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

NCT ID: NCT03806205

Last Updated: 2019-01-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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regular follow-up

we give a regular follow-up and supervision on the study group

Intervention Type OTHER

Other Intervention Names

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supervision

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianhao Lin, M.D.

Role: STUDY_CHAIR

Peking University People's Hospital

Yudian Qiu, M.D.

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Xicheng District, China

Site Status

Countries

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China

Central Contacts

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Yudian Qiu, M.D.

Role: CONTACT

+8613381150519

Jianhao Lin, M.D.

Role: CONTACT

Facility Contacts

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Yudian Qiu, M.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26997557 (View on PubMed)

Other Identifiers

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PekingUPHmed

Identifier Type: -

Identifier Source: org_study_id

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