Clinical trial NCT03366363: Acupuncture Therapy for Knee Osteoarthritis
Official title: Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
acupuncture
electroacupuncture
sham acupuncture
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing science and technology commission
First posted: 2017-12-08
Enrollment: 480
Sex: ALL
Minimum age (years): 45
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), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needles are placed into the body at specific points. Studies have shown that acupuncture can stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). However the evidences of acupuncture for KOA are contradictory. According to the review, intensive acupuncture with three sessions a week is more effective for KOA than sparse acupuncture with one session a week. Moreover, the papers published in the past years suggest that manual acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the treatment of knee osteoarthritis. The aim of this study is to evaluate the efficacy of intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain and improving function in patients with KOA.


Eligibility criteria: Inclusion Criteria:

1. Age 45-75 years old, male or female
2. Single / bilateral knee pain, duration of more than 6 months
3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ
4. NRS ≥ 4

Exclusion Criteria:

1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, fracture, gout, lumbosacral vertebrae disease, etc.)
3. History of arthroscopy within 1 year or intra-articular injection within 4 months
4. History of receiving acupuncture or massage treatment within 3 months
5. Severe acute/chronic organic or mental diseases
6. Coagulation disorders (such as hemophilia, etc.)
7. Cardiac pacemaker, metal allergy or needle phobia
8. Pregnant women, pregnant and lactating women
9. Participation in another clinical study in the past 3 months

Primary outcomes:
measure: Response rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Response rate
timeFrame: 16 weeks, 26 weeks
measure: Knee-joint pain
timeFrame: baseline, 8 weeks, 16 weeks and 26 weeks
measure: Knee-joint pain
timeFrame: baseline, 8 weeks, 16 weeks and 26 weeks
measure: Knee-joint function
timeFrame: baseline, 8 weeks, 16 weeks and 26 weeks
measure: Knee-joint stiffness
timeFrame: baseline, 8 weeks, 16 weeks and 26 weeks
measure: Quality of life
timeFrame: baseline, 8 weeks, 16 weeks and 26 weeks
measure: Credibility score
timeFrame: 1 week（after the first treatment）
measure: Expectancy score
timeFrame: 1 week（after the first treatment）
measure: Blinding assessment
timeFrame: 4 weeks and 8 weeks
measure: Global effect
timeFrame: 8 weeks, 16 weeks and 26 weeks
measure: Adverse events
timeFrame: first treatment up to 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
state: Beijing
city: Beijing
country: China
facility: Guang'an Men Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese and Western Medicine
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Hospital of acupuncture-Moxibustion, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijin
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Hebei
country: China
facility: Affiliated Hospital of Hebei University of Chinese Medicine
state: Hebei
city: Tianjin
country: China
facility: First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
affiliation: lcz623780@126.com
name: Cun-Zhi Liu
role: STUDY_CHAIR
References:
citation: Tu JF, Yang JW, Shi GX, Yu ZS, Li JL, Lin LL, Du YZ, Yu XG, Hu H, Liu ZS, Jia CS, Wang LQ, Zhao JJ, Wang J, Wang T, Wang Y, Wang TQ, Zhang N, Zou X, Wang Y, Shao JK, Liu CZ. Efficacy of Intensive Acupuncture Versus Sham Acupuncture in Knee Osteoarthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2021 Mar;73(3):448-458. doi: 10.1002/art.41584. Epub 2021 Jan 15.
citation: Wang Q, Lv H, Sun ZT, Tu JF, Feng YW, Wang TQ, Liu CZ. Effect of Electroacupuncture versus Sham Electroacupuncture in Patients with Knee Osteoarthritis: A Pilot Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 30;2020:1686952. doi: 10.1155/2020/1686952. eCollection 2020.
citation: Tu JF, Yang JW, Wang LQ, Wang Y, Li JL, Zhang N, Lin LL, Yu ZS, Liu CZ. Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial. Trials. 2019 Jul 4;20(1):394. doi: 10.1186/s13063-019-3513-2.
citation: Tu JF, Yang JW, Lin LL, Wang TQ, Du YZ, Liu ZS, Hu H, Zhao JJ, Yu XG, Jia CS, Wang J, Wang T, Hou YQ, Zou X, Wang Y, Shao JK, Wang LQ, Yu ZS, Liu CZ. Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial. Trials. 2019 Jan 25;20(1):79. doi: 10.1186/s13063-018-3138-x.