Knee Arthroplasty, TotalNCT07410884
Knee Body Perception and Pain After Total Knee Arthroplasty
An observational study of Knee Arthroplasty, Total and Knee Osteoarthristis, run by Prefectural University of Hiroshima at 1 site in Japan.
Trial summary
This observational study aims to better understand how knee pain and knee-specific body perception are related over time after total knee arthroplasty (knee replacement) for knee osteoarthritis. Although most people improve after surgery, some continue to experience ongoing pain. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Arthroplasty, Total, Knee Osteoarthristis
- How many people
- 285 participants
- Where
- 1 siteJapan
- Study dates
- 8 Oct 2019to 24 Oct 2024
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults with knee osteoarthritis who are scheduled to undergo primary total knee arthroplasty at Fukuoka Orthopaedic Hospital. Participants are recruited consecutively from routine clinical practice and followed from the preoperative period through 12 months after surgery. Individuals are eligible if they can understand and complete study questionnaires and provide written informed consent. Key exclusions include prior surgery on the affected knee, significant neurological or cognitive impairment, rheumatoid arthritis, predominantly lateral compartment knee osteoarthritis, or planned unicompartmental knee arthroplasty.
Who may be able to join
- undergoing primary TKA for knee OA
- ability to understand and complete study questionnaires
- provision of informed consent.
Who cannot join
- prior knee surgery on the affected knee
- significant neurological or cognitive impairment
- diagnosis of rheumatoid arthritis
- having undergone unicompartmental knee arthroplasty (UKA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Associations Between Pain Intensity and Disturbed Body Perception After Total Knee Arthroplasty: A Random-Intercept Cross-Lagged Panel Model Analysis
This observational study aims to better understand how knee pain and knee-specific body perception are related over time after total knee arthroplasty (knee replacement) for knee osteoarthritis. Although most people improve after surgery, some continue to experience ongoing pain. Disturbed body perception such as feeling that the knee is less clear, less familiar, or difficult to "sense" or "control" as usual-has been linked to chronic musculoskeletal pain, but the timing of its relationship with postoperative pain after knee replacement is not well understood.
Adults undergoing primary total knee arthroplasty at Fukuoka Orthopaedic Hospital will be invited to participate. Participants will be asked to complete brief self-report questionnaires about (1) knee pain intensity during movement, (2) knee pain intensity at rest, and (3) knee-specific body perception (how the knee feels and is perceived). Pain intensity will be recorded using 100-mm visual analogue scales, and knee-specific body perception will be assessed using a validated questionnaire. Questionnaires will be completed before surgery (within one week prior) and at 1, 3, 6, and 12 months after surgery.
Read more
All surgical and rehabilitation care will be provided as part of usual clinical practice. Participation in this study involves completing questionnaires only and does not change clinical care. The study will examine whether within-person changes in knee body perception are associated with later changes in pain intensity across the first postoperative year, while also accounting for stable differences between individuals.
Information from this study may help identify potentially modifiable factors associated with persistent pain after knee replacement and may inform future research on rehabilitation strategies that target body perception and related sensorimotor processes. Study data will be handled confidentially in accordance with institutional policies, and analyses will be conducted on de-identified data whenever possible.
Read the detailed description
Knee osteoarthritis is a common cause of pain and disability, and total knee arthroplasty (TKA) is frequently performed to improve symptoms and function. Although many people experience substantial improvement after surgery, a subset report ongoing pain during recovery. Disturbed body perception (e.g., reduced clarity, altered awareness, or a sense that the knee feels unfamiliar) has been associated with persistent musculoskeletal pain, but the temporal ordering of postoperative pain and knee-specific body perception after TKA remains unclear.
This observational cohort study follows adults undergoing primary TKA and examines longitudinal associations between pain intensity (during movement and at rest) and knee-specific body perception across the first postoperative year. Participants complete brief self-report questionnaires at preoperative baseline and at multiple postoperative follow-up time points through 12 months. Clinical care (surgery, analgesia, and rehabilitation) is provided as usual and is not altered by study participation; the study procedures involve completion of questionnaires only.
