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Ultrasound Examination of Inguinal Lymph Node Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture treatment
False Needle treatment
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who meet the western medicine diagnostic criteria of knee osteoarthritis;
  2. Aged between 50 and 75 years;
  3. Patients in line with the 0-III level of radiological classification for knee osteoarthritis degeneration;
  4. Patients who did not use glucocorticoid via oral administration or intramuscular, articular, or soft tissue injection four weeks before accepting the test agent;
  5. Normal line of force;
  6. Patients who signed the informed consent and ensured the compliance.

Exclusion Criteria:

  1. Patients with long-term oral administration of agents for knee osteoarthritis, and still in the drug effect period, without elution;
  2. Patients with severe heart, brain, liver, kidney or lung dysfunction;
  3. Patients with other knee diseases found in arthroscopic surgery;
  4. Patients who have accepted other relevant treatments, which may affect the observation on the effects of this study;
  5. Patients with mental illness;
  6. Patients with coagulation dysfunction;
  7. Patients with articular surgical treatment;
  8. Patients with a history of abuse of opioid analgesics, sedative hypnotics or alcohol;
  9. Patients with poor compliance, who were unable to meet the requirements for follow-up.
  10. Pregnant and lactating women.

Sites / Locations

  • Longhua Hospital, Shanghai University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Comparator

The control group

Arm Description

Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

False Needle treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Outcomes

Primary Outcome Measures

Ribbens diagnostic criteria
Ribbens grading of intra-articular effusion in the ultrasonic knee joint.The thickness of > LMM in the anechoic zone was judged to be joint effusion. Classification: level 0: no effusion; level I: small amount of effusion; level II: moderate amount of effusion; level III: large amount of effusion.
Alder blood flow indexing standard
Alder blood flow indexing standard for intra-articular effusion in knee joint by ultrasonic Blood flow classification of articular synovium: level 0: no blood flow signal was found in the synovium;Level I: a small amount of blood flow signals can be seen in the synovium, and the blood flow can be seen at points 1-2.Level II: moderate blood flow signal, 1 main blood vessel or 2-3 small blood vessels can be seen at the same time;Class III: rich blood flow, more than 4 blood vessels are visible, or the blood vessels are connected in a network.
Walther standard synovial thickness
Walther standard synovium thickness is divided into 4 grades, grade I: thickness <2 mm;Class II: thickness 2-5 mm;Class III: thickness 5-9 mm;Class IV: thickness > 9 mm.
Inguinal lymph node volume
Inguinal lymph node
ratio of length to diameter
Inguinal lymph node

Secondary Outcome Measures

Western Ontario and McMaster Universities Index
Western Ontario and McMaster Universities Index for 20 weeks
VAS score
VAS score assessed for 20 weeks.
Lequesne index
Lequesne index assessed for 20 weeks.
Six-minute walking test
Six-minute walking test for 20 weeks.
SF-36 scale
Imaging inspection (MRI) assessed for 20 weeks.

