1. Introduction
Total knee arthroplasty (TKA) is an effective treatment option for patients with end-stage knee osteoarthritis, providing pain relief, functional improvement, and health-related quality of life. Due to increasing levels of obesity, population aging, and growth in sports-related injuries, the incidence of TKA is high [
1]. Between 2000 and 2014, the estimated annual numbers of primary TKA increased by 148% in the United States. Based on this data, Sloan et al. showed that the projected growth for TKA procedures will reach 935,000 annually by 2030 in the US [
2].
The primary outcomes of the procedure are to improve the patient’s mobility in the postoperative period, enhance their functionality, alleviate pain significantly, and enhance self-confidence due to improved functionality [
3].
However, TKA is a painful procedure. The number of patients reporting moderate to severe pain after TKA remained relatively constant, with 58% reporting moderate to severe pain on postoperative day 1 (POD1), which only decreased to 43% by postoperative day 3 (POD3) [
4]. Pain in the postoperative period affects rehabilitation and increases the risk of complications in the acute phases and of developing chronic pain after surgery. Furthermore, up to 20% of patients are dissatisfied with the results of their surgery due to persistent pain and disability [
5].
Additional psychological factors, such as pain catastrophizing, pain-related fear of movement, and depression, have been identified as contributors to prolonged pain and disability in individuals with different musculoskeletal conditions [
6]. Patients may delay arthroplasty surgery due to the fear of acute postoperative pain [
7]. Pain catastrophizing is a term used to describe the tendency to magnify the threat value of pain stimuli and to feel helpless in the context of pain. This can lead to an inability to inhibit pain-related thoughts during or after a painful encounter [
8]. Kinesiophobia, on the other hand, is an excessive and debilitating fear of physical movement and activity due to a feeling of vulnerability from a painful injury or re-injury [
9]. It is gaining more attention since it can lead to illness behavior and create a vicious cycle of pain and disability [
10]. High levels of kinesiophobia after TKA negatively affect short- [
11,
12,
13] and long-term [
6,
10,
13,
14,
15,
16,
17] functional outcomes. Investigating the presence of kinesiophobia early after surgery can help arrange personalized treatment for this vulnerable group of patients.
Despite the growing interest in the relationship between kinesiophobia and TKA, there are limited studies on the etiology and psychological pattern of kinesiophobia in the literature. To the best of our knowledge, there are only two studies that examine the risk factors for the onset of kinesiophobia following TKA. Cai et al. showed that female sex, older age, lower levels of education, negative coping styles, lower self-efficacy, and pain were predictors of kinesiophobia after surgery [
18]. Degirmenci et al. demonstrated that the choice of anesthesia techniques during total knee arthroplasty (TKA) significantly influences the development of postoperative kinesiophobia [
19]. This study found that patients who received regional anesthesia and deep sedation were able to recover and move more confidently during the early postoperative period, while those who received regional anesthesia and light sedation experienced anxiety and fear, which made them hesitant to move [
19]. Studies have highlighted the importance of kinesiophobia as a risk factor for higher pain intensity following TKA [
10,
11,
15,
16,
17]. However, due to the lack of standardized pain measurements and the predominant use of unidimensional pain analysis, the relationship between patient-reported outcomes (PROs) and kinesiophobia has not been thoroughly investigated in any single study to date. PROs are reports coming directly from a patient about how they feel or function about a health condition and its therapy without interpretation by healthcare professionals or anyone else. PROs can relate to symptoms, signs, functional status, perceptions, or other aspects such as convenience and tolerability. PROs are not only important when more objective measures of disease outcome are not available but also represent what is most important to patients about a condition and its treatment [
20]. Gewandter et al. suggested that the inclusion of multiple domains in the outcomes can be a significant advantage as it provides a more thorough evaluation of the experiences of the individuals under study, rather than relying on a single factor that may not be sufficient in describing their overall experience [
21].
This study aimed to investigate the factors associated with kinesiophobia following TKA and to examine the relationship between kinesiophobia and early functional outcomes in TKA patients.
2. Materials and Methods
2.1. Setting
This observational study was conducted at the Clinic for Orthopedic Surgery and Traumatology, University Clinical Center Serbia in Belgrade over a period of 6 months. This study followed the principles of the Helsinki Declaration and was approved by the local ethics committee (Number 2017-004244-37). The findings in this study are based on the methodology outlined by PAIN OUT (
www.pain-out.eu), which provides a user-friendly online system for hospitals to gather standardized patient feedback and clinical data using a questionnaire available in more than 20 languages. The registry offers tools to evaluate pain-related patient-reported outcomes (PROs) and management on the first day after surgery (POD1), as described in
clinicaltrials.gov NCT02083835 [
22,
23]. Our research team was involved in creating the database used in this study, and this resource is also widely utilized by many hospitals worldwide.
