Acupuncture Therapy for Knee Osteoarthritis (ATKOA Ⅱ)

December 3, 2017 updated by: Ping Zhou, Beijing Hospital of Traditional Chinese Medicine

Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijin, Beijing, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100000
        • Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
      • Beijing, Beijing, China, 100053
        • Guang'an Men Hospital, China Academy of Chinese Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100078
        • Beijing Hospital of Traditional Chinese and Western Medicine
        • Contact:
      • Beijing, Beijing, China, 100078
        • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
        • Contact:
      • Beijing, Beijing, China, 100700
        • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
        • Contact:
      • Beijing, Beijing, China, 100700
        • Hospital of acupuncture-Moxibustion, China Academy of Chinese Medical Sciences
        • Contact:
    • Hebei
      • Hebei, Hebei, China, 050011
        • Affiliated Hospital of Hebei University of Chinese Medicine
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks, 26 weeks
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.
baseline, 8 weeks, 16 weeks and 26 weeks
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.
baseline, 8 weeks, 16 weeks and 26 weeks
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.
baseline, 8 weeks, 16 weeks and 26 weeks
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.
baseline, 8 weeks, 16 weeks and 26 weeks
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.
baseline, 8 weeks, 16 weeks and 26 weeks
Credibility score
Time Frame: 1 week（after the first treatment）
using Credibility/expectancy questionnaire
1 week（after the first treatment）
Expectancy score
Time Frame: 1 week（after the first treatment）
using Credibility/expectancy questionnaire
1 week（after the first treatment）
Blinding assessment
Time Frame: 4 weeks and 8 weeks
Blinding assessment will be performed in all 9 centers
4 weeks and 8 weeks
Global effect
Time Frame: 8 weeks, 16 weeks and 26 weeks
Overall Treatment Effect (extremely improved, slightly improved, not changed, slightly aggravated, extremely aggravated)
8 weeks, 16 weeks and 26 weeks
Adverse events
Time Frame: first treatment up to 8 weeks
Adverse Event Form
first treatment up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital of Traditional Chinese Medicine

Collaborators

Beijing science and technology commission

Investigators

  • Study Chair: Cun-Zhi Liu, lcz623780@126.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

December 3, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

December 3, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017BL-077-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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