Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

NCT ID: NCT03599180

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-02-01

Brief Summary

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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

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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

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Microdialysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee Osteoarthritis group

KOA patients without accept treat in the past month

microdialysis

Intervention Type DEVICE

Use microdialysis skill to collect dialyzate at sensitization acupoints

Control group

Heathly volunteers

microdialysis

Intervention Type DEVICE

Use microdialysis skill to collect dialyzate at sensitization acupoints

Interventions

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microdialysis

Use microdialysis skill to collect dialyzate at sensitization acupoints

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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
Minimum Eligible Age

38 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Shuguang, Bachelor

Role: STUDY_DIRECTOR

No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China

Locations

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Shuguang

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31702640 (View on PubMed)

Other Identifiers

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81590953

Identifier Type: -

Identifier Source: org_study_id

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