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Knee OsteoarthritisNCT04503941

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

A study testing Acupuncture treatment and False Needle treatment in people with Knee Osteoarthritis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Acupuncture treatment and False Needle treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
1 siteChina
Study dates
1 Jun 2021to 1 May 2025
Phase
Interventional
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Longhua Hospital, Shanghai University of TCM

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Acupuncture treatment, False Needle treatment
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture treatmentDevice

    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 treatmentDevice

    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.

Study groups in NCT04503941
Study groupRoleWhat they receive
Active ComparatorExperimentalAcupuncture 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.
Receives: Device: Acupuncture treatment
The control groupPlacebo comparatorFalse 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.
Receives: Device: False Needle treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 weeks

  2. 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.

    Measured: 20 weeks

  3. 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.

    Measured: 20 weeks

  4. Inguinal lymph node volume

    Inguinal lymph node

    Measured: 20 weeks

  5. ratio of length to diameter

    Inguinal lymph node

    Measured: 20 weeks

Secondary outcomes (5)
  1. Western Ontario and McMaster Universities Index

    Western Ontario and McMaster Universities Index for 20 weeks

    Measured: 20 weeks

  2. VAS score

    VAS score assessed for 20 weeks.

    Measured: 20 weeks

  3. Lequesne index

    Lequesne index assessed for 20 weeks.

    Measured: 20 weeks

  4. Six-minute walking test

    Six-minute walking test for 20 weeks.

    Measured: 20 weeks

  5. SF-36 scale

    Imaging inspection (MRI) assessed for 20 weeks.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2020
  2. Study start1 Jun 2021
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04503941
Sponsor's protocol ID
UE of OA
Status last verified
Mar 2023
First submitted
5 Aug 2020
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: available

Publications

  • 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.

    PubMed 30144298
  • 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.

    PubMed 12970463
  • 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.

    PubMed 11229463
  • 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.

    PubMed 11824968
  • 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.

    PubMed 18050199
  • 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.

    PubMed 25261425
  • 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.

    PubMed 26311723

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture treatment and False Needle treatment in people with Knee Osteoarthritis, run by Shanghai University of Traditional Chinese Medicine 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Ribbens diagnostic criteria (time frame: 20 weeks). The study lists 5 primary outcomes in all. 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 NCT04503941, which also lists 7 linked publications.

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 18 Apr 2023.

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