Knee Body Perception and Pain After Total Knee Arthroplasty

NCT07410884 | Completed

• 1 other identifier: 2020-19
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Arthroplasty, Total; Knee Osteoarthristis

Keywords

pain; disuturbed body perception; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• undergoing primary TKA for knee OA
• ability to understand and complete study questionnaires
• provision of informed consent.

You may not qualify if:

• prior knee surgery on the affected knee
• significant neurological or cognitive impairment
• diagnosis of rheumatoid arthritis
• having undergone unicompartmental knee arthroplasty (UKA).

Sponsors & Collaborators

• Prefectural University of Hiroshima: lead

Study Sites (1)

Prefectural University of Hiroshima

Mihara, 725-0053, Japan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: October 8, 2019
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)