Osteo Arthritis KneeNCT05649995
Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis
A study testing Pain science education driven physiotherapy program and Biomedical education driven physiotherapy program in people with Osteo Arthritis Knee, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effectiveness of the program integrated with pain science education for people with painful knee osteoarthritis (OA). Another purpose of the study is to evaluate whether the program integrated with pain science education is more effective than the program integrated with… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Pain science education driven physiotherapy program and Biomedical education driven physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 1 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with knee osteoarthritis according to the criteria of the American College of Rheumatology (ACR).
- Being between the ages of 45-65
- Having knee pain lasting at least 6 months
- Average knee pain intensity of ≥4 on 11- point numeric rating scale in the past week
- Having Turkish as mother tongue
- Being literate
Who cannot join
- Having health problems (eg heart or lung disease) that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines.
- Neurological disorders affecting the lower extremity (eg multiple sclerosis or stroke)
- Using an assistive device
- Being diagnosed with OA in joint areas other than the knee joint
- Presence of inflammatory arthritis (including rheumatoid arthritis)
- Presence of any condition that affects decision making/memory (eg Alzheimer's, dementia)
- Knee replacement/surgery planning for the next 3 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University
Istanbul, Maltepe
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official title: Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis: A Randomized Controlled Study
The aim of this study is to determine the effectiveness of the program integrated with pain science education for people with painful knee osteoarthritis (OA). Another purpose of the study is to evaluate whether the program integrated with pain science education is more effective than the program integrated with biomedical education.
Read the detailed description
Contemporary pain science education provides a scientific basis for the increased sensitivity produced in chronic pain due to adaptations in the central nervous system. In the literature, pain science education has been shown to reduce unhelpful pain beliefs and improve pain, function, and disability in several chronic musculoskeletal pain states, but data specific to knee OA are lacking.
Patients with knee osteoarthritis who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into two groups. These groups are: a) intervention group, where the program integrated with pain science education and b)control group, where the program integrated with biomedical education.
Three weeks of face-to-face sessions in both groups will be followed by three weeks of telerehabilitation sessions. Telerehabilitation sessions will be applied as phone calls or video conference sessions, according to the participant's request. All sessions will be conducted one-on-one.
Face-to-face sessions for both groups:
- 3 sessions in total,
- 1 day a week for 3 weeks,
- Each session will last approximately 60 minutes for the control group and the intervention group.
- Each face-to-face session will include education and physiotherapy program. Biomedical education for the control group and pain science education for the intervention group will be applied. Visuals and presentations will be used in the education of both groups. The presentations and visuals that will be used in pain science education and biomedical education will be different. The physiotherapy program will be the same for both groups. Physiotherapy program will be applied after education in both groups. In the physiotherapy program, all participants will be given knee exercises and will be asked to take a walk twice a week as homework and suggestions will be made to reduce their sedentary behavior. The exercises given to both groups will be the same.
Telerehabilitation sessions for both groups:
- 3 sessions in total,
- 1 day a week for 3 weeks,
- Each session is approximately 15-20 minutes,
- Each session will include education, recommendations (especially about increasing physical activity and reducing sedentary behaviour), answering questions if any, and discussion.
The homework and suggestions to be given to the participants in the intervention group will be integrated with the pain science education, while the homework and suggestions to be given to the participants in the control group will be integrated with the biomedical education. For example, it will be explained to a participant in the intervention group that walking will regulate increased sensitivity in the central nervous system and ensure plasticity (using stories, examples in a way that the participant can understand). It will be explained to the participant in the control group that walking will strengthen their muscles and will be beneficial for general health and joint health.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Pain science education driven physiotherapy program, Biomedical education driven physiotherapy program
- Keywords
- Osteoarthritis, pain, knee, education
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain science education driven physiotherapy programOther
Pain science training will be carried out as described by Moseley and Butler. Topics covered within the scope of pain science education are planned to include: neurophysiology of pain, synapses, peripheral sensitization, central sensitization, plasticity of the nervous system. The aim of the training will be to teach participants that pain is a multifactorial experience rather than just tissue injury. Participants in this group will be told about the importance of physical activity integrated with pain science education (i.e., explaining that physical activity is the key to bioplasticity and causing changes in our system) and why sedentary behaviors should be reduced (reducing sedentary behaviors reduces the overprotectiveness of the pain system).
