Acupuncture Therapy for Knee Osteoarthritis
ATKOA Ⅱ
Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial
1 other identifier
interventional
480
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Dec 2017
Typical duration for not_applicable knee-osteoarthritis
9 active sites
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
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedDecember 8, 2017
December 1, 2017
1 year
November 20, 2017
December 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 8 weeks. Pain NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. 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.
8 weeks
Secondary Outcomes (11)
Response rate
16 weeks, 26 weeks
Knee-joint pain
baseline, 8 weeks, 16 weeks and 26 weeks
Knee-joint pain
baseline, 8 weeks, 16 weeks and 26 weeks
Knee-joint function
baseline, 8 weeks, 16 weeks and 26 weeks
Knee-joint stiffness
baseline, 8 weeks, 16 weeks and 26 weeks
- +6 more secondary outcomes
Study Arms (3)
Electro-acupuncture
EXPERIMENTAL5 compulsory acupoints (ST35、EX-LE5、LR8、GB33 and Ashi) and 3 optional matching acupoints (stomach meridian syndrome：ST34、ST36、ST32、ST40、EX-LE2；gallbladder meridian syndrome：GB31、GB36、GB34、GB39、GB41；bladder meridian syndrome：BL39、BL40、BL57、BL60；San Yin meridian syndrome：LR7、SP9、SP10、KI10、SP4、SP6、LR3、KI3) will be chosen. Needles will be stimulated manually to achieve "De Qi" sensation and an electrical apparatus (Nanjing Jisheng Medical Co., Ltd., wave of 2/100Hz) will be then connected to the needles with alligator clips in pairs LR8-GB33 and two other matching acupoints. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity. Patients will receive 30-minute, 24 sessions intervention over eight weeks.
manual acupuncture
EXPERIMENTALParticipants in the manual acupuncture group have the same schedule as the Electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output.
sham acupuncture
SHAM COMPARATORThose in the sham acupuncture group receive shallow acupuncture at non-acupoints without manipulation，Deqi or actual current output.
Interventions
acupuncture is a therapy of traditional Chinese medicine，in which acupuncturist puncture the patient's skin at specific acupoints with needle.
Eligibility Criteria
You may qualify if:
- Age 45-75 years old, male or female
- Single / bilateral knee pain, duration of more than 6 months
- KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ
- NRS ≥ 4
You may not qualify if:
- Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
- 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.)
- History of arthroscopy within 1 year or intra-articular injection within 4 months
- History of receiving acupuncture or massage treatment within 3 months
- Severe acute/chronic organic or mental diseases
- Coagulation disorders (such as hemophilia, etc.)
- Cardiac pacemaker, metal allergy or needle phobia
- Pregnant women, pregnant and lactating women
- Participation in another clinical study in the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing Municipality, 100000, China
Guang'an Men Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Beijing Hospital of Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, 100078, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700, China
Hospital of acupuncture-Moxibustion, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700, China
Beijing Friendship Hospital, Capital Medical University
Beijin, Beijing Municipality, 100050, China
Affiliated Hospital of Hebei University of Chinese Medicine
Hebei, Hebei, 050011, China
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193, China
Related Publications (5)
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.
PMID: 33174383DERIVEDWang 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.
PMID: 32802114DERIVEDTu 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.
PMID: 31272488DERIVEDTu 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. Correction to: Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial. Trials. 2019 Apr 10;20(1):204. doi: 10.1186/s13063-019-3338-z.
PMID: 30971318DERIVEDTu 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.
PMID: 30683147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cun-Zhi Liu
lcz623780@126.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Acupuncturist (Electro-acupuncture group and Manual acupuncture group), Participant, Outcome Assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 20, 2017
First Posted
December 8, 2017
Study Start
December 15, 2017
Primary Completion
December 31, 2018
Study Completion
June 30, 2019
Last Updated
December 8, 2017
Record last verified: 2017-12