Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Pain in Musculoskeletal System

Completed

• Conditions: Chronic Primary Musculoskeletal Pain
• Interventions: Drug: Compound Nanying zhitong Ointment; Other: Do not use any other similar proprietary medicines or traditional Chinese medicines.

• Registration Number: NCT07200362
• Lead Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd

Brief Summary

A prospective cohort study on the treatment of chronic pain in the musculoskeletal system with Compound Nanxing Pain Relief Ointment. This study adopted an observational research design. Through a cohort study, patient medical records were collected to meet the criteria of chronic pain classification in International Classification of Diseases 11th Revision (ICD-11), which is located in the musculoskeletal system and occurs in the neck and shoulders, waist and back, limbs, and meets the diagnostic criteria of "cold syndrome" in traditional Chinese medicine. The target population was selected to evaluate the clinical effects of Compound Nanxing Pain Relief Ointment in treating chronic pain in the musculoskeletal system, reducing pain, improving muscle and bone function status, and enhancing quality of life. The study aimed to compare the heterogeneity of the clinical effects of Compound Nanxing Pain Relief Ointment in treating chronic pain in the musculoskeletal system. The study plan included 3000 patients, and no intervention in treatment and medication was provided to the patients during the observation period. The shortest medication duration was 2 weeks, and the longest observation period was 3 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-30
• Primary Completion: 2023-06-14
• Study Completion: 2024-02-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3029

Inclusion Criteria

For those who visit the orthopedics department, rheumatology department, or pain clinic:

1. Those whose pain is located in the musculoskeletal system as classified in International Classification of Diseases 11th Revision(ICD-11) for chronic pain, and occurs in the neck, shoulders, waist, back, or limbs;
2. Those who meet the diagnostic criteria of "cold syndrome" in traditional Chinese medicine, and their chronic pain worsens or occurs when exposed to cold;
3. Those with continuous or intermittent pain lasting more than 3 months, and without surgical indications.

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exposed group	Compound Nanying zhitong Ointment	Use Compound Nanying zhitong Ointment alone, or use it in conjunction with conventional Western medicine treatment, without using any other similar Chinese patent medicines or traditional Chinese medicines.
The non-exposure group	Do not use any other similar proprietary medicines or traditional Chinese medicines.	Do not use any other similar proprietary medicines or traditional Chinese medicines.

Primary Outcome Measures

Name	Time	Method
Global Pain Assessment Scale score	The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.	There are a total of 20 items, each rated on a scale of 0 to 10. The total score is calculated by adding up the scores of all items and then dividing by 2. The score range is from 0 to 100. The higher the score, the more severe the pain and its impact.

Secondary Outcome Measures

Name	Time	Method
Pain relief time	The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.	The time required for the VAS score to decrease by ≥50% compared to the baseline.The shorter the duration of pain relief, the better the therapeutic effect.
Time when pain disappears	The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.	The time required for the pain VAS score to be ≤ 2 points and to remain at that level for 24 hours or more.
Number of days without pain episodes	The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.	Record the number of days each month when the patient's affected area is free from pain.
Score of TCM syndromes/signs	The TCM syndrome scores were evaluated on Day 1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.
Score of the Short Form 12 Health Survey (SF-12)	The Short Form 12 Health Survey (SF-12) test was evaluated on day1, as well as at the 2nd, 4th, 8th and 12th weeks after the start of treatment.

Trial Locations

Locations (1)

The Third Affiliated Hospital of Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing Municipality, China