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

NCT03806205 | Unknown

• 1 other identifier: PekingUPHmed
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• adherence

  We will calculate adherence with medication use

  6-8 weeks

• pain relief rate

  We will calculate the pain relief rate on all participants

  6-8 weeks

Secondary Outcomes (1)

• womac score

  6-8 weeks

Interventions

regular follow-up OTHER

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

Also known as: supervision

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Xicheng District, 100044, China

Location

Related Publications (1)

• 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.

  PMID: 26997557 BACKGROUND

MeSH Terms

Interventions

Organization and Administration

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Jianhao Lin, M.D.

  Peking University People's Hospital

  STUDY CHAIR

• Yudian Qiu, M.D.

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yudian Qiu, M.D.

CONTACT

+8613381150519; 1210301417@pku.edu.cn

Jianhao Lin, M.D.

CONTACT

linjianhao@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: January 15, 2019
• Primary Completion: March 10, 2019
• Study Completion: March 15, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

CN (1)