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Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

Primary Purpose

Acupuncture, Knee Osteoarthritis, Sensitive Acupoints

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
  • Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
  • the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

acupuncture at highly sensitive points

acupuncture at lowly/non-sensitive points

no acupuncture (waiting-list)

Arm Description

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.

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.

Patients in the waiting-list group will not receive any acupuncture intervention during the study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
September 27, 2017
Last Updated
December 21, 2021
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03299439
Brief Title
Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
Official Title
A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Knee Osteoarthritis, Sensitive Acupoints, Tender Points

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture at highly sensitive points
Arm Type
Experimental
Arm Description
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.
Arm Title
acupuncture at lowly/non-sensitive points
Arm Type
Active Comparator
Arm Description
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.
Arm Title
no acupuncture (waiting-list)
Arm Type
No Intervention
Arm Description
Patients in the waiting-list group will not receive any acupuncture intervention during the study.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
a stimulation of the body or auricular points
Primary Outcome Measure Information:
Title
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
Description
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.
Time Frame
Assessments will be conducted at baseline and 16 weeks after randomization
Secondary Outcome Measure Information:
Title
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
Description
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).
Time Frame
Assessments will be conducted at baseline and 16 weeks after randomization
Title
The changes of knee ranges of motion (ROMs) from baseline to 16 weeks
Description
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.
Time Frame
Assessments will be conducted at baseline and 16 weeks after randomization
Title
The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks
Description
The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.
Time Frame
Assessments will be conducted at baseline and 16 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Sun, Phd
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35676697
Citation
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.
Results Reference
derived
PubMed Identifier
30282686
Citation
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.
Results Reference
derived

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Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

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