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Acupuncture Therapy for Knee Osteoarthritis (ATKOA Ⅱ)

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ClinicalTrials.gov Identifier: NCT03366363
Recruitment Status : Unknown
Verified December 2017 by Ping Zhou, Beijing Hospital of Traditional Chinese Medicine.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE December 8, 2017
Last Update Posted Date December 8, 2017
Estimated Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Credibility score [ Time Frame: 1 week(after the first treatment) ]
    using Credibility/expectancy questionnaire
  • Expectancy score [ Time Frame: 1 week(after the first treatment) ]
    using Credibility/expectancy questionnaire
  • Blinding assessment [ Time Frame: 4 weeks and 8 weeks ]
    Blinding assessment will be performed in all 9 centers
  • Global effect [ Time Frame: 8 weeks, 16 weeks and 26 weeks ]
    Overall Treatment Effect (extremely improved, slightly improved, not changed, slightly aggravated, extremely aggravated)
  • Adverse events [ Time Frame: first treatment up to 8 weeks ]
    Adverse Event Form
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture Therapy for Knee Osteoarthritis
Official Title  ICMJE Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Other: acupuncture
acupuncture is a therapy of traditional Chinese medicine,in which acupuncturist puncture the patient's skin at specific acupoints with needle.
Study Arms  ICMJE
  • 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.
    Intervention: Other: acupuncture
  • 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.
    Intervention: Other: acupuncture
  • Sham Comparator: sham acupuncture
    Those in the sham acupuncture group receive shallow acupuncture at non-acupoints without manipulation,Deqi or actual current output.
    Intervention: Other: acupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2017)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03366363
Other Study ID Numbers  ICMJE 2017BL-077-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ping Zhou, Beijing Hospital of Traditional Chinese Medicine
Study Sponsor  ICMJE Beijing Hospital of Traditional Chinese Medicine
Collaborators  ICMJE Beijing science and technology commission
Investigators  ICMJE
Study Chair: Cun-Zhi Liu lcz623780@126.com
PRS Account Beijing Hospital of Traditional Chinese Medicine
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP