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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03806205
Enrollment
120
Registered
2019-01-16
Start date
2019-01-15
Completion date
2019-03-15
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
adherence6-8 weeksWe will calculate adherence with medication use
pain relief rate6-8 weeksWe will calculate the pain relief rate on all participants

Secondary

MeasureTime frameDescription
womac score6-8 weeksWe will calculate the womac score on all participants

Countries

China

Contacts

Primary ContactYudian Qiu, M.D.
1210301417@pku.edu.cn+8613381150519
Backup ContactJianhao Lin, M.D.
linjianhao@pkuph.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026