Full Information

First Posted
August 5, 2020
Last Updated
April 17, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04503941
Brief Title
Ultrasound Examination of Inguinal Lymph Node Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis
Official Title
Ultrasound Examination of Inguinal Lymph Node and Knee Joint Slip Fluid Accumulation Was Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. Previous studies on the pathogenesis of this disease mainly focus on cartilage degeneration, but lack of attention to synovitis lesions, and even believe that it is a secondary change in the pathogenesis of osteoarthritis.In recent years, a large number of studies at home and abroad have pointed out that the occurrence and development of knee osteoarthritis are accompanied by synovitis at each stage, and synovial lesions may be the primary manifestation of knee osteoarthritis and affect the evolution of knee osteoarthritis.To this end, some scholars proposed that synovitis lesions as a starting point, may be a new target for the treatment of knee osteoarthritis.
Detailed Description
Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability.Under normal circumstances, synovial fluid in the knee joint cavity is absorbed by lymphatic vessels, and the balance of secretion and absorption of synovial fluid in the knee joint is maintained by the lymphatic system. When there is some kinds of injury of the knee joint synovial received cartilage stimulate, stimulate the synovial vasodilation, synovial cell proliferation activity, produce a large number of joint synovial fluid and secrete a large number of inflammatory liquid, lymphatic metabolism disorder, make joint cavity inflammatory liquid secretion is greater than the absorption, due to the repeated joint fluid absorption and secretion, articular synovial hyperplasia gradually, eventually lost its normal function, a swelling in the knee joint, and the content of inflammatory cytokines in joint fluid, obvious rise, stimulate the immersion in the subchondral bone nerve pain in synovial fluid.In the formation of inflammatory response, the pressure difference between the tissue fluid and the lymphatic vessels promotes the increase of lymphatic reflux, while the input lymphatic vessels tend to converge to the drainage lymph nodes in different regions.Therefore, the observation of changes in lymphatic reflux is more conducive to the evaluation of synovial inflammation and the occurrence of lymph node metastasis. Therefore, regional drainage lymph node metastasis can also be used as an important biological indicator for the evaluation of prognosis and the formulation of treatment strategies. Acupuncture could be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study with clear design, standard criteria, control group, will be started to confirm the effects of long term for acupuncture treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 120 patients were enrolled and treated in either the sham-acupuncture (control group) or acupuncture group for 12 weeks, with 8 weeks' follow-up, three times per week.
Masking
Participant
Masking Description
Since the acupuncture and sham-acupuncture cannot be blind to the researchers, considering the placebo effect of the subjects, this experiment was blind only to the subjects, namely single-blind. But the researchers did not hint at the treatments received by the patients, and avoided various factors that may have led to bias during the trial.
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator
Arm Type
Experimental
Arm Description
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
False Needle treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Intervention Type
Device
Intervention Name(s)
Acupuncture treatment
Intervention Description
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Intervention Type
Device
Intervention Name(s)
False Needle treatment
Intervention Description
False Needle treatment treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Primary Outcome Measure Information:
Title
Ribbens diagnostic criteria
Description
Ribbens grading of intra-articular effusion in the ultrasonic knee joint.The thickness of > LMM in the anechoic zone was judged to be joint effusion. Classification: level 0: no effusion; level I: small amount of effusion; level II: moderate amount of effusion; level III: large amount of effusion.
Time Frame
20 weeks
Title
Alder blood flow indexing standard
Description
Alder blood flow indexing standard for intra-articular effusion in knee joint by ultrasonic Blood flow classification of articular synovium: level 0: no blood flow signal was found in the synovium;Level I: a small amount of blood flow signals can be seen in the synovium, and the blood flow can be seen at points 1-2.Level II: moderate blood flow signal, 1 main blood vessel or 2-3 small blood vessels can be seen at the same time;Class III: rich blood flow, more than 4 blood vessels are visible, or the blood vessels are connected in a network.
Time Frame
20 weeks
Title
Walther standard synovial thickness
Description