Patients who had undergone TKA and who were 18 years or older, could communicate, and provided written consent were invited to participate in this study. The exclusion criteria included venous thromboembolism, neurological and musculoskeletal diseases that could affect recovery, and mental disorders. Written consent explained that the study aimed to improve pain treatment for patients after TKA in the future, and confirmed that no changes were being made to the standard medical care at the moment.
2.2. Surgical Technique, Anesthesia, Pain Management, and Postoperative Rehabilitation Program
The surgical procedure for TKA involved the insertion of tricompartmental prostheses using a standard medial parapatellar approach, with the use of cruciate-substituting designs. A femoral tourniquet at 300 mmHg was employed to achieve a bloodless surgical field. A compression bandage was applied from the toes to the mid-thigh at the end of the surgery. Spinal anesthesia with 10–15 mg levobupivacaine 0.5% or general anesthesia with propofol and fentanyl was administered during the procedure. Local infiltration anesthesia was not used in our study group. The regular protocol for pain management involved the scheduled assessment of pain and administration of non-opioid drugs (such as Paracetamol, Ketorolac, and Metamizol) and weak opioids (Tramadol) based on the severity of the pain reported by patients, and following the WHO’s approach to the use of analgesics based on pain severity. The pain was assessed at least once per shift. This treatment approach was implemented from POD1 to POD5.
All patients followed a standardized postoperative rehabilitation program beginning on POD1. Assisted ambulation and regular exercise to restore strength and mobility in the operated knee were performed 2 times a day for 20–30 min.
2.3. Data Collection
Patients were evaluated on POD1 and POD5.
- (1)
Baseline characteristics
On POD1, patients were assessed regarding demographic and clinical data comprising gender, year of birth (age), weight and height, intensity, and location of chronic pain before surgery. Furthermore, the type of anesthesia and duration of surgery were recorded.
- (2)
EuroQol-5D
Health-related quality of life during the last week before TKA was rated with the use of the EuroQol-5D (EQ5D) index score on POD1. After the surgery, we evaluated the patients’ overall well-being on POD5 using the same tool to determine the impact of TKA on their quality of life. An EQ5D index score of 0 indicates the worst possible health state and a value of 1 indicates full health [
24].
- (3)
Multi-dimensional assessment of pain on POD1 and POD5
The validated International Pain Outcomes Questionnaire (IPO-Q) was used to evaluate pain-related PROs [
23]. This questionnaire evaluates the following domains: intensity of pain and relief from treatments; interference of pain with physical activities in and out of bed; negative affect due to pain (anxiety and helplessness); adverse effects (AEs) (nausea, fatigue, dizziness, and itching); and perception of care (wish for more pain treatment, satisfaction with pain treatment, participation in decisions about pain treatment, and receipt of information about treatment). Pain intensity and pain-related physical and affective interference were quantified by patients using an 11-point numerical rating scale (0 = null, 10 = worst possible). The patient’s perception of care was assessed with yes or no on percentage scales. The data were collected by surveyors who underwent training before they approached patients. To reduce interviewer bias, patients completed the questionnaire independently with no assistance from family or staff. However, if a patient requested help, the surveyor could assist.
- (4)
Kinesiophobia on POD5
On POD5, kinesiophobia was measured with the Tampa Scale for Kinesiophobia (TSK). The TSK is a 17-item questionnaire designed to assess a patient’s fear of movement or (re)injury [
25]. Each point has a 4-point Likert scale, scoring alternatives from “strongly disagree” to “strongly agree”. The total score on the TSK ranges from 17 to 68 [
26]. We used a pre-validated cut-off score of 37 on the TSK to categorize knee replacement patients into two groups: those with no or low degrees of kinesiophobia (TSK‹37) and those with a high degree of kinesiophobia (TSK ≥ 37) [
25,
27].
- (5)
Functional outcome measures on POD5
On POD5, a functional assessment was conducted, which included three tests: knee range of motion (ROM), Barthel Index, and the 6 min walking test (6-MWT). The Barthel Index is an ordinal scale used to assess a person’s ability to perform ADL. It involves scoring 10 variables related to mobility and ADL, with a higher score indicating greater independence [
28]. The 6-MWT measures functional walking capacity. During the test, the patients were asked to walk for 6 min, and the distance covered in meters was recorded [
29]. Knee ROM was assessed using a universal goniometer, and the average peak knee flexion and extension were recorded from three trials. Health-related quality of life after TKA was rated using the EQ-5D index score.
2.4. Study Outcomes
The primary focus of this study was to identify predictors of kinesiophobia, while the secondary objective was to examine the association between kinesiophobia and functional outcomes.
