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

Primary Purpose

To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
regular follow-up
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence focused on measuring Knee osteoarthritis pain; Adherence; Diclofenac; Follow up

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University People's Hospital

Outcomes

Primary Outcome Measures

adherence
We will calculate adherence with medication use
pain relief rate
We will calculate the pain relief rate on all participants

Secondary Outcome Measures

womac score
We will calculate the womac score on all participants

Full Information

First Posted
January 14, 2019
Last Updated
January 14, 2019
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03806205
Brief Title
Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain
Official Title
Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
March 10, 2019 (Anticipated)
Study Completion Date
March 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence
Keywords
Knee osteoarthritis pain; Adherence; Diclofenac; Follow up

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
regular follow-up
Other Intervention Name(s)
supervision
Intervention Description
we give a regular follow-up and supervision on the study group
Primary Outcome Measure Information:
Title
adherence
Description
We will calculate adherence with medication use
Time Frame
6-8 weeks
Title
pain relief rate
Description
We will calculate the pain relief rate on all participants
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
womac score
Description
We will calculate the womac score on all participants
Time Frame
6-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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. Repeated knee pain in the past month X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin. Joint fluid (> 2 times) is cool and sticky, WBC < 2000/ml Age over 40 Morning stiffness less than 30 minutes 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yudian Qiu, M.D.
Phone
+8613381150519
Email
1210301417@pku.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhao Lin, M.D.
Email
linjianhao@pkuph.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhao Lin, M.D.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yudian Qiu, M.D.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Xicheng District
ZIP/Postal Code
100044
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yudian Qiu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26997557
Citation
da Costa BR, Reichenbach S, Keller N, Nartey L, Wandel S, Juni P, Trelle S. RETRACTED: Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016 May 21;387(10033):2093-2105. doi: 10.1016/S0140-6736(16)30002-2. Epub 2016 Mar 18.
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Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

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