A Prospective Cohort Study of Compound Nanxing Zhitong Ointment

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Musculoskeletal Pain

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: chen weiheng, M.D.; Phone Number: 13511013261 13511013261; Email: drchenweiheng@163.com
• Study Contact Backup: Name: kang pengdr, M.D.; Phone Number: 18980601953 18980601953; Email: kangpd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. pain that meets the ICD-11 classification of chronic pain that is localized to the musculoskeletal system and occurs in the neck, shoulder, low back and extremities.
2. Those who meet the criteria of "cold" in Chinese medicine and whose chronic pain is exacerbated by cold.
3. Persistent/intermittent pain for more than 3 months and no indication for surgery.

Description

Inclusion Criteria:

• Attendance at orthopedic, rheumatology and pain clinics for.

Exclusion Criteria:

• Indication for surgery.

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.

Collaborators and Investigators

• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Investigators: Study Chair: chen weiheng, M.D., Vice President of the Third Affiliated Hospital of Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (ACTUAL): January 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 15, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: Z-FFNX-20211019-01

Drug and device information, study documents

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