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Pain Management In Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee Osteoarthritis, Pain, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
tele-education
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Pain Management, Activities of Daily Living, Quality of Life, Tele-education

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tugba Civi Karaaslan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

Following the completion of the evaluations of the cases, the following 6-step program will be applied to cope with the pain: Informative education about the disease Teaching relaxation positions for pain management Relaxation exercises with breathing exercises Training on ergonomic approaches in daily life (correct sitting, lying, working, carrying, etc.) Education of principles of joint protection Creating and training a personalized physical activity and exercise plan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 25, 2023
Last Updated
May 4, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05844319
Brief Title
Pain Management In Knee Osteoarthritis
Official Title
THE EFFECT OF PAIN MANAGEMENT TRAINING ON ACTIVITIES OF DAILY LIVING AND QUALITY OF LIFE IN KNEE OSTEOARTHRITIS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee Osteoarthritis, Pain, Chronic
Keywords
Osteoarthritis, Pain Management, Activities of Daily Living, Quality of Life, Tele-education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
Following the completion of the evaluations of the cases, the following 6-step program will be applied to cope with the pain: Informative education about the disease Teaching relaxation positions for pain management Relaxation exercises with breathing exercises Training on ergonomic approaches in daily life (correct sitting, lying, working, carrying, etc.) Education of principles of joint protection Creating and training a personalized physical activity and exercise plan
Intervention Type
Other
Intervention Name(s)
tele-education
Intervention Description
The treatment of the patients will be carried out by tele-education method.
Primary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
on the first day and eighth week change
Secondary Outcome Measure Information:
Title
The McGill Pain Questionnaire
Description
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.
Time Frame
on the first day and eighth week change
Title
Short Form-12
Description
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.
Time Frame
on the first day and eighth week change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TUGBA CIVI KARAASLAN, PhD
Phone
05343855606
Email
tugba.civi@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MEHMET YAZGAN, BSc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
MELIKE KARAVUL, BSc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HUSEYIN BAYBAS, BSc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ELA TARAKCI, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Tugba Civi Karaaslan
City
Istanbul
State/Province
Buyukcekmece
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TUGBA CIVI KARAASLAN, PhD
Email
tugba.civi@istanbul.edu.tr
First Name & Middle Initial & Last Name & Degree
MEHMET YAZGAN, BSc
First Name & Middle Initial & Last Name & Degree
MELIKE KARAVUL, BSc
First Name & Middle Initial & Last Name & Degree
HUSEYIN BAYBAS, BSc
First Name & Middle Initial & Last Name & Degree
ELA TARAKCI, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Management In Knee Osteoarthritis

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