Chronic Primary Musculoskeletal PainNCT07200362
Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Pain in Musculoskeletal System
An observational study of Chronic Primary Musculoskeletal Pain, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Primary Musculoskeletal Pain
- What is being tested?
- Compound Nanying zhitong Ointment and Do not use any other similar proprietary medicines or traditional Chinese medicines.
- How many people
- 3,029 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2021to 28 Feb 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100029
About this study
Official title: A Prospective Cohort Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Pain in the Musculoskeletal System
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
- Being tested
- Compound Nanying zhitong Ointment, Do not use any other similar proprietary medicines or traditional Chinese medicines.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Nanying zhitong OintmentDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Compound Nanying zhitong Ointment | |
| The non-exposure group | Do not use any other similar proprietary medicines or traditional Chinese medicines. Receives: Other: Do not use any other similar proprietary medicines or traditional Chinese medicines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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 time required for the pain VAS score to be ≤ 2 points and to remain at that level for 24 hours or more.
Measured: 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
Record the number of days each month when the patient's affected area is free from pain.
Measured: 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
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start30 Oct 2021
- Primary completion14 Jun 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Primary Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,029 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200362
- Sponsor's protocol ID
- CYZZ2038026 SU
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Pain in the Musculoskeletal System
- ClinicalTrials.gov ID
- NCT07200362
- Acronym / sponsor ID
- CYZZ2038026 SU
- Conditions
- Chronic Primary Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,029 participants (actual)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Drug: Compound Nanying zhitong OintmentUse 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 | – | Other: Do not use any other similar proprietary medicines or traditional Chinese medicines.Do not use any other similar proprietary medicines or traditional Chinese medicines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Nanying zhitong OintmentUse 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. | Drug | exposed 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. | Other | The non-exposure group |
Primary outcome
Global Pain Assessment Scale score
Time frame: 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.
5 secondary outcomes
Pain relief time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Related trials for Chronic Primary Musculoskeletal Pain
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Primary Musculoskeletal Pain, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Pain Assessment Scale score (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.