NCT03563690

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

May 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

July 3, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

3.3 years

First QC Date

May 17, 2018

Last Update Submit

June 6, 2023

Conditions

Knee Osteoarthritis

Keywords

KOAAcupuncture treatmentMulti-center RCT

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (6)

  • WOMAC pain change

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

  • WOMAC stiffness change

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

  • PASE change

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

  • Quality of life change

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

  • Knee swelling measurement change

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

  • +1 more secondary outcomes

Study Arms (6)

Acupuncture group

EXPERIMENTAL

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.

Other: treatment1

Electro-acupuncture group

EXPERIMENTAL

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.

Other: treatment2

Moxibustion group

EXPERIMENTAL

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.

Other: treatment3

Warm-needling group

EXPERIMENTAL

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.

Other: treatment4

Sham-needle group

SHAM COMPARATOR

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.

Other: treatment5

Celebrex group

ACTIVE COMPARATOR

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.

Drug: Celebrex

Interventions

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.

Acupuncture group
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.

Electro-acupuncture group
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.

Moxibustion group
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.

Warm-needling group
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.

Sham-needle group
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

Celebrex group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third affiliated hospital of Zhejiang CMU

Hangzhou, Zhejiang, China

Location

Related Publications (8)

  • 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.

    PMID: 18279766BACKGROUND

  • 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.

    PMID: 25784383BACKGROUND

  • 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.

    PMID: 24905958RESULT

  • 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.

    PMID: 14679827RESULT

  • 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.

    PMID: 19066899RESULT

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

    PMID: 14710506RESULT

  • 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.

    PMID: 39961986DERIVED

  • 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.

    PMID: 32171318DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jianqiao Fang, Ph.D,M.D

    Zhejiang CMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 20, 2018

Study Start

July 3, 2018

Primary Completion

October 28, 2021

Study Completion

December 31, 2022

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

CN(1)