A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints

Study Overview
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Brief Summary
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The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.

Detailed Description
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Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.

Official Title
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Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial

Conditions
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Acupuncture, Knee Osteoarthritis, Randomized Controlled Trial

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent. The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis: refractory knee pain for most days in the last month; joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray); laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3; age 40 years or older; morning stiffness continues less than 30 minutes; bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6). Exclusion Criteria: Patients will be excluded if they: Can not adhere to the study protocol in the future 6 months; Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis; Have sprain or other trauma; Are unable to walk properly due to foot deformity or pain; Are present with mental disorders; Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder; Females who are pregnant or lactating; Were using physiotherapy treatments for osteoarthritis knee pain; Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; Received knee-replacement surgery; Were participating or had 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: experimental group: Acupuncture<br>acupuncture on 5 most sensitized points/ acupoints | Other: acupuncture<br>* a stimulation of the body or auricular points<br>|
| Active Comparator: Control group: Acupuncture<br>acupuncture on 5 least low/non-sensitized points | Other: acupuncture<br>* a stimulation of the body or auricular points<br>|

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 |