The primary objective is to evaluate whether within-person changes in knee-specific body perception are prospectively associated with later within-person changes in pain intensity over time, while accounting for stable between-person differences. Longitudinal analyses will use random-intercept cross-lagged panel modeling to separate trait-like, between-person stability from state-like, within-person fluctuations and to estimate autoregressive and cross-lagged associations across adjacent waves. Missing questionnaire data will be handled using full-information maximum likelihood under a missing-at-random assumption, and sensitivity analyses will be conducted using the complete-case sample to evaluate robustness. Descriptive summaries and correlations will be used to characterize the observed trajectories and concurrent associations across time points.
The study is conducted in accordance with institutional ethical approval and written informed consent. Data are managed confidentially in line with institutional policies, and analyses are performed on de-identified data whenever possible. Findings are intended to inform future research on potentially modifiable factors related to persistent pain after TKA and to support development of rehabilitation strategies that may incorporate body perception-related approaches.
- Conditions
- Knee Arthroplasty, Total, Knee Osteoarthristis
- Keywords
- pain, disuturbed body perception, Total Knee Arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis | This cohort includes adults scheduled for primary total knee arthroplasty (TKA) for knee osteoarthritis at Fukuoka Orthopaedic Hospital. Participants are followed from the preoperative period through 12 months after surgery. The study is observational and does not assign any experimental intervention. Surgical care, postoperative analgesia, and rehabilitation are provided as part of usual clinical practice based on standard hospital protocols. The exposures of interest are within-person changes in knee-specific body perception and pain intensity over time. Participants complete self-report questionnaires assessing knee pain intensity during movement and at rest (100-mm visual analogue scales) and knee-specific body perception (Fremantle Knee Awareness Questionnaire) before surgery and at 1, 3, 6, and 12 months after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain Intensity at Rest (100-mm Visual Analogue Scale)
Resting pain intensity is assessed using a 100-mm visual analogue scale (VAS) anchored by "no pain" (0) and "worst possible pain" (100). Participants respond to: "Over the past week, how intense is your knee pain at rest?" and rate their average resting pain over the past week.
Measured: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty
Knee-Specific Body Perception Disturbance (Fremantle Knee Awareness Questionnaire; FreKAQ)
Knee-specific body perception disturbance is assessed using the Fremantle Knee Awareness Questionnaire (FreKAQ). Items are rated on a 5-point Likert scale (0=never to 4=always) and summed to a total score (range 0-36), with higher scores indicating greater disturbance in knee-specific body perception.
Measured: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty
Knee Pain Intensity During Movement (100-mm Visual Analogue Scale)
Pain intensity during movement is assessed using a 100-mm visual analogue scale (VAS) anchored by "no pain" (0) and "worst possible pain" (100). Participants respond to: "Over the past week, how intense is your knee pain during movement?" and rate their average pain during usual daily activities (e.g., level walking, sit-to-stand, stair negotiation).
Measured: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start8 Oct 2019
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prefectural University of Hiroshima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomohiko Nishigami, Prefectural University of Hiroshima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410884
- Sponsor's protocol ID
- 2020-19
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) are not planned to be shared publicly because the informed consent and institutional policies for this observational study did not include broad data-sharing provisions, and there is a risk of re-identification in a single-center dataset with detailed longitudinal measures. However, de-identified data may be considered for sharing on reasonable request for legitimate academic research, subject to review by the study investigators and approval under applicable ethics and data-use requirements.
Publications
Tomooka Y, Tanaka S, Mibu A, Manfuku M, Yamashita H, Ishida S, Yamada K, Tokunaga M, Wand BM, Stanton TR, Nishigami T. Temporal associations between pain intensity and disturbed body perception after total knee arthroplasty: a random-intercept cross-lagged panel model analysis. Pain. 2026 Sep 10. doi: 10.1097/j.pain.0000000000004107. Online ahead of print.
