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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-31

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.

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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.

Conditions

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Acupuncture Knee Osteoarthritis Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental group: Acupuncture

acupuncture on 5 most sensitized points/ acupoints

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

a stimulation of the body or auricular points

Control group: Acupuncture

acupuncture on 5 least low/non-sensitized points

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

a stimulation of the body or auricular points

Interventions

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acupuncture

a stimulation of the body or auricular points

Intervention Type OTHER

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No