A Prospective Cohort Study of Compound Nanxing Zhitong Ointment

Chronic Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05201365
• Other study ID #: Z-FFNX-20211019-01
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: January 2024

Study information

• Verified date: January 2022
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• Contact: chen weiheng, M.D.
• Phone: 13511013261
• Email: drchenweiheng[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: January 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Attendance at orthopedic, rheumatology and pain clinics for.

Exclusion Criteria:

• Indication for surgery.

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Musculoskeletal Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.