MicrodialysisNCT03599180
Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients
An observational study of Microdialysis, run by Chinese Medical Association at 1 site in China.
Trial summary
Based on the research background and the preliminary research basis of the research group, in order to answer the material basis and micro-physical environment change characteristics of knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study of sensitization of acupoints. Read more about this study
- Who is it for?
- Ages 38 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Microdialysis
- What is being tested?
- microdialysis
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Feb 2020
- 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 38 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 32 KOA patients and 32 normal volunteers will be included
Who may be able to join
- Meets the diagnosis criteria of knee osteoarthritis. Age between 45 and 70 years. Meets imaging examination X-ray Kellgren and Laerence classification standards grade I-III.
- Patients who meet the criteria for early or mid-term stage of knee osteoarthritis.
- Discontinue use of pain medications and hormone drugs during the trial. The patient's vital signs are stable, can read his own medical history, and can cooperate with the relevant examination and treatment.
- Signed the informed consent voluntarily.
Who cannot join
- Seriously patients with surgical indications Associated systemic arthropathies, e.g. rheumatoid arthritis and gout Heart failure Bleeding diathesis Liver failure knee arthroplasty There are diseases that may seriously endanger life, such as cardiovascular and cerebrovascular diseases, renal and liver failure, hematopoietic system diseases, etc.
- Patients with mental illnesses that cannot be completed or are not suitable for treatment and examination Patients who received treatment including traditional Chinese medicine, western medicine, acupuncture, massage and physiotherapy within the past month Patients on steroids History of intra articular injection of steroid within last six months Joint irrigation or arthroscopy has been performed within the past year Have had knee arthroplasty At the same time participate in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research Protocol of Systematic Biology Mechanism for Sensitized Acupoint Micro-physicochemical Environment Changes in Knee Osteoarthritis Patients
Based on the research background and the preliminary research basis of the research group, in order to answer the material basis and micro-physical environment change characteristics of knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study of sensitization of acupoints. This study plans to use knee osteoarthritis as a research vehicle, and use microdialysis combined with high performance liquid chromatography to analyze the local material basis and key indicators of common sensitization points in knee osteoarthritis.
Read the detailed description
This trial is a single-centre, normal controlled, parallel group, clinical trial. The trial is an explorative, pilot trial designed to reveal the change of the main material group in sensitized acupoints caused by knee osteoarthritis, and provide the key signal substance and its changing characteristics of knee osteoarthritis sensitized acupoints.
- Conditions
- Microdialysis
- Being tested
- microdialysis
- Keywords
- Knee Osteoarthritis, Sensitized Acupoints, Microdialysis, High performance liquid chromatography（HPLC）
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microdialysisDevice
Use microdialysis skill to collect dialyzate at sensitization acupoints
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis group | KOA patients without accept treat in the past month Receives: Device: microdialysis | |
| Control group | Heathly volunteers Receives: Device: microdialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotonin concentration
The serotonin concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.
Measured: 2018-7-12---2020-7-1
Secondary outcomes (3)
Histamine concentration
The histamine concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.
Measured: 2018-7-12---2020-7-1
Adenosine triphosphate concentration
The adenosine triphosphate concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.
Measured: 2018-7-12---2020-7-1
WOMAC score
The WOMAC score of KOA patients was compared with healthy volunteers.
Measured: 2018-7-12---2020-7-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Sep 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrodialysisStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yu Shuguang, Bachelor, Study director, No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599180
- Sponsor's protocol ID
- 81590953
- Status last verified
- Jun 2018
- First submitted
- 15 Jul 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li S, Chai XN, Zuo CY, Lv P, Tang Y, Tan HJ, Liu LZ, Yin HY, Yu SG. Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol. Medicine (Baltimore). 2019 Nov;98(45):e17843. doi: 10.1097/MD.0000000000017843.
PubMed 31702640
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Protocol of Systematic Biology Mechanism for Sensitized Acupoint Micro-physicochemical Environment Changes in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT03599180
- Acronym / sponsor ID
- 81590953
- Conditions
- Microdialysis
- Keywords
- Knee Osteoarthritis, Sensitized Acupoints, Microdialysis, High performance liquid chromatography（HPLC）
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 26 Jul 2018 (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.
Based on the research background and the preliminary research basis of the research group, in order to answer the material basis and micro-physical environment change characteristics of knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study of sensitization of acupoints. This study plans to use knee osteoarthritis as a research vehicle, and use microdialysis combined with high performance liquid chromatography to analyze the local material basis and key indicators of common sensitization points in knee osteoarthritis.
Detailed description
This trial is a single-centre, normal controlled, parallel group, clinical trial. The trial is an explorative, pilot trial designed to reveal the change of the main material group in sensitized acupoints caused by knee osteoarthritis, and provide the key signal substance and its changing characteristics of knee osteoarthritis sensitized acupoints.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis group | – | Device: microdialysisKOA patients without accept treat in the past month |
| Control group | – | Device: microdialysisHeathly volunteers |
Who may qualify
- Ages
- 38 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 32 KOA patients and 32 normal volunteers will be included
Key inclusion criteria (4 listed)
- Meets the diagnosis criteria of knee osteoarthritis. Age between 45 and 70 years. Meets imaging examination X-ray Kellgren and Laerence classification standards grade I-III.
- Patients who meet the criteria for early or mid-term stage of knee osteoarthritis.
- Discontinue use of pain medications and hormone drugs during the trial. The patient's vital signs are stable, can read his own medical history, and can cooperate with the relevant examination and treatment.
- Signed the informed consent voluntarily.
Key exclusion criteria (2 listed)
- Seriously patients with surgical indications Associated systemic arthropathies, e.g. rheumatoid arthritis and gout Heart failure Bleeding diathesis Liver failure knee arthroplasty There are diseases that may seriously endanger life, such as cardiovascular and cerebrovascular diseases, renal and liver failure, hematopoietic system diseases, etc.
- Patients with mental illnesses that cannot be completed or are not suitable for treatment and examination Patients who received treatment including traditional Chinese medicine, western medicine, acupuncture, massage and physiotherapy within the past month Patients on steroids History of intra articular injection of steroid within last six months Joint irrigation or arthroscopy has been performed within the past year Have had knee arthroplasty At the same time participate in other studies
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 |
|---|---|---|
| microdialysisUse microdialysis skill to collect dialyzate at sensitization acupoints | Device | Control group, Knee Osteoarthritis group |
Primary outcome
Serotonin concentration
Time frame: 2018-7-12---2020-7-1
The serotonin concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.
3 secondary outcomes
Histamine concentration
Time frame: 2018-7-12---2020-7-1
Adenosine triphosphate concentration
Time frame: 2018-7-12---2020-7-1
WOMAC score
Time frame: 2018-7-12---2020-7-1
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 12 Feb 2020.
- Derived from this study: PubMed 31702640Li S, Chai XN, Zuo CY, Lv P, Tang Y, Tan HJ, Liu LZ, Yin HY, Yu SG. Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol. Medicine (Baltimore). 2019 Nov;98(45):e17843. doi: 10.1097/MD.0000000000017843.
- Individual participant dataSharing planned: No
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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.
Yu Shuguang, Bachelor study director
No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China
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 Microdialysis, run by Chinese Medical Association 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 2 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 12 Feb 2020. 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?
Serotonin concentration (time frame: 2018-7-12---2020-7-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599180, which also lists 1 linked publication.
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 12 Feb 2020.