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Acupuncture Therapy for Knee Osteoarthritis (ATKOA Ⅱ)

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ClinicalTrials.gov Identifier: NCT03366363
Recruitment Status : Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Beijing science and technology commission
Information provided by (Responsible Party):
Ping Zhou, Beijing Hospital of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Acupuncturist (Electro-acupuncture group and Manual acupuncture group), Participant, Outcome Assessor
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electro-acupuncture
5 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.
Other: acupuncture
acupuncture is a therapy of traditional Chinese medicine,in which acupuncturist puncture the patient's skin at specific acupoints with needle.

Experimental: manual acupuncture
Participants 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.
Other: acupuncture
acupuncture is a therapy of traditional Chinese medicine,in which acupuncturist puncture the patient's skin at specific acupoints with needle.

Sham Comparator: sham acupuncture
Those in the sham acupuncture group receive shallow acupuncture at non-acupoints without manipulation,Deqi or actual current output.
Other: acupuncture
acupuncture is a therapy of traditional Chinese medicine,in which acupuncturist puncture the patient's skin at specific acupoints with needle.




Primary Outcome Measures :
  1. Response rate [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 16 weeks, 26 weeks ]
    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 16 and 26 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.

  2. Knee-joint pain [ Time Frame: baseline, 8 weeks, 16 weeks and 26 weeks ]
    using numerical rating scale (NRS). 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.

  3. Knee-joint pain [ Time Frame: baseline, 8 weeks, 16 weeks and 26 weeks ]
    using WOMAC pain subscale. 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.

  4. Knee-joint function [ Time Frame: baseline, 8 weeks, 16 weeks and 26 weeks ]
    using WOMAC function subscale. 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.

  5. Knee-joint stiffness [ Time Frame: baseline, 8 weeks, 16 weeks and 26 weeks ]
    using WOMAC stiffness subscale. 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.

  6. Quality of life [ Time Frame: baseline, 8 weeks, 16 weeks and 26 weeks ]
    using 12-Item Short Form Health Survey. An overall score range of 0 (minimum) to 100(maximum), with higher scores indicating better quality of life.

  7. Credibility score [ Time Frame: 1 week(after the first treatment) ]
    using Credibility/expectancy questionnaire

  8. Expectancy score [ Time Frame: 1 week(after the first treatment) ]
    using Credibility/expectancy questionnaire

  9. Blinding assessment [ Time Frame: 4 weeks and 8 weeks ]
    Blinding assessment will be performed in all 9 centers

  10. Global effect [ Time Frame: 8 weeks, 16 weeks and 26 weeks ]
    Overall Treatment Effect (extremely improved, slightly improved, not changed, slightly aggravated, extremely aggravated)

  11. Adverse events [ Time Frame: first treatment up to 8 weeks ]
    Adverse Event Form



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366363


Contacts
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Contact: Cun-Zhi Liu 0086-10-52176043 lcz623780@126.com
Contact: Jian-Feng Tu tujianfeng1@126.com

Locations
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China, Beijing
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing, China, 100000
Guang'an Men Hospital, China Academy of Chinese Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100053
Contact: Zhi-Shun Liu       liuzhishun@aliyun.com   
Beijing Hospital of Traditional Chinese and Western Medicine Not yet recruiting
Beijing, Beijing, China, 100078
Contact: Xiao-Gang Yu       yuxiaogang6451@163.com   
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine Not yet recruiting
Beijing, Beijing, China, 100078
Contact: Hui Hu       dfzhenjiu@126.com   
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Not yet recruiting
Beijing, Beijing, China, 100700
Contact: Jun Wang       wangjunee@yeah.net   
Hospital of acupuncture-Moxibustion, China Academy of Chinese Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100700
Contact: Hong Zhao       hongzhao2005@aliyun.com   
Beijing Friendship Hospital, Capital Medical University Not yet recruiting
Beijin, Beijing, China, 100050
Contact: Jing-Jie Zhao       13466376389@139.com   
China, Hebei
Affiliated Hospital of Hebei University of Chinese Medicine Not yet recruiting
Hebei, Hebei, China, 050011
Contact: Chun-Sheng Jia       jia7158@163.com   
China, Tianjin
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Not yet recruiting
Tianjin, Tianjin, China, 300193
Contact: Yu-Zheng Du       drduyuzheng@163.com   
Sponsors and Collaborators
Beijing Hospital of Traditional Chinese Medicine
Beijing science and technology commission
Investigators
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Study Chair: Cun-Zhi Liu lcz623780@126.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ping Zhou, Clinical Professor, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03366363     History of Changes
Other Study ID Numbers: 2017BL-077-01
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ping Zhou, Beijing Hospital of Traditional Chinese Medicine:
Knee osteoarthritis
acupuncture
electroacupuncture
sham acupuncture

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases