Clinical Study of Qingpeng Ointment in Treating Shoulder Syndrome During Rehabilitation Period of Cerebral Hemorrhage

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.

Study Overview

• Status: Unknown
• Conditions: The Efficacy of Qingpeng Ointment
• Intervention / Treatment: Drug: Qingpeng Ointment

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Provincial Hospital of Chinese Medicine
      • Contact: Hongxia Chen, MM; Phone Number: +8613609031028; Email: chx2004@126.com
      • Contact: Shanshan Ling, Master; Phone Number: +8615626450762; Email: 1025286737@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet the diagnostic criteria for stroke;
2. Meet the diagnostic criteria for shoulder-hand syndrome, stage I
3. The course of disease is between 15 days and 6 months;
4. Consciousness, no serious cognitive impairment, with examination and treatment;
5. Age between 20 and 80 years old;
6. Sign the informed consent form and volunteer to participate in the study.

Exclusion Criteria:

1. Repeated stroke patients or shoulder-hand syndrome patients with repeated attacks or exacerbations;
2. The course of stroke is >6 months;
3. Those with serious heart, liver and kidney diseases and moderate to severe infections;
4. Unconsciousness or a combination of incompetent cognitive impairment and complete aphasia.
5. Take painkillers or other treatments that treat shoulder pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Treatment Group; 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.	Drug: Qingpeng Ointment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Hongxia Chen, Master, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Qingpeng Ointment; Shoulder Syndrome; Rehabilitation Period of Cerebral Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: JDZX2015224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No