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NCT Number: NCT03599180

Clinical Protocol of Sensitized Acupoint 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.

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Key information

Age range

38 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shuguang

Chengdu, Sichuan, 610075, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microdialysis

Device

Use microdialysis skill to collect dialyzate at sensitization acupoints

Primary outcomes

  1. 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.

Secondary outcomes

  1. Histamine concentration

    Time frame: 2018-7-12---2020-7-1

    The histamine concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

  2. Adenosine triphosphate concentration

    Time frame: 2018-7-12---2020-7-1

    The adenosine triphosphate concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

  3. WOMAC score

    Time frame: 2018-7-12---2020-7-1

    The WOMAC score of KOA patients was compared with healthy volunteers.

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Official study title

Clinical Research Protocol of Systematic Biology Mechanism for Sensitized Acupoint Micro-physicochemical Environment Changes in Knee Osteoarthritis Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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