Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acupuncture, Knee Osteoarthritis, Sensitive Acupoints, Tender Points

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture at highly sensitive points<br>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<br>* a stimulation of the body or auricular points<br>|
| Active Comparator: acupuncture at lowly/non-sensitive points<br>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<br>* a stimulation of the body or auricular points<br>|
| No Intervention: no acupuncture (waiting-list)<br>Patients in the waiting-list group will not receive any acupuncture intervention during the study. | |

What is the study measuring?
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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 |