Knee OsteoarthristisNCT07326917
Effect of Learning Instruction Package on Patients' Knee Osteoarthritis Outcomes
A study testing Learning Instruction Package in people with Knee Osteoarthristis, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of learning instruction package on patients' knee osteoarthritis outcomes. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Learning Instruction Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Apr 2025
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients.
- Age between 20 and 60 years.
- Clinically diagnosed with knee osteoarthritis.
- Able to communicate and follow instructions.
Who cannot join
- History of any orthopaedic surgical procedure on the affected knee.
- Presence of any physical disability that may interfere with participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Nursing. Mansoura University, Mansoura, Dakahlia 35516
Al Mansurah
About this study
The aim of this study is to evaluate the effect of learning instruction package on patients' knee osteoarthritis outcomes.
Read the detailed description
Musculoskeletal disorders are a group of diseases of the body's motor structures, particularly the bones, joints, muscles, fascia, and other supporting structures such as ligaments and cartilages. In fact, it is estimated that approximately 1.71 billion people are living with a musculoskeletal condition.
Osteoarthritis (OA) is the most common chronic joint disorder, characterized by local inflammation and joint structural change, it is associated with painful symptoms and loss of function leading to considerable impairment of quality of life. The rising rates of disability caused by osteoarthritis highlight the need for implementing preventative measures at early stages of the disease, which would especially benefit subjects at high risk for osteoarthritis development. Several joints are mainly affected by osteoarthritis, especially the knee, hip, hands, feet, shoulders, and spine.
Knee osteoarthritis (KOA) is a common chronic articular disease worldwide. It is also the most common form of osteoarthritis (OA) that affects the entire knee joint and is characterized by high morbidity and disability rates. It is ranked as the 10th largest contributor to global years lived with disabilities, and its prevalence has more than doubled in the last 10 years.
The main clinical symptoms of KOA are limb mobility difficulties, pain and swelling around the joint, which is more obvious after morning, and can lead to paralysis in the later stage. Pain is the key symptom of KOA and the main driver for functional disability and negative impact on different aspects of quality of life (QoL), including mobility, participation, mood and sleep. Patients may experience a serious impact on daily activities due to difficulty in walking, moving, climbing stairs, and while sitting on a chair with weakness of the thigh muscles.
Early diagnosis and treatment of knee osteoarthritis is more beneficial and easily managed compared to when it has worsened. The treatment includes nonpharmacological, pharmacological, and surgical modalities. Learning instruction has been recognized as one of the fundamental components for successful management of knee osteoarthritis, that involve teaching of patients regarding regular exercise, weight management, eating a balanced healthy diet, and applying of local cold or warm compress to improve patient knowledge, developing self-management and life skills.
Nurse plays a vital role in teaching and learning process, and providing valuable information for patients with knee osteoarthritis to improve health outcomes through modifying risk factors for disease progression, preventing further loss of function of the affected joints, relieving pain, improving joint function, optimizing daily living activities, and quality of life.
- Conditions
- Knee Osteoarthristis
- Being tested
- Learning Instruction Package
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning Instruction PackageBehavioural
participants received learning instruction package covered knowledge about knee osteoarthritis; definition, causes, risk factors, pathophysiology, signs, symptoms, and complications, and discussion how to improve knee osteoarthritis outcomes through weight management, diet management, regular exercise, application of compress, and how to apply it properly.
| Study group | Role | What they receive |
|---|---|---|
| learning instruction package for improving Patients' Knee Osteoarthritis Outcomes | Experimental | participants in this group received learning instruction package Receives: Behavioral: Learning Instruction Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Knee Osteoarthritis Outcomes
Assessment of patients' Knee Osteoarthritis Outcomes by using The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
The KOOS's five patient-relevant dimensions were scored separately: Pain (nine items), Symptoms (seven items), ADL Function (seventeen items), Sport and Recreation Function (five items), and Quality of Life (four items).
Measured: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Secondary outcomes (2)
Patients' knowledge regarding knee osteoarthritis questionnaire
Assessment of patients' knowledge about knee osteoarthritis pre \& post learning instruction package.
It included knowledge regarding disease and its management, that consisted of sixteen multiple-choice, closed-ended questions.
Measured: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Body Mass Index (BMI)
BMI= Weight (kg) / Height (m2). It was categorized as follows: below 18.5 is underweight, 18.5- 24.9 is normal or healthy weight, 25- 29.9 is overweight, and 30 and above is obese.
