Back to resultsDifferent Kinds of Acupuncture Treatment for Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
treatment1
treatment2
treatment3
treatment4
treatment5
Celebrex
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring KOA, Acupuncture treatment, Multi-center RCT
Eligibility Criteria
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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.
Sites / Locations
- The third affiliated hospital of Zhejiang CMU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Sham Comparator
Active Comparator
Arm Label
Acupuncture group
Electro-acupuncture group
Moxibustion group
Warm-needling group
Sham-needle group
Celebrex group
Arm Description
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Knee swelling measurement change
0-3 score indicating swelling and average Knee circumference of three times.
Expectancy questionnaires
Expectancy questionnaires were comprised of two brief items assessing the expectancy of the patients about acupuncture(or/and)moxibustion.
Full Information
NCT ID
NCT03563690
First Posted
May 17, 2018
Last Updated
June 6, 2023
Sponsor
Zhejiang Chinese Medical University
Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University, Jiaxing TCM Hospital, Zhejiang Provincial Hospital of TCM, Zhejiang Hospital, Red Cross Hospital, Hangzhou, China, Zhejiang Provincial Tongde Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03563690
Brief Title
Different Kinds of Acupuncture Treatment for Knee Osteoarthritis
Official Title
Different Kinds of Acupuncture Treatment for Knee Osteoarthritis：a Multicentre Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University
Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University, Jiaxing TCM Hospital, Zhejiang Provincial Hospital of TCM, Zhejiang Hospital, Red Cross Hospital, Hangzhou, China, Zhejiang Provincial Tongde Hospital
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) 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
KOA, Acupuncture treatment, Multi-center RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
Electro-acupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
Moxibustion group
Arm Type
Experimental
Arm Description
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.
Arm Title
Warm-needling group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-needle group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Celebrex group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
treatment1
Intervention Description
Acupoints：Liangqiu（ST34）,Xuehai（SP10）,Neixiyan（EX-LE4）,Dubi(ST35),Yanglingquan (GB34)and Yinlingquan (SP9)
operation: the needles will be manipulated using techniques including lifting, thrusting, twisting, and rotating, until De Qi is achieved for 30 minutes.
Intervention Type
Other
Intervention Name(s)
treatment2
Intervention Description
Acupoints：Needling points are the same to the above group
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.
Intervention Type
Other
Intervention Name(s)
treatment3
Intervention Description
Acupoints：treating points are the same to the above group
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.
Intervention Type
Other
Intervention Name(s)
treatment4
Intervention Description
Acupoints：Needling points are the same to the above group
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.
Intervention Type
Other
Intervention Name(s)
treatment5
Intervention Description
points：Sham Liangqiu（ST34）,Sham Xuehai(SP10), Sham Neixiyan(EX-LE4), Sham Yanglingquan(GB34),Sham Yinlingquan (SP9)
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.
Intervention Type
Drug
Intervention Name(s)
Celebrex
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog Score change
Description
Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.
Time Frame
baseline,2 weeks, 4 weeks ,3 months,6months
Title
WOMAC function change
Description
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.
Time Frame
baseline,2 weeks,4 weeks ,3 months,6months
Secondary Outcome Measure Information:
Title
WOMAC pain change
Description
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.
Time Frame
baseline,2 weeks,4weeks ,3 months,6months
Title
WOMAC stiffness change
Description
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.
Time Frame
baseline,2 weeks,4 weeks ,3 months,6months
Title
PASE change
Description
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.
Time Frame
baseline,2 weeks,4 weeks ,3 months,6months
Title
Quality of life change
Description
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.
Time Frame
baseline,2 weeks,4 weeks ,3 months,6months
Title
Knee swelling measurement change
Description
0-3 score indicating swelling and average Knee circumference of three times.
Time Frame
baseline,2 weeks, 4 weeks ,3 months,6months
Title
Expectancy questionnaires
Description
Expectancy questionnaires were comprised of two brief items assessing the expectancy of the patients about acupuncture(or/and)moxibustion.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 .
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianqiao Fang, Ph.D,M.D
Organizational Affiliation
Zhejiang CMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
The third affiliated hospital of Zhejiang CMU
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
18279766
Citation
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.
Results Reference
background
PubMed Identifier
25784383
Citation
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.
Results Reference
background
PubMed Identifier
24905958
Citation
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.
Results Reference
result
PubMed Identifier
14679827
Citation
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.
Results Reference
result
PubMed Identifier
19066899
Citation
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.
Results Reference
result
PubMed Identifier
14710506
Citation
Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
Results Reference
result
PubMed Identifier
32171318
Citation
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.
Results Reference
derived
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Different Kinds of Acupuncture Treatment for Knee Osteoarthritis
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