Pain Management In Knee Osteoarthritis

May 4, 2023 updated by: Tugba Civi Karaaslan, Istanbul University

THE EFFECT OF PAIN MANAGEMENT TRAINING ON ACTIVITIES OF DAILY LIVING AND QUALITY OF LIFE IN KNEE OSTEOARTHRITIS

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Buyukcekmece
      • Istanbul, Buyukcekmece, Turkey
        • Tugba Civi Karaaslan
        • Contact:
        • Sub-Investigator:
          • MEHMET YAZGAN, BSc
        • Sub-Investigator:
          • MELIKE KARAVUL, BSc
        • Sub-Investigator:
          • HUSEYIN BAYBAS, BSc
        • Principal Investigator:
          • ELA TARAKCI, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention

Following the completion of the evaluations of the cases, the following 6-step program will be applied to cope with the pain:

  1. Informative education about the disease
  2. Teaching relaxation positions for pain management
  3. Relaxation exercises with breathing exercises
  4. Training on ergonomic approaches in daily life (correct sitting, lying, working, carrying, etc.)
  5. Education of principles of joint protection
  6. Creating and training a personalized physical activity and exercise plan
Other: tele-education
The treatment of the patients will be carried out by tele-education method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: on the first day and eighth week change
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The McGill Pain Questionnaire
Time Frame: on the first day and eighth week change
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
Short Form-12
Time Frame: on the first day and eighth week change
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: MEHMET YAZGAN, BSc, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: MELIKE KARAVUL, BSc, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: HUSEYIN BAYBAS, BSc, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: ELA TARAKCI, Prof, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISTANBULC4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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