Knee ArthroplastyNCT06009341
Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients
A study testing Rehabilitation in people with Knee Arthroplasty, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2023to 1 Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 50 and over
- Participants indicated for unilateral or bilateral total knee arthoplasty
- Individuals to be followed after surgery
Who cannot join
- Other surgeries
- Individuals with neurological and orthopedic diagnoses
- Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating
- Illiterate individuals
- Presence of malignancy
- Not signing the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients
In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.
- Conditions
- Knee Arthroplasty
- Being tested
- Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day. Receives: Other: Rehabilitation |
| Control Group | Active comparator | The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Short Form (KSSF)
The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.
Measured: Change from Baseline KSSF at 12 weeks
Visual Analog Scale (VAS)
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Measured: Change from Baseline VAS at 12 weeks
Tampa Scale for Kinesiophobia (TSK)
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Measured: Change from Baseline TSK at 12 weeks
EQ-5D-3L Quality of Life Scale
The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
Measured: Change from Baseline EQ-5D-3L at 12 weeks
Pain Catastrophising Scale (PCS)
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Measured: Change from Baseline PCS at 12 weeks
Activity Specific Balance Confidence Scale (ABC)
This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.
Measured: Change from Baseline ABC at 12 weeks
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
The Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.
Measured: Change from Baseline FFABQ at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start19 May 2023
- Primary completion30 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Fatih Özden, PhD, Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009341
- Sponsor's protocol ID
- Artroplasti gevşeme
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2023
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT06009341
- Acronym / sponsor ID
- Artroplasti gevşeme
- Conditions
- Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Aug 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, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationIn this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day. |
| Control Group | Active comparator | Other: RehabilitationThe control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 50 and over
- Participants indicated for unilateral or bilateral total knee arthoplasty
- Individuals to be followed after surgery
Key exclusion criteria (6 listed)
- Other surgeries
- Individuals with neurological and orthopedic diagnoses
- Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating
- Illiterate individuals
- Presence of malignancy
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 |
|---|---|---|
| RehabilitationThe control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications. | Other | Control Group, Intervention Group |
Primary outcome
Knee Society Short Form (KSSF)
Time frame: Change from Baseline KSSF at 12 weeks
The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.
Visual Analog Scale (VAS)
Time frame: Change from Baseline VAS at 12 weeks
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Tampa Scale for Kinesiophobia (TSK)
Time frame: Change from Baseline TSK at 12 weeks
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
EQ-5D-3L Quality of Life Scale
Time frame: Change from Baseline EQ-5D-3L at 12 weeks
The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
Pain Catastrophising Scale (PCS)
Time frame: Change from Baseline PCS at 12 weeks
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Activity Specific Balance Confidence Scale (ABC)
Time frame: Change from Baseline ABC at 12 weeks
This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
Time frame: Change from Baseline FFABQ at 12 weeks
The Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.
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 15 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Fatih Özden, PhD study director
Muğla Sıtkı Koçman 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 Rehabilitation in people with Knee Arthroplasty, run by Muğla Sıtkı Koçman 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 6 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 15 Dec 2025. 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?
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?
Knee Society Short Form (KSSF) (time frame: Change from Baseline KSSF at 12 weeks). The study lists 7 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 15 Dec 2025.