Biomedical education driven physiotherapy programOther
Participants in this group will be planned to increase their knowledge of knee anatomy, knowledge of knee OA and knee OA risk factors, and the importance of increasing physical activity and reducing sedentary behavior in reducing osteoarthritic pain and improving overall health. The importance of physical activity by integrating it with biomedical education (as physical activity can help strengthen muscles, protect joint function, and improve sleep and general health) and the necessity of reducing sedentary behaviors will be discussed within the framework of biomedical education.The main difference of standard education from pain science education will be that it does not contain information about pain mechanisms mentioned in pain science education.
| Study group | Role | What they receive |
|---|---|---|
| Pain science education group | Experimental | the program integrated with pain science education (exercise, walking program and recommendations for reducing sedentary behaviors) Receives: Other: Pain science education driven physiotherapy program |
| Biomedical education group | Experimental | the program integrated with biomedical education (exercise, walking program and recommendations for reducing sedentary behaviors) Receives: Other: Biomedical education driven physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)
Changes in pain frequency
Assessed using a closed question about knee pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in WOMAC (Western Ontario and McMaster Universities) index
womac will be used to assess pain, stiffness and physical function
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)
Changes in the level of pain catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Secondary outcomes (7)
Changes in fear of movement
assessed using the Tampa Scale of Kinesiophobia, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in health-related quality of life
assessed using the self-reported Short Form-12 questionnaire
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in physical activity level
assessed using the International Physical Activity Questionnaire (IPAQ) -Short Form.
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in sleep quality level
assessed using the Pittsburgh Sleep Quality Index (the higher score indicates worse sleep quality).
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in sedentary time and sedentary behavior
The questions to be used in the evaluation of sedentary behaviors and sedentary time were adapted using the scale developed by Salmon (Salmon et al, 2003).
The sedentary behaviors of the participants will be questioned for their activities in eight different categories. These activities include: watching television, using a computer, reading a book, surfing the Internet on the phone, engaging in arts \& games \& hobbies (e.g. playing chess, knitting, sewing, drawing), chatting or socializing, just doing nothing to rest, to travel by vehicles such as buses, cars.
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Evaluation of Satisfaction Level from Pain Science Education
Satisfaction will be measured through visual analogue scale 0-100mm (0= not satisfied at all; 100 = very satisfied).
Measured: T1 (within 1 week after the end of the face-to-face sessions)
Adherence to rehabilitation program
Adherence to the walking program will be calculated by evaluating the duration and frequency of their walks each week.
Adherence to the knee exercises will be calculated by evaluating the number of the days they exercise in each week.
Adherence to recommendations about sedentary behavior will be calculated by evaluating the total time they sit and the frequency and duration of the breaks they take while sitting.
Measured: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start2 Jan 2023
- Primary completion6 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Ata Tay, Marmara University
- Investigators
- Hilal Ata Tay, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649995
- Sponsor's protocol ID
- 092022160
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05649995
- Acronym / sponsor ID
- 092022160
- Conditions
- Osteo Arthritis Knee
- Keywords
- Osteoarthritis, pain, knee, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Dec 2022 (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 determine the effectiveness of the program integrated with pain science education for people with painful knee osteoarthritis (OA). Another purpose of the study is to evaluate whether the program integrated with pain science education is more effective than the program integrated with biomedical education.
Detailed description
Contemporary pain science education provides a scientific basis for the increased sensitivity produced in chronic pain due to adaptations in the central nervous system. In the literature, pain science education has been shown to reduce unhelpful pain beliefs and improve pain, function, and disability in several chronic musculoskeletal pain states, but data specific to knee OA are lacking.
Patients with knee osteoarthritis who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into two groups. These groups are: a) intervention group, where the program integrated with pain science education and b)control group, where the program integrated with biomedical education.
Three weeks of face-to-face sessions in both groups will be followed by three weeks of telerehabilitation sessions. Telerehabilitation sessions will be applied as phone calls or video conference sessions, according to the participant's request. All sessions will be conducted one-on-one.
Face-to-face sessions for both groups:
- 3 sessions in total,
- 1 day a week for 3 weeks,
- Each session will last approximately 60 minutes for the control group and the intervention group.
- Each face-to-face session will include education and physiotherapy program. Biomedical education for the control group and pain science education for the intervention group will be applied. Visuals and presentations will be used in the education of both groups. The presentations and visuals that will be used in pain science education and biomedical education will be different. The physiotherapy program will be the same for both groups. Physiotherapy program will be applied after education in both groups. In the physiotherapy program, all participants will be given knee exercises and will be asked to take a walk twice a week as homework and suggestions will be made to reduce their sedentary behavior. The exercises given to both groups will be the same.
Telerehabilitation sessions for both groups:
- 3 sessions in total,
- 1 day a week for 3 weeks,
- Each session is approximately 15-20 minutes,
- Each session will include education, recommendations (especially about increasing physical activity and reducing sedentary behaviour), answering questions if any, and discussion.
The homework and suggestions to be given to the participants in the intervention group will be integrated with the pain science education, while the homework and suggestions to be given to the participants in the control group will be integrated with the biomedical education. For example, it will be explained to a participant in the intervention group that walking will regulate increased sensitivity in the central nervous system and ensure plasticity (using stories, examples in a way that the participant can understand). It will be explained to the participant in the control group that walking will strengthen their muscles and will be beneficial for general health and joint health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain science education group | Experimental | Other: Pain science education driven physiotherapy programthe program integrated with pain science education (exercise, walking program and recommendations for reducing sedentary behaviors) |
| Biomedical education group | Experimental | Other: Biomedical education driven physiotherapy programthe program integrated with biomedical education (exercise, walking program and recommendations for reducing sedentary behaviors) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having been diagnosed with knee osteoarthritis according to the criteria of the American College of Rheumatology (ACR).
- Being between the ages of 45-65
- Having knee pain lasting at least 6 months
- Average knee pain intensity of ≥4 on 11- point numeric rating scale in the past week
- Having Turkish as mother tongue
Key exclusion criteria (7 listed)
- Having health problems (eg heart or lung disease) that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines.
- Neurological disorders affecting the lower extremity (eg multiple sclerosis or stroke)
- Using an assistive device
- Being diagnosed with OA in joint areas other than the knee joint
- Presence of inflammatory arthritis (including rheumatoid arthritis)
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 |
|---|---|---|
| Pain science education driven physiotherapy programPain science training will be carried out as described by Moseley and Butler. Topics covered within the scope of pain science education are planned to include: neurophysiology of pain, synapses, peripheral sensitization, central sensitization, plasticity of the nervous system. The aim of the training will be to teach participants that pain is a multifactorial experience rather than just tissue injury. Participants in this group will be told about the importance of physical activity integrated with pain science education (i.e., explaining that physical activity is the key to bioplasticity and causing changes in our system) and why sedentary behaviors should be reduced (reducing sedentary behaviors reduces the overprotectiveness of the pain system). | Other | Pain science education group |
| Biomedical education driven physiotherapy programParticipants in this group will be planned to increase their knowledge of knee anatomy, knowledge of knee OA and knee OA risk factors, and the importance of increasing physical activity and reducing sedentary behavior in reducing osteoarthritic pain and improving overall health. The importance of physical activity by integrating it with biomedical education (as physical activity can help strengthen muscles, protect joint function, and improve sleep and general health) and the necessity of reducing sedentary behaviors will be discussed within the framework of biomedical education.The main difference of standard education from pain science education will be that it does not contain information about pain mechanisms mentioned in pain science education. | Other | Biomedical education group |
Primary outcome
Changes in pain intensity
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Changes in pain frequency
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Assessed using a closed question about knee pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Changes in WOMAC (Western Ontario and McMaster Universities) index
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)
womac will be used to assess pain, stiffness and physical function
Changes in the level of pain catastrophizing
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
7 secondary outcomes
Changes in fear of movement
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in health-related quality of life
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in physical activity level
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in sleep quality level
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Changes in sedentary time and sedentary behavior
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)
Evaluation of Satisfaction Level from Pain Science Education
Time frame: T1 (within 1 week after the end of the face-to-face sessions)
Adherence to rehabilitation program
Time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)
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 7 Dec 2023.
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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.
Hilal Ata Tay principal investigator
Marmara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain science education driven physiotherapy program and Biomedical education driven physiotherapy program in people with Osteo Arthritis Knee, run by Marmara University at 2 sites 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 6 inclusion and 7 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 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Changes in pain intensity (time frame: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)). The study lists 4 primary outcomes in all. 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 7 Dec 2023.