Measured: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Sep 2024
- Primary completion1 Sep 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- A quasi- experimental research design
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gamal Khairy Ali, Mansoura University
- Investigators
- Amany Mohammed Shebl, Professor, Study director, Mansoura UniversityWafaa Ismail Shereif, Professor, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326917
- Sponsor's protocol ID
- Instruction Package on Patient
- Status last verified
- Jun 2025
- First submitted
- 18 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Learning Instruction Package on Patients' Knee Osteoarthritis Outcomes
- ClinicalTrials.gov ID
- NCT07326917
- Acronym / sponsor ID
- Instruction Package on Patient
- Conditions
- Knee Osteoarthristis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 8 Jan 2026 (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.
The aim of this study is to evaluate the effect of learning instruction package on patients' knee osteoarthritis outcomes.
Detailed description
Musculoskeletal disorders are a group of diseases of the body's motor structures, particularly the bones, joints, muscles, fascia, and other supporting structures such as ligaments and cartilages. In fact, it is estimated that approximately 1.71 billion people are living with a musculoskeletal condition.
Osteoarthritis (OA) is the most common chronic joint disorder, characterized by local inflammation and joint structural change, it is associated with painful symptoms and loss of function leading to considerable impairment of quality of life. The rising rates of disability caused by osteoarthritis highlight the need for implementing preventative measures at early stages of the disease, which would especially benefit subjects at high risk for osteoarthritis development. Several joints are mainly affected by osteoarthritis, especially the knee, hip, hands, feet, shoulders, and spine.
Knee osteoarthritis (KOA) is a common chronic articular disease worldwide. It is also the most common form of osteoarthritis (OA) that affects the entire knee joint and is characterized by high morbidity and disability rates. It is ranked as the 10th largest contributor to global years lived with disabilities, and its prevalence has more than doubled in the last 10 years.
The main clinical symptoms of KOA are limb mobility difficulties, pain and swelling around the joint, which is more obvious after morning, and can lead to paralysis in the later stage. Pain is the key symptom of KOA and the main driver for functional disability and negative impact on different aspects of quality of life (QoL), including mobility, participation, mood and sleep. Patients may experience a serious impact on daily activities due to difficulty in walking, moving, climbing stairs, and while sitting on a chair with weakness of the thigh muscles.
Early diagnosis and treatment of knee osteoarthritis is more beneficial and easily managed compared to when it has worsened. The treatment includes nonpharmacological, pharmacological, and surgical modalities. Learning instruction has been recognized as one of the fundamental components for successful management of knee osteoarthritis, that involve teaching of patients regarding regular exercise, weight management, eating a balanced healthy diet, and applying of local cold or warm compress to improve patient knowledge, developing self-management and life skills.
Nurse plays a vital role in teaching and learning process, and providing valuable information for patients with knee osteoarthritis to improve health outcomes through modifying risk factors for disease progression, preventing further loss of function of the affected joints, relieving pain, improving joint function, optimizing daily living activities, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi- experimental research design
| Arm | Type | Receives |
|---|---|---|
| learning instruction package for improving Patients' Knee Osteoarthritis Outcomes | Experimental | Behavioral: Learning Instruction Packageparticipants in this group received learning instruction package |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female patients.
- Age between 20 and 60 years.
- Clinically diagnosed with knee osteoarthritis.
- Able to communicate and follow instructions.
Key exclusion criteria (2 listed)
- History of any orthopaedic surgical procedure on the affected knee.
- Presence of any physical disability that may interfere with participation.
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 |
|---|---|---|
| Learning Instruction Packageparticipants received learning instruction package covered knowledge about knee osteoarthritis; definition, causes, risk factors, pathophysiology, signs, symptoms, and complications, and discussion how to improve knee osteoarthritis outcomes through weight management, diet management, regular exercise, application of compress, and how to apply it properly. | Behavioural | learning instruction package for improving Patients' Knee Osteoarthritis Outcomes |
Primary outcome
Patients' Knee Osteoarthritis Outcomes
Time frame: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Assessment of patients' Knee Osteoarthritis Outcomes by using The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. The KOOS's five patient-relevant dimensions were scored separately: Pain (nine items), Symptoms (seven items), ADL Function (seventeen items), Sport and Recreation Function (five items), and Quality of Life (four items).
2 secondary outcomes
Patients' knowledge regarding knee osteoarthritis questionnaire
Time frame: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Body Mass Index (BMI)
Time frame: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Amany Mohammed Shebl, Professor study director
Mansoura University
Wafaa Ismail Shereif, Professor study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning Instruction Package in people with Knee Osteoarthristis, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jan 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Knee Osteoarthritis Outcomes (time frame: Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.). 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 8 Jan 2026.