OsteoarthritisNCT05844319
Pain Management In Knee Osteoarthritis
A study testing tele-education in people with Osteoarthritis and Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to investigate the effect of pain management education in individuals with knee osteoarthritis with chronic pain. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee Osteoarthritis, Pain, Chronic
- What is being tested?
- tele-education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tugba Civi Karaaslan
Istanbul, Buyukcekmece
TUGBA CIVI KARAASLAN, PhD, tugba.civi@istanbul.edu.tr
MEHMET YAZGAN, BSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee Osteoarthritis, Pain, Chronic
- Being tested
- tele-education
- Keywords
- Osteoarthritis, Pain Management, Activities of Daily Living, Quality of Life, Tele-education
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-educationOther
The treatment of the patients will be carried out by tele-education method.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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 Receives: Other: tele-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on the first day and eighth week change
Secondary outcomes (2)
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.
Measured: on the first day and eighth week change
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.
Measured: on the first day and eighth week change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
- Investigators
- MEHMET YAZGAN, BSc, Study director, Istanbul University - CerrahpasaMELIKE KARAVUL, BSc, Principal investigator, Istanbul University - CerrahpasaHUSEYIN BAYBAS, BSc, Principal investigator, Istanbul University - CerrahpasaELA TARAKCI, Prof, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844319
- Sponsor's protocol ID
- ISTANBULC4
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PAIN MANAGEMENT TRAINING ON ACTIVITIES OF DAILY LIVING AND QUALITY OF LIFE IN KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT05844319
- Acronym / sponsor ID
- ISTANBULC4
- Conditions
- Osteoarthritis, Knee Osteoarthritis, Pain, Chronic
- Keywords
- Osteoarthritis, Pain Management, Activities of Daily Living, Quality of Life, Tele-education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: tele-educationFollowing 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 |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tele-educationThe treatment of the patients will be carried out by tele-education method. | Other | intervention |
Primary outcome
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.
2 secondary outcomes
The McGill Pain Questionnaire
Time frame: on the first day and eighth week change
Short Form-12
Time frame: on the first day and eighth week change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEHMET YAZGAN, BSc study director
Istanbul University - Cerrahpasa
MELIKE KARAVUL, BSc principal investigator
Istanbul University - Cerrahpasa
HUSEYIN BAYBAS, BSc principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-education in people with Osteoarthritis and Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TUGBA CIVI KARAASLAN, PhD (05343855606, tugba.civi@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: on the first day and eighth week change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.