NCT06553313

Brief Summary

In the previous study "Using omics technology to explore the mechanism of acupuncture treatment of different acupoints of knee osteoarthritis: a randomized controlled trial (CMUH109-REC3-113)", we found that acupuncture for knee osteoarthritis(KOA) significantly reduces inflammation, apoptosis, and metabolism-related serum protein profiles. However, due to the lack of serum protein data from the control group, it is impossible to establish standard values for comparison. To analyze the protein expression in the serum of KOA control group subjects, we also measured the spectral energy values of the radial artery pulse wave obtained from the pulse sphygmograph and the meridian energy values obtained from Ryodoraku. The results obtained can be compared with previous studies, thus this experiment was designed.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 4, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

August 4, 2024

Last Update Submit

August 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Micro-Western Array and Enzyme-linked immunosorbent assay

    Obtaining the serum protein content value

    the first and the fifth weeks

Secondary Outcomes (1)

  • pulse sphygmograph and Ryodoraku

    the first and the fifth weeks

Study Arms (1)

the control group of knee arthritis

OTHER

Monitoring the stability of protein expression, pulse wave and meridian energy in the serum of the KOA control group (participants without knee pain).

Device: Micro-Western Array

Interventions

The subjects first took the energy measurement of the pulse sphygmograph and Ryodoraku, rested for 20 minutes, and then repeated the measurements again. In order to comply with the acupuncture treatment course was 5 weeks in the previous study, we have two blood draw point. Each subject's blood was drawn for the first time, and then for the second time in 5 weeks later. Each subject drew 10ml of blood each time. The blood samples are analyzed by Micro-Western Array (MWA) and Enzyme-linked immunosorbent assay (ELISA) to obtain the serum protein content value of healthy individuals.

Also known as: Enzyme-linked immunosorbent assay, pulse sphygmograph, Ryodoraku
the control group of knee arthritis

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 50 years old without knee pain

You may not qualify if:

  • Clinical diagnosis of knee osteoarthritis
  • Taking anti-inflammatory and analgesic drugs in the past month
  • Taking blood-lipid-lowering drugs or health foods in the past month
  • Received any acupuncture treatment in the past 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Wan-Zhen Yu

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 14, 2024

Study Start

August 4, 2024

Primary Completion

July 23, 2025

Study Completion

July 23, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations