Pain Management In Knee Osteoarthritis

Sponsor
Istanbul University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05844319
Collaborator
(none)
25
1
1
12
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: tele-education
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
THE EFFECT OF PAIN MANAGEMENT TRAINING ON ACTIVITIES OF DAILY LIVING AND QUALITY OF LIFE IN KNEE OSTEOARTHRITIS
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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: 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

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

Outcome Measures

Primary Outcome Measures

  1. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [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.

Secondary Outcome Measures

  1. The McGill Pain Questionnaire [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.

  2. Short Form-12 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tugba Civi Karaaslan Istanbul Buyukcekmece Turkey

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tugba Civi Karaaslan, Research Assistant, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05844319
Other Study ID Numbers:
  • ISTANBULC4
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tugba Civi Karaaslan, Research Assistant, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023