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Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299439
Recruitment Status : Unknown
Verified September 2017 by Sun Xin, West China Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Sun Xin, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Acupuncture Knee Osteoarthritis Sensitive Acupoints Tender Points Other: acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
Estimated Study Start Date : October 20, 2017
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture at highly sensitive points Other: acupuncture
a stimulation of the body or auricular points

Active Comparator: acupuncture at lowly/non-sensitive points Other: acupuncture
a stimulation of the body or auricular points

No Intervention: no acupuncture (waiting-list)



Primary Outcome Measures :
  1. The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks [ Time Frame: Assessments will be conducted at baseline and 16 weeks after randomization ]
    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 :
  1. The change of Short Form (SF)-12 health survey score from baseline to 16 weeks [ Time Frame: Assessments will be conducted at baseline and 16 weeks after randomization ]
    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).

  2. The changes of knee ranges of motion (ROMs) from baseline to 16 weeks [ Time Frame: Assessments will be conducted at baseline and 16 weeks after randomization ]
    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.

  3. The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks [ Time Frame: Assessments will be conducted at baseline and 16 weeks after randomization ]
    The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299439


Contacts
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Contact: Xin Sun, Phd 86-18980606047 sunx79@hotmail.com

Sponsors and Collaborators
West China Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sun Xin, Director, West China Hospital
ClinicalTrials.gov Identifier: NCT03299439    
Other Study ID Numbers: 20178159950025
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Hypersensitivity
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Immune System Diseases