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

NCT07200362 | Completed

• 1 other identifier: CYZZ2038026 SU
• Study Type: observational
• Target: 3,029
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Primary Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Global Pain Assessment Scale score

  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.

  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.

Secondary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

exposed group

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.

Drug: Compound Nanying zhitong Ointment

The non-exposure group

Do not use any other similar proprietary medicines or traditional Chinese medicines.

Other: Do not use any other similar proprietary medicines or traditional Chinese medicines.

Interventions

Compound Nanying zhitong Ointment DRUG

Use Compound Nanying Pain Relief Ointment alone, or use it in conjunction with conventional Western medicine treatment, without using any other similar Chinese patent medicines or traditional Chinese medicines.

exposed group

Do not use any other similar proprietary medicines or traditional Chinese medicines. OTHER

Do not use any other similar proprietary medicines or traditional Chinese medicines.

The non-exposure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• For those who visit the orthopedics department, rheumatology department, or pain clinic:
• 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;
• Those who meet the diagnostic criteria of "cold syndrome" in traditional Chinese medicine, and their chronic pain worsens or occurs when exposed to cold;
• Those with continuous or intermittent pain lasting more than 3 months, and without surgical indications.

You may not qualify if:

• None

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Third Affiliated Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 1, 2025
• Study Start: October 30, 2021
• Primary Completion: June 14, 2023
• Study Completion: February 28, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

CN (1)