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Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

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: NCT03806205
Recruitment Status : Unknown
Verified January 2019 by Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

Study Description
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Brief Summary:
To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.

Condition or disease Intervention/treatment Phase
To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence Other: regular follow-up Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : March 10, 2019
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Diclofenac

Arms and Interventions
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Intervention Details:
  • Other: regular follow-up
    we give a regular follow-up and supervision on the study group
    Other Name: supervision

Outcome Measures
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Primary Outcome Measures :
  1. adherence [ Time Frame: 6-8 weeks ]
    We will calculate adherence with medication use

  2. pain relief rate [ Time Frame: 6-8 weeks ]
    We will calculate the pain relief rate on all participants


Secondary Outcome Measures :
  1. womac score [ Time Frame: 6-8 weeks ]
    We will calculate the womac score on all participants


Eligibility Criteria
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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:

  • According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria.

    1. Repeated knee pain in the past month
    2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin.
    3. Joint fluid (> 2 times) is cool and sticky, WBC < 2000/ml
    4. Age over 40
    5. Morning stiffness less than 30 minutes
    6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed.
    7. The informed consent has been signed

Exclusion Criteria:

  • (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study
Contacts and Locations
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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): NCT03806205


Contacts
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Contact: Yudian Qiu, M.D. +8613381150519 1210301417@pku.edu.cn
Contact: Jianhao Lin, M.D. linjianhao@pkuph.edu.cn

Locations
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China, Xicheng District
Peking University People's Hospital
Beijing, Xicheng District, China, 100044
Contact: Yudian Qiu, M.D.         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Chair: Jianhao Lin, M.D. Peking University People's Hospital
Study Director: Yudian Qiu, M.D. Peking University People's Hospital
More Information
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Publications:

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03806205    
Other Study ID Numbers: PekingUPHmed
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
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
Keywords provided by Peking University People's Hospital:
Knee osteoarthritis pain; Adherence; Diclofenac; Follow up
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases