulder joints, wrist joints and palms of the upper limbs. Press for 20 minutes and have rehabilitation training afer 10 minutes. |
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| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qingpeng Ointment | Drug | Take Qingpeng ointment (produced by Tibet Qizheng Tibetan Medicine Co., Ltd.) and apply it evenly on the shoulder joints, wrist joints and palms of the upper limbs. Press for 20 minutes and have rehabilitation training afer 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Painful degree change of ipsilateral shoulder | Visual analog scale(VAS) is used to test the painful degree. It contains 0-10 scores,while "0"means no pain, "10"means most severe painful.The higher the scores,the more painful. | VAS will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total |
| Motor function change | Using Simplified Fugl-Meyer motion function assessment method to assess the motor function of affected side.The total score of Fugl-Meyer motor function assessment scale is 100 points,50 items intotal with 2 points each. Accordding to the quality of mission completion,evaluater mark score of "0","1",2".Among them, 33 items are evaluated for upper limbs, with a total score of 66 points. And 17 items are evaluated for lower limbs,with a total score of 34 points.The higher the scores, the better motor function.If the total score is less than 50, it means severe dyskinesia.If the total score is between 50-84, it means obvious movement disorder.If the total score is between 85-95, it means moderate dyskinesia.If the total score is between 96-100, it means mild dyskinesia. | This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total |
| Activity of daily living change (ADL) | Using Modified Barthel Index to assess the activity of daily living. TheMBI scale includes 11 items with total scores of 100. Evaluation is based on the actual situation of the patient.The sum of the scores of each item is the total score,and the lowest score is"0",the highest scores is"100".If the scores is between 0-20 points,it means extremely severe dysfunction.If the scores is between 25-45 points,it means severe dysfunction.If the scores is between 50-70 points it means moderate functional defects.If the scores is between 75-95 points,it means mild functional defects.If the scores is 100 points,it means ADL self-care.The higher the total scores,the better the ADL. | This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total |
| Shoulder joint mobility change |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | Safety rating includes 4 levels.Level 1 means "Safe, without any adverse reactions".Level 2 means "Safer, if there is an adverse reaction, you can continue treatment without any treatment ".Level 3 means " Have safety problems, have moderate adverse reactions, and continue treatment after treatment". Level 4 means " Suspension test due to adverse reactions". | After 4 weeks of treatment, evaluate adverse reactions and make a record. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihuan Pan, Doctor | Contact | 020-39318381 | panruihuan@126.com | |
| Shanshan Ling, Master | Contact | 020-39318381 | 1025283737@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongxia Chen, Master | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33308122 | Derived | Pan R, Ling S, Yang H, Huang Y, Zhan L, Zhong Y, Chen H. Clinical Study of Qingpeng Ointment Treating Shoulder-hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period. Comb Chem High Throughput Screen. 2021;24(7):968-975. doi: 10.2174/1386207323666201211093227. |
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Test the shoulder joint mobility with a protractor.The movements of the shoulder joints are as follows:Flexion:70-90°;Stretch:40°;Outreach:80-90°;Adduction:40-60°;Pronation:70-90°;External rotation:15°;Lift up:160-180°.The bigger the degrees,the better the shoulder joint mobility. |
| These will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total |