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

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03806205
• Other study ID #: PekingUPHmed
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 15, 2019

Study information

• Verified date: January 2019
• Source: Peking University People's Hospital
• Contact: Yudian Qiu, M.D.
• Phone: +8613381150519
• Email: 1210301417[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 15, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Xicheng District

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

da Costa BR, Reichenbach S, Keller N, Nartey L, Wandel S, Jüni 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. Retraction in: Lancet. 2017 Jul 8;390(10090):109. Corrected and republished in: Lancet. 2017 Jul 8;390(10090):e21-e33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence	We will calculate adherence with medication use	6-8 weeks
Primary	pain relief rate	We will calculate the pain relief rate on all participants	6-8 weeks
Secondary	womac score	We will calculate the womac score on all participants	6-8 weeks