Different Kinds of Acupuncture Treatment for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563690
• Other study ID #: 2018ZY008-KOA
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 31, 2022
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Meet the Clinical Classification Criteria for Osteoarthritis of the Knee, diagnosed by specialist.

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:

1. Knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities;

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• treatment1
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.
• treatment2
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.
• treatment3
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.
• treatment4
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.
• treatment5
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.

Drug:
• 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

Locations

Country	Name	City	State
China	The third affiliated hospital of Zhejiang CMU	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Zhejiang Chinese Medical University	Jiaxing TCM Hospital, Red Cross Hospital, Hangzhou, China, The Third Affiliated hospital of Zhejiang Chinese Medical University, Zhejiang Hospital, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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 Ca — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline,2 weeks,4weeks ,3 months,6months
Secondary	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.	baseline,2 weeks,4 weeks ,3 months,6months
Secondary	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.	baseline,2 weeks,4 weeks ,3 months,6months
Secondary	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.	baseline,2 weeks,4 weeks ,3 months,6months
Secondary	Knee swelling measurement change	0-3 score indicating swelling and average Knee circumference of three times.	baseline,2 weeks, 4 weeks ,3 months,6months
Secondary	Expectancy questionnaires	Expectancy questionnaires were comprised of two brief items assessing the expectancy of the patients about acupuncture(or/and)moxibustion.	baseline

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