A Prospective Cohort Study of Compound Nanxing Zhitong Ointment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system

Detailed Description
-----------------
Chronic pain, especially in the musculoskeletal system, is prevalent worldwide. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system. To provide a safe and effective treatment of Chronic Musculoskeletal Pain.

Official Title
-----------------
A Prospective Cohort Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Musculoskeletal Pain

Conditions
-----------------
Chronic Musculoskeletal Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attendance at orthopedic, rheumatology and pain clinics for. Exclusion Criteria: Indication for surgery.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Pain Assessment Scale score at week 12 overall Pain Assessment Scale score at week 12. | Evaluation using Global pain scale, GPS。The change of pain assessment scale score from the beginning period of the treatment to the end indicates the effectiveness of the treatment. The GPS is based on patients' subjective and objective perceptions, and is used to measure patients' overall perceptions of pain. The scores were distributed from 0 to 10, with 0 representing no pain at all and 10 representing the most painful, and the scores were summarized and tallied. Higher scores indicate more severe pain effects. | Change from Baseline GPS at week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Short Form12,SF-12 | SF-12 The raw scores of the 7 dimensions were calculated separately. The scores ranged from 0 to 100, with 0 being the worst and 100 being the best. | Total scores at baseline, week 2, week 4, week 8, and week 12 were evaluated in both groups. | 
| Pain resolution time | Visual analog scale(VAS) is used to test the painful degree. The time taken for a pain VAS score of ≤2 to be maintained for 24 hours or more. | VAS is assessed within 1 hour ahead of the treatment and within 1 hour after the treatment. The change of the score indicate the treatment efficacy. | 
| Number of pain-free days per month | Record the number of days per month that the patient is pain-free in the affected area. | Records are taken every day by the end of the day. Records are assessed at the end of 12 weeks of treatment. | 
| Chinese medicine evidence score | The scale is divided into 2 main aspects, primary and secondary conditions. There are 2 entries for the primary condition. The secondary condition has 8 entries. The entries are scored as 0, 2, 4, and 6 depending on the severity of the symptoms. The total score is 36. The higher the score, the more severe the symptoms. | The TCM evidence score was assessed within 1 hour after treatment. Changes in TCM evidence scores compared to baseline at week 12. | 
| 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. Incidence of adverse events andadverse drug reactions. | After 12 weeks of treatment, evaluate adverse reactions and make a record. |