PubMed 42751721
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Associations Between Pain Intensity and Disturbed Body Perception After Total Knee Arthroplasty: A Random-Intercept Cross-Lagged Panel Model Analysis
- ClinicalTrials.gov ID
- NCT07410884
- Acronym / sponsor ID
- 2020-19
- Conditions
- Knee Arthroplasty, Total, Knee Osteoarthristis
- Keywords
- pain, disuturbed body perception, Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Prefectural University of HiroshimaUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 13 Feb 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.
This observational study aims to better understand how knee pain and knee-specific body perception are related over time after total knee arthroplasty (knee replacement) for knee osteoarthritis. Although most people improve after surgery, some continue to experience ongoing pain. Disturbed body perception such as feeling that the knee is less clear, less familiar, or difficult to "sense" or "control" as usual-has been linked to chronic musculoskeletal pain, but the timing of its relationship with postoperative pain after knee replacement is not well understood.
Adults undergoing primary total knee arthroplasty at Fukuoka Orthopaedic Hospital will be invited to participate. Participants will be asked to complete brief self-report questionnaires about (1) knee pain intensity during movement, (2) knee pain intensity at rest, and (3) knee-specific body perception (how the knee feels and is perceived). Pain intensity will be recorded using 100-mm visual analogue scales, and knee-specific body perception will be assessed using a validated questionnaire. Questionnaires will be completed before surgery (within one week prior) and at 1, 3, 6, and 12 months after surgery.
All surgical and rehabilitation care will be provided as part of usual clinical practice. Participation in this study involves completing questionnaires only and does not change clinical care. The study will examine whether within-person changes in knee body perception are associated with later changes in pain intensity across the first postoperative year, while also accounting for stable differences between individuals.
Information from this study may help identify potentially modifiable factors associated with persistent pain after knee replacement and may inform future research on rehabilitation strategies that target body perception and related sensorimotor processes. Study data will be handled confidentially in accordance with institutional policies, and analyses will be conducted on de-identified data whenever possible.
Detailed description
Knee osteoarthritis is a common cause of pain and disability, and total knee arthroplasty (TKA) is frequently performed to improve symptoms and function. Although many people experience substantial improvement after surgery, a subset report ongoing pain during recovery. Disturbed body perception (e.g., reduced clarity, altered awareness, or a sense that the knee feels unfamiliar) has been associated with persistent musculoskeletal pain, but the temporal ordering of postoperative pain and knee-specific body perception after TKA remains unclear.
This observational cohort study follows adults undergoing primary TKA and examines longitudinal associations between pain intensity (during movement and at rest) and knee-specific body perception across the first postoperative year. Participants complete brief self-report questionnaires at preoperative baseline and at multiple postoperative follow-up time points through 12 months. Clinical care (surgery, analgesia, and rehabilitation) is provided as usual and is not altered by study participation; the study procedures involve completion of questionnaires only.
The primary objective is to evaluate whether within-person changes in knee-specific body perception are prospectively associated with later within-person changes in pain intensity over time, while accounting for stable between-person differences. Longitudinal analyses will use random-intercept cross-lagged panel modeling to separate trait-like, between-person stability from state-like, within-person fluctuations and to estimate autoregressive and cross-lagged associations across adjacent waves. Missing questionnaire data will be handled using full-information maximum likelihood under a missing-at-random assumption, and sensitivity analyses will be conducted using the complete-case sample to evaluate robustness. Descriptive summaries and correlations will be used to characterize the observed trajectories and concurrent associations across time points.
