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Knee OsteoarthritisNCT03563690

Different Kinds of Acupuncture Treatment for Knee Osteoarthritis

A study testing treatment1, treatment2 and treatment3 in people with Knee Osteoarthritis, run by Zhejiang Chinese Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Knee osteoarthritis (KOA) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
treatment1, treatment2 and treatment3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
1 siteChina
Study dates
3 Jul 2018to 31 Dec 2022
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet the Clinical Classification Criteria for Osteoarthritis of the Knee, diagnosed by specialist.
  • Aged 40-75 years old;
  • History of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month;
  • Kellgren and Lawrence Grades 1-3;
  • With related knee pain in one or both knees rated > 4 cm on a 10 cm Visual Analog Scale(VAS) (VAS:0 to 10)
  • Who volunteer to participate and sign the consent form .

Who cannot join

  • Knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities;
  • Patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture;
  • Patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment;
  • Patients who have received acupuncture or needle knife in the past month;
  • Other patients who are not suitable for acupuncture treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The third affiliated hospital of Zhejiang CMU

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Different Kinds of Acupuncture Treatment for Knee Osteoarthritis：a Multicentre Randomised Controlled Trial

Knee osteoarthritis (KOA) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. Acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. The aim of this study is to indicate the effects of three commonly used acupuncture treatments for KOA.

Read the detailed description

360 subjects with KOA recruited from six centers will be randomized to six groups ,and receive four-week acupuncture, Electro-acupuncture, Moxibustion ,Warm-needling ,sham-needle, celebrex treatment. The primary outcomes are Visual Analogue Scale (VAS) and WOMAC function score.The Secondary outcomes are WOMAC pain score, WOMAC stiffness score,the Physical Activity Scale of the Elderly (PASE),knee joint swelling measurement and WHO-BREF life quality scale.The follow-up period is six months. This study will be a rigorous,randomized, sham and drug controlled trial focusing on using different kinds of acupuncture treatment for treating KOA.

Being tested
treatment1, treatment2, treatment3, treatment4, treatment5
Keywords
KOA, Acupuncture treatment, Multi-center RCT
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • treatment1Other

    1. Acupoints：Liangqiu（ST34）,Xuehai（SP10）,Neixiyan（EX-LE4）,Dubi(ST35),Yanglingquan (GB34)and Yinlingquan (SP9)
    2. operation: the needles will be manipulated using techniques including lifting, thrusting, twisting, and rotating, until De Qi is achieved for 30 minutes.

  • treatment2Other

    1. Acupoints：Needling points are the same to the above group
    2. operation: The electrode will be connected Neixiyan (EX-LE4) and Dubi (ST35) and electrode wire will be connected to the electro-acupuncture apparatus using dilatational wave with a frequency of 2/100 Hz, the current intensity is within participants'tolerance, for 30 minutes.

  • treatment3Other

    1. Acupoints：treating points are the same to the above group
    2. Operation: During treatment, participants will choose to sit with knee buckling natural 90 degrees ,with the affected knee(s) exposed. Mild moxibustion are applied at the distance of 2-3 cm away from the skin of both the Neixiyan (EX-LE4) and Dubi (ST35) for 30 minutes.

  • treatment4Other

    1. Acupoints：Needling points are the same to the above group
    2. Operation: Warm-needling acupuncture are applied at both Neixiyan (EX-LE4) and Dubi (ST35). That is to insert one zhuang(about 2cm)of Huai Qing Ai on the top of the needle, and burn the moxa at the lower end ,each acupoint applied 2 Zhuang for 30 minutes.

  • treatment5Other

    1. points：Sham Liangqiu（ST34）,Sham Xuehai(SP10), Sham Neixiyan(EX-LE4), Sham Yanglingquan(GB34),Sham Yinlingquan (SP9)
    2. Operation: Sham acupuncture with non-meridian and non-acupoint needling method, respectively acupuncture 1cm away lateral to the above sham acupoints with a 0.18 * 25mm single-use needle with the depth of 1-2mm.

  • CelebrexDrug

    Drug: Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd), which will be applied 1 time daily( taken 0.2g one time orally ) Time of treatment :4 weeks Other Name: celecoxib

Study groups in NCT03563690
Study groupRoleWhat they receive
Acupuncture groupExperimentalWhen recruited from six centers,the participant will be randomized to six groups .In acupuncture group participant will receive four-week acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Receives: Other: treatment1
Electro-acupuncture groupExperimentalWhen recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week electro-acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Receives: Other: treatment2
Moxibustion groupExperimentalWhen recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week moxibustion treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Receives: Other: treatment3
Warm-needling groupExperimentalWhen recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week warm-needling treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Receives: Other: treatment4
Sham-needle groupSham comparatorWhen recruited from six centers,the participant will be randomized to six groups.In this group participant receive four-week sham acupuncture treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Receives: Other: treatment5
Celebrex groupActive comparatorWhen recruited from six centers,the participant will be randomized to six groups . In this group participant will receive Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd)treatment, which will be applied 1 time daily(one time oral 0.2g) for 4 weeks. The follow-up period is six months.
Receives: Drug: Celebrex

What is being measured

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

  1. Visual Analog Score change

    Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.

