Different Kinds of Acupuncture Treatment for Knee Osteoarthritis
NCT ID: NCT03563690
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2018-07-03
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture group
When 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.
treatment1
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.
Electro-acupuncture group
When 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.
treatment2
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.
Moxibustion group
When 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.
treatment3
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.
Warm-needling group
When 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.
treatment4
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.
Sham-needle group
When 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.
treatment5
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.
Celebrex group
When 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.
Celebrex
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
Interventions
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treatment1
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.
treatment2
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.
treatment3
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.
treatment4
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.
treatment5
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.
Celebrex
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
Eligibility Criteria
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Inclusion Criteria
2. Aged 40-75 years old;
3. History of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month;
4. Kellgren and Lawrence Grades 1-3;
5. With related knee pain in one or both knees rated \> 4 cm on a 10 cm Visual Analog Scale(VAS) (VAS:0 to 10)
6. Who volunteer to participate and sign the consent form .
Exclusion Criteria
2. Patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture;
3. Patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment;
4. Patients who have received acupuncture or needle knife in the past month;
5. Other patients who are not suitable for acupuncture treatment.
40 Years
75 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Jiaxing TCM Hospital
UNKNOWN
Zhejiang Provincial Hospital of TCM
OTHER
Zhejiang Hospital
OTHER
Red Cross Hospital, Hangzhou, China
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Zhejiang Chinese Medical University
OTHER_GOV
Responsible Party
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Jianqiao Fang
President
Principal Investigators
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Jianqiao Fang, Ph.D,M.D
Role: PRINCIPAL_INVESTIGATOR
Zhejiang CMU
Locations
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The third affiliated hospital of Zhejiang CMU
Hangzhou, Zhejiang, China
Countries
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References
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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.
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.
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.
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.
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.
Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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2018ZY008-KOA
Identifier Type: -
Identifier Source: org_study_id
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