Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Acupuncture; Sensitive Acupoints; Tender Points
• Intervention / Treatment: Other: acupuncture

Detailed Description

Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.

• Study Type: Interventional
• Enrollment (Actual): 666
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610075
      • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(KOA) are eligible to participate in the study

• The following criteria are used for diagnosis of KOA:

  • refractory knee pain for most days in the last month;
  • joint space narrowing, sclerosis or cystic change in subchondral bone (as demonstrated in X-ray);
  • laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
  • morning stiffness continues less than 30 minutes;
  • bone sound exists when joints was taking flexion and/or extension. If a patient meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is confirmed.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

• diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis;
• present sprain or trauma in the lower limb;
• unable to walk properly due to foot deformity or pain;
• present with mental disorders;
• present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
• females who are pregnant or lactating;
• using physiotherapy treatments for osteoarthritis knee pain;
• have used intra-articular injection of glucocorticoid or viscosupplementation in the past six months;
• received knee-replacement surgery;
• diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic classification) or late clinical stage of KOA;
• have a swollen knee or positive result of floating patella test; or'
• are participating or have participated in the other clinical trials.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture at highly sensitive points; Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points.	Other: acupuncture; a stimulation of the body or auricular points
Active Comparator: acupuncture at lowly/non-sensitive points; Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points.	Other: acupuncture; a stimulation of the body or auricular points
No Intervention: no acupuncture (waiting-list); Patients in the waiting-list group will not receive any acupuncture intervention during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks	It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.	Assessments will be conducted at baseline and 16 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks	It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems, 1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being).	Assessments will be conducted at baseline and 16 weeks after randomization
The changes of knee ranges of motion (ROMs) from baseline to 16 weeks	The knee ROMs will be assessed both actively and passively by using a standard goniometer. It will include flexion, extension, internal rotation and external rotation.	Assessments will be conducted at baseline and 16 weeks after randomization
The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks	The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.	Assessments will be conducted at baseline and 16 weeks after randomization

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: Xin Sun, Phd, West China Hospital

Publications and helpful links

General Publications

• Liu J, Li Y, Li L, Luo X, Li N, Yang X, Zhang H, Liu Z, Kang D, Luo Y, Liu Y, Jia Y, Ren Y, Yao M, Wang Y, Chen J, Maiji M, Zou K, Zhao L, Liang F, Sun X. Effects of acupuncture at acupoints with lower versus higher pain threshold for knee osteoarthritis: a multicenter randomized controlled trial. Chin Med. 2022 Jun 8;17(1):67. doi: 10.1186/s13020-022-00626-3.
• Tang L, Jia P, Zhao L, Kang D, Luo Y, Liu J, Li L, Zheng H, Li Y, Li N, Guyatt G, Sun X. Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial. BMJ Open. 2018 Oct 2;8(10):e023838. doi: 10.1136/bmjopen-2018-023838.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 30, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Hypersensitivity; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 20178159950025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No