    Measured: baseline,2 weeks, 4 weeks ,3 months,6months

  2. WOMAC function change

    The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.

    Measured: baseline,2 weeks,4 weeks ,3 months,6months

Secondary outcomes (6)

  1. WOMAC pain change

    The WOMAC pain subscale referred to the patient's pain. It was comprised of 5 items, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst pain condition. An overall score range of 0 (minimum) to 20 (maximum), with higher scores indicating worse physical function.

    Measured: baseline,2 weeks,4weeks ,3 months,6months

  2. WOMAC stiffness change

    The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.

    Measured: baseline,2 weeks,4 weeks ,3 months,6months

  3. PASE change

    Physical Activity Scale for the Elderly was comprised of 36 questions regarding physical activity of elderly's house hold,leisure,work performance with different score weight.The higher scores indicating better physical activity.

    Measured: baseline,2 weeks,4 weeks ,3 months,6months

  4. Quality of life change

    WHO-BREF 36-Item Form assessing quality of life was comprised of 26 items which measured the following broad domains: physical health, psychological health, social relationships, and environment.With higher scores indicating better quality of life.

    Measured: baseline,2 weeks,4 weeks ,3 months,6months

  5. Knee swelling measurement change

    0-3 score indicating swelling and average Knee circumference of three times.

    Measured: baseline,2 weeks, 4 weeks ,3 months,6months

  6. Expectancy questionnaires

    Expectancy questionnaires were comprised of two brief items assessing the expectancy of the patients about acupuncture(or/and)moxibustion.

    Measured: baseline

Timeline

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

  1. First posted20 Jun 2018
  2. Study start3 Jul 2018
  3. Primary completion28 Oct 2021
  4. Study completion31 Dec 2022

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
Masking
Single blind
Who is masked
Participant
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563690
Sponsor's protocol ID
2018ZY008-KOA
Status last verified
Jun 2023
First submitted
17 May 2018
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.

    PubMed 18279766

  • Gelber AC. Conventional medical therapy for osteoarthritis: current state of the evidence. Curr Opin Rheumatol. 2015 May;27(3):312-7. doi: 10.1097/BOR.0000000000000164.

    PubMed 25784383

  • Holla JF, van der Leeden M, Knol DL, Roorda LD, Hilberdink WK, Lems WF, Steultjens MP, Dekker J. Predictors and outcome of pain-related avoidance of activities in persons with early symptomatic knee osteoarthritis: a five-year followup study. Arthritis Care Res (Hoboken). 2015 Jan;67(1):48-57. doi: 10.1002/acr.22381.

    PubMed 24905958

  • WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.

    PubMed 14679827

  • Xiang YJ, Dai SM. Prevalence of rheumatic diseases and disability in China. Rheumatol Int. 2009 Mar;29(5):481-90. doi: 10.1007/s00296-008-0809-z. Epub 2008 Dec 6.

    PubMed 19066899

  • Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.

    PubMed 14710506

  • Sun J, Liang Y, Luo KT, Shao XM, Tu MQ, Wu XT, Liu F, Li XW, Chen YD, Zhang QF, Ji CH, Li RR, Li XY, Xu F, Fang JQ. Efficacy of Different Acupuncture Techniques for Pain and Dysfunction in Patients with Knee Osteoarthritis: A Randomized Controlled Trial. Pain Ther. 2025 Apr;14(2):737-751. doi: 10.1007/s40122-025-00713-x. Epub 2025 Feb 17.

    PubMed 39961986

  • Zhang Q, Fang J, Chen L, Wu J, Ni J, Liu F, Sun J. Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial. Trials. 2020 Mar 14;21(1):264. doi: 10.1186/s13063-019-4034-8.

    PubMed 32171318

Questions about this trial

What is this clinical trial studying?

A study testing treatment1, treatment2 and treatment3 in people with Knee Osteoarthritis, run by Zhejiang Chinese Medical University 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 5 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: finished, as of the sponsor's last update on 8 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Visual Analog Score change (time frame: baseline,2 weeks, 4 weeks ,3 months,6months). The study lists 2 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 NCT03563690, which also lists 8 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 8 Jun 2023.

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