The study is conducted in accordance with institutional ethical approval and written informed consent. Data are managed confidentially in line with institutional policies, and analyses are performed on de-identified data whenever possible. Findings are intended to inform future research on potentially modifiable factors related to persistent pain after TKA and to support development of rehabilitation strategies that may incorporate body perception-related approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis | – | –This cohort includes adults scheduled for primary total knee arthroplasty (TKA) for knee osteoarthritis at Fukuoka Orthopaedic Hospital. Participants are followed from the preoperative period through 12 months after surgery. The study is observational and does not assign any experimental intervention. Surgical care, postoperative analgesia, and rehabilitation are provided as part of usual clinical practice based on standard hospital protocols. The exposures of interest are within-person changes in knee-specific body perception and pain intensity over time. Participants complete self-report questionnaires assessing knee pain intensity during movement and at rest (100-mm visual analogue scales) and knee-specific body perception (Fremantle Knee Awareness Questionnaire) before surgery and at 1, 3, 6, and 12 months after surgery. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults with knee osteoarthritis who are scheduled to undergo primary total knee arthroplasty at Fukuoka Orthopaedic Hospital. Participants are recruited consecutively from routine clinical practice and followed from the preoperative period through 12 months after surgery. Individuals are eligible if they can understand and complete study questionnaires and provide written informed consent. Key exclusions include prior surgery on the affected knee, significant neurological or cognitive impairment, rheumatoid arthritis, predominantly lateral compartment knee osteoarthritis, or planned unicompartmental knee arthroplasty.
Key inclusion criteria (3 listed)
- undergoing primary TKA for knee OA
- ability to understand and complete study questionnaires
- provision of informed consent.
Key exclusion criteria (4 listed)
- prior knee surgery on the affected knee
- significant neurological or cognitive impairment
- diagnosis of rheumatoid arthritis
- having undergone unicompartmental knee arthroplasty (UKA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee Pain Intensity at Rest (100-mm Visual Analogue Scale)
Time frame: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty
Resting pain intensity is assessed using a 100-mm visual analogue scale (VAS) anchored by "no pain" (0) and "worst possible pain" (100). Participants respond to: "Over the past week, how intense is your knee pain at rest?" and rate their average resting pain over the past week.
Knee-Specific Body Perception Disturbance (Fremantle Knee Awareness Questionnaire; FreKAQ)
Time frame: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty
Knee-specific body perception disturbance is assessed using the Fremantle Knee Awareness Questionnaire (FreKAQ). Items are rated on a 5-point Likert scale (0=never to 4=always) and summed to a total score (range 0-36), with higher scores indicating greater disturbance in knee-specific body perception.
Knee Pain Intensity During Movement (100-mm Visual Analogue Scale)
Time frame: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty
Pain intensity during movement is assessed using a 100-mm visual analogue scale (VAS) anchored by "no pain" (0) and "worst possible pain" (100). Participants respond to: "Over the past week, how intense is your knee pain during movement?" and rate their average pain during usual daily activities (e.g., level walking, sit-to-stand, stair negotiation).
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 18 Feb 2026.
- Derived from this study: PubMed 42751721Tomooka Y, Tanaka S, Mibu A, Manfuku M, Yamashita H, Ishida S, Yamada K, Tokunaga M, Wand BM, Stanton TR, Nishigami T. Temporal associations between pain intensity and disturbed body perception after total knee arthroplasty: a random-intercept cross-lagged panel model analysis. Pain. 2026 Sep 10. doi: 10.1097/j.pain.0000000000004107. Online ahead of print.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) are not planned to be shared publicly because the informed consent and institutional policies for this observational study did not include broad data-sharing provisions, and there is a risk of re-identification in a single-center dataset with detailed longitudinal measures. However, de-identified data may be considered for sharing on reasonable request for legitimate academic research, subject to review by the study investigators and approval under applicable ethics and data-use requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total and Knee Osteoarthristis, run by Prefectural University of Hiroshima at 1 site in Japan.
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 4 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 18 Feb 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 Japan. 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 Pain Intensity at Rest (100-mm Visual Analogue Scale) (time frame: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410884, which also lists 1 linked publication.
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 18 Feb 2026.