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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05844319
Other study ID # ISTANBULC4
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2024

Study information

Verified date May 2023
Source Istanbul University
Contact TUGBA CIVI KARAASLAN, PhD
Phone 05343855606
Email tugba.civi@istanbul.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it was aimed to investigate the effect of pain management education in individuals with knee osteoarthritis with chronic pain.


Description:

Knee osteoarthritis (OA), also known as degenerative joint disease of the knee, is typically the result of wear and tear and progressive loss of joint cartilage. Knee osteoarthritis can be divided into two types, primary and secondary. It is most common in the elderly. The intensity of clinical symptoms can vary from person to person. However, they typically become more severe, more frequent, and more debilitating over time. The rate of progression also varies with each individual. People suffering from knee osteoarthritis complain of limited range of motion and pain when they move their knee or start walking. In advanced disease, they may complain of nocturnal or persistent knee pain and the functionality of the joint is severely impaired. Knee osteoarthritis treatment begins with non-surgical (conservative) treatment methods. Non-surgical treatment includes patient education, lifestyle modification, and the use of orthotic devices. It has been shown that untreated pain in the elderly can have a general impact on their quality of life and lead to depression, anxiety, social isolation, cognitive impairment, inactivity, and sleep disorders. The aim of our project is to provide training for patients diagnosed with knee osteoarthritis with chronic pain to be able to control their pain with self-management and to perform activities of daily living more easily. Appropriate knowledge and awareness can improve their quality of life. Performing safe and accurate pain management practices in the elderly can improve their performance, quality of life, increase their comfort and reduce their care costs. In this study, it was aimed to investigate the effect of pain management education in individuals with knee osteoarthritis with chronic pain.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date May 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - To be diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR) - Be between 45 and 75 years old - Stage 2-3 according to Kellgren Lawrence (K-L) in the radiological examination Exclusion Criteria: - Having active synovitis - Receiving physical therapy in the last 6 months - People with neurological problems that affect walking - Those with arthritis in the ankle and hip joint - Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise. - Have had surgery on the lower extremity in the past - Intra-articular steroid injections in the last 6 months - Use of psychoactive drugs

Study Design


Intervention

Other:
tele-education
The treatment of the patients will be carried out by tele-education method.

Locations

Country Name City State
Turkey Tugba Civi Karaaslan Istanbul Buyukcekmece

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) We will use the Knee Injury and Osteoarthritis Outcome Score (KOOS) in order not to exceed the pain and daily life span of our patients. It is a scale that evaluates the functional status and groups related to knee injuries and knee osteoarthritis. Other definition of pain has 5 subgroups, including functional status related to daily life span, functional status in sports and leisure activities, and sequence-related quality of life. It consists of 42 questions lasting approximately 10 minutes. Each subscale is scored between 0-100. 0 indicates serious problem, 100 indicates no problem. A score of 10 and above indicates that it changes clinically. on the first day and eighth week change
Secondary The McGill Pain Questionnaire We will use the McGill Pain Questionnaire to evaluate the pain status of our patients. The McGill Pain Questionnaire is a chart with descriptive words about pain. Words are normally divided into four main categories: sensory, emotional, evaluative, and miscellaneous. Within these categories are specific subcategories that contain words used to describe the intensity of a particular sensation or emotional response. Following a particular method, patients choose the most appropriate words from each category to describe their pain to their doctor as precisely and precisely as possible. This can lead to better pain management and, in some cases, better and faster diagnosis. The most common version has 20 subcategories of descriptive words. on the first day and eighth week change
Secondary Short Form-12 Similar to SF-36, SF-12 has physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item) It consists of 8 sub-dimensions and 12 items: emotional role (2 items) and mental health (2 items). Items related to physical and emotional role were answered as dichotomy (yes or no), while other items had Likert type options ranging between 3 and 6. on the first day and eighth week change
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