Walther standard synovium thickness is divided into 4 grades, grade I: thickness <2 mm;Class II: thickness 2-5 mm;Class III: thickness 5-9 mm;Class IV: thickness > 9 mm.
Time Frame
20 weeks
Title
Inguinal lymph node volume
Description
Inguinal lymph node
Time Frame
20 weeks
Title
ratio of length to diameter
Description
Inguinal lymph node
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Index
Description
Western Ontario and McMaster Universities Index for 20 weeks
Time Frame
20 weeks
Title
VAS score
Description
VAS score assessed for 20 weeks.
Time Frame
20 weeks
Title
Lequesne index
Description
Lequesne index assessed for 20 weeks.
Time Frame
20 weeks
Title
Six-minute walking test
Description
Six-minute walking test for 20 weeks.
Time Frame
20 weeks
Title
SF-36 scale
Description
Imaging inspection (MRI) assessed for 20 weeks.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet the western medicine diagnostic criteria of knee osteoarthritis; Aged between 50 and 75 years; Patients in line with the 0-III level of radiological classification for knee osteoarthritis degeneration; Patients who did not use glucocorticoid via oral administration or intramuscular, articular, or soft tissue injection four weeks before accepting the test agent; Normal line of force; Patients who signed the informed consent and ensured the compliance. Exclusion Criteria: Patients with long-term oral administration of agents for knee osteoarthritis, and still in the drug effect period, without elution; Patients with severe heart, brain, liver, kidney or lung dysfunction; Patients with other knee diseases found in arthroscopic surgery; Patients who have accepted other relevant treatments, which may affect the observation on the effects of this study; Patients with mental illness; Patients with coagulation dysfunction; Patients with articular surgical treatment; Patients with a history of abuse of opioid analgesics, sedative hypnotics or alcohol; Patients with poor compliance, who were unable to meet the requirements for follow-up. Pregnant and lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, Ph.D, M.D
Organizational Affiliation
Shanghai Longhua Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Longhua Hospital, Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
available
Citations:
PubMed Identifier
30144298
Citation
Wang W, Lin X, Xu H, Sun W, Bouta EM, Zuscik MJ, Chen D, Schwarz EM, Xing L. Attenuated Joint Tissue Damage Associated With Improved Synovial Lymphatic Function Following Treatment With Bortezomib in a Mouse Model of Experimental Posttraumatic Osteoarthritis. Arthritis Rheumatol. 2019 Feb;71(2):244-257. doi: 10.1002/art.40696. Epub 2019 Jan 5.
Results Reference
result
PubMed Identifier
12970463
Citation
Ribbens C, Andre B, Marcelis S, Kaye O, Mathy L, Bonnet V, Beckers C, Malaise MG. Rheumatoid hand joint synovitis: gray-scale and power Doppler US quantifications following anti-tumor necrosis factor-alpha treatment: pilot study. Radiology. 2003 Nov;229(2):562-9. doi: 10.1148/radiol.2292020206. Epub 2003 Sep 11.
Results Reference
result
PubMed Identifier
11229463
Citation
Walther M, Harms H, Krenn V, Radke S, Faehndrich TP, Gohlke F. Correlation of power Doppler sonography with vascularity of the synovial tissue of the knee joint in patients with osteoarthritis and rheumatoid arthritis. Arthritis Rheum. 2001 Feb;44(2):331-8. doi: 10.1002/1529-0131(200102)44:23.0.CO;2-0.
Results Reference
result
PubMed Identifier
11824968
Citation
Wauke K, Nagashima M, Ishiwata T, Asano G, Yoshino S. Expression and localization of vascular endothelial growth factor-C in rheumatoid arthritis synovial tissue. J Rheumatol. 2002 Jan;29(1):34-8.
Results Reference
result
PubMed Identifier
18050199
Citation
Proulx ST, Kwok E, You Z, Papuga MO, Beck CA, Shealy DJ, Ritchlin CT, Awad HA, Boyce BF, Xing L, Schwarz EM. Longitudinal assessment of synovial, lymph node, and bone volumes in inflammatory arthritis in mice by in vivo magnetic resonance imaging and microfocal computed tomography. Arthritis Rheum. 2007 Dec;56(12):4024-37. doi: 10.1002/art.23128.
Results Reference
result
PubMed Identifier
25261425
Citation
Melo Mde O, Pompeo KD, Brodt GA, Baroni BM, da Silva Junior DP, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on the muscle architecture and functional capacity in elderly patients with knee osteoarthritis: a randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):570-80. doi: 10.1177/0269215514552082. Epub 2014 Sep 26.
Results Reference
result
PubMed Identifier
26311723
Citation
Glimm AM, Werner SG, Burmester GR, Backhaus M, Ohrndorf S. Analysis of distribution and severity of inflammation in patients with osteoarthitis compared to rheumatoid arthritis by ICG-enhanced fluorescence optical imaging and musculoskeletal ultrasound: a pilot study. Ann Rheum Dis. 2016 Mar;75(3):566-70. doi: 10.1136/annrheumdis-2015-207345. Epub 2015 Aug 26.
Results Reference
result

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Ultrasound Examination of Inguinal Lymph Node Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis

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