Clinical trial NCT03563690: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: KOA
Acupuncture treatment
Multi-center RCT
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Jiaxing TCM Hospital
name: Zhejiang Provincial Hospital of TCM
name: Zhejiang Hospital
name: Red Cross Hospital, Hangzhou, China
name: Zhejiang Provincial Tongde Hospital
First posted: 2018-06-20
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Score change
timeFrame: baseline,2 weeks, 4 weeks ,3 months,6months
measure: WOMAC function change
timeFrame: baseline,2 weeks,4 weeks ,3 months,6months
Secondary outcomes:
measure: WOMAC pain change
timeFrame: baseline,2 weeks,4weeks ,3 months,6months
measure: WOMAC stiffness change
timeFrame: baseline,2 weeks,4 weeks ,3 months,6months
measure: PASE change
timeFrame: baseline,2 weeks,4 weeks ,3 months,6months
measure: Quality of life change
timeFrame: baseline,2 weeks,4 weeks ,3 months,6months
measure: Knee swelling measurement change
timeFrame: baseline,2 weeks, 4 weeks ,3 months,6months
measure: Expectancy questionnaires
timeFrame: baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The third affiliated hospital of Zhejiang CMU
state: Zhejiang
Study officials:
affiliation: Zhejiang CMU
name: Jianqiao Fang, Ph.D,M.D
role: PRINCIPAL_INVESTIGATOR
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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.