Chronic Musculoskeletal PainNCT05201365
A Prospective Cohort Study of Compound Nanxing Zhitong Ointment
An observational study of Chronic Musculoskeletal Pain, run by Jiangsu Kanion Pharmaceutical Co., Ltd.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Musculoskeletal Pain
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2024
- 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: 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.
Who may be able to join
- Attendance at orthopedic, rheumatology and pain clinics for.
Who cannot join
- Indication for surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Chronic Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline GPS at week 12.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 12 weeks of treatment, evaluate adverse reactions and make a record.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- chen weiheng, M.D., Study chair, Vice President of the Third Affiliated Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201365
- Sponsor's protocol ID
- Z-FFNX-20211019-01
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. 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 Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05201365
- Acronym / sponsor ID
- Z-FFNX-20211019-01
- Conditions
- Chronic Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 21 Jan 2022 (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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Attendance at orthopedic, rheumatology and pain clinics for.
Key exclusion criteria (1 listed)
- Indication for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Overall Pain Assessment Scale score at week 12 overall Pain Assessment Scale score at week 12.
Time frame: Change from Baseline GPS 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.
5 secondary outcomes
Quality of Life Short Form12,SF-12
Time frame: Total scores at baseline, week 2, week 4, week 8, and week 12 were evaluated in both groups.
Pain resolution time
Time frame: 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
Time frame: 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
Time frame: The TCM evidence score was assessed within 1 hour after treatment. Changes in TCM evidence scores compared to baseline at week 12.
Safety evaluation
Time frame: After 12 weeks of treatment, evaluate adverse reactions and make a record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
chen weiheng, M.D. study chair
Vice President of the Third Affiliated Hospital of Beijing University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Musculoskeletal Pain, run by Jiangsu Kanion Pharmaceutical Co., Ltd.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chen weiheng, M.D. (13511013261 ext. 13511013261, drchenweiheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overall Pain Assessment Scale score at week 12 overall Pain Assessment Scale score at week 12. (time frame: Change from Baseline GPS at week 12.). 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 21 Jan 2022.