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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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