2.5. Data Analysis
2.5.1. Creating Multidimensional Composite Scores
Multidimensional composite scores were created based on ratings obtained from the IPO-Q. For POD1 and POD5, continuous PROs were extracted from the questionnaires and combined to form composite scores, as described by Hofer D et al. [
30]. Three subscores were generated to assess pain intensity, pain-related interference, and side effects. The Pain Composite Score (PCS) was calculated using the formula: worst pain ×(% time in severe pain × 100) + least pain × (1 − % time in severe pain/100). The Pain Interference Total Score (PITS) was calculated as the mean of pain-related interference with activities in bed, breathing deeply/coughing, sleep, and pain-related anxiety and helplessness. The Pain Side Effects (PSE) composite score was calculated from the scores for dizziness, drowsiness, nausea, and itching [
30]. The Total Pain Composite Score (PCStotal) was formulated by averaging the continuous items derived from the pain intensity, pain interference, and side effects domains of the IPO-Q [
31].
2.5.2. Statistics
Statistical analysis was conducted using the Statistical Package for the Social Sciences (SPSS Inc., Chicago, IL, USA) version 22.0. Data were visually analyzed with histograms, Q–Q plots, and Kolmogorov–Smirnov tests for normality of distribution. Categorical and dichotomous data were presented as absolute frequencies and percentage of patients. Continuous data were presented as the median, first quartile (Q1), and third quartile (Q3), and NRS scores as a median with the interquartile range. The chi-square test was applied to test relationships between categorical variables. A two-sided independent samples t-test was used to compare the mean values of normally distributed data between 2 groups. Ordinal data were compared by the 2-sided Mann–Whitney U test.
Univariable and multivariable logistic regression analyses were performed to assess the factors associated with kinesiophobia. Variables with a
p-value < 0.20 in the unavailable analysis were retained and included in the multivariable regression, for which the backward selection method was used. Setting a threshold of 0.20 in the univariate analysis acts as an initial filter to capture a broader set of variables. This is crucial because some variables might show weak individual associations but can become significant when adjusted for other variables in a multivariable model [
32,
33,
34]. In the backward method, the model started with all variables in the equation. Using criteria for removal, variables that did not contribute to the solution were removed one at a time. The variable with the smallest partial correlation was taken out first. The steps proceed until no remaining variables are qualified for removal [
35].
No collinearity problem was detected for any of the models. In all instances, a p-value < 0.05 was considered statistically significant.
4. Discussion
In this study, we observed a kinesiophobia incidence of 27%, which is close to the rates reported in earlier studies in TKA patients in Serbia (22%) [
16] and China (24%) [
18]. Our findings indicate that the presence of kinesiophobia might be impacted by the intensity of preoperative pain. This observation is consistent with Kroska’s et al.’s postulation that fear avoidance behavior is often associated with higher pain intensity [
36].
The most important finding of our study was the confirmed link between PCStotal on POD1 and POD5 and the development of kinesiophobia. To the best of our knowledge, our results are the first to highlight the relationship of both the intensity of postoperative pain and the physical and emotional interference caused by pain after TKA, as they are associated with the presence of kinesiophobia. Prior studies on TKA patients primarily relied on pain intensity and used single-dimensional measures to assess pain [
16,
18,
19]. Moreover, research on risk factors for kinesiophobia after TKA found a direct link between high pain intensity levels within the first 24 h after surgery and increased levels of kinesiophobia [
18]. Composite scores for pain, which combine pain intensity, pain-related interference, and side effects, offer a unique approach that provides a holistic view of the pain experience [
21,
30]. This approach provides a broader perspective compared to using a single measure [
21].
To evaluate the influence of kinesiophobia on early functional outcomes, we used the 6-MTW, knee ROM, and Barthel index. Our study’s findings support previous research regarding the 6-MWT and its relation to kinesiophobia. Doury-Panchout et al. demonstrated that patients without kinesiophobia walked a significantly greater distance during the 6-MWT compared to those with kinesiophobia [
15]. Additionally, Guney Deniz et al. found a positive correlation between higher TSK scores and improved 2-MWT scores [
12]. Similarly, Degirmenci et al. discovered that higher TSK scores were associated with better 2-MWT scores and Timed Up and Go (TUG) test results on POD 2 and POD 5 [
19]. Based on our findings, it appears that there might be an inverse correlation between active knee extension and kinesiophobia, while no correlation was observed with knee flexion. However, it is important to note that not all studies align with these results. Active knee flexion was found to be correlated with TSK in several studies [
12,
16,
19,
37]. In contrast, Doury-Panchout et al. did not observe any notable disparity in maximum passive flexion and maximum active extension on the day of discharge between high-TSK and low-TSK groups [
15]. Similarly, Filardo et al. found no connection between high-TSK and low-TSK groups concerning active or passive ROM [
38]. In addition, our study revealed the negative relationship between higher levels of kinesiophobia and functional independence as measured with the Barthel index on POD5.