The Effect of Rotator Cuff Repair on the Clinical and Psychological Meaningful Improvement in Patients with Rotator Cuff Tear and Insomnia.

Background: Rotator cuff repair is widely used to treat rotator cuff tear, but its impact on the psychological status in patients with rotator cuff tears and insomnia is still poorly understood. Methods: 240 patients were enrolled who underwent rotator cuff repair at the rst aliated hospital of soochow university from 2014-2018. During the 2-year follow-up period, the patients were assessed preoperatively and postoperatively at 3 months, 6 months, 12 months and 24 months by using Constant, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), American Shoulder and Elbow Surgeons’ Scale (ASES), Hospital Anxiety and Depression Scale, depression subsection (HADS-D), Hospital Anxiety and Depression Scale, anxiety subsection (HADS-A), and World Health Organization Quality-of-life Scale Abbreviated Version (WHOQOL-BREF). Results: Finally, a total of 240 patients were enrolled in this study and nished the 2 year follow-up.There were 107 men(43.8%) and 133 women(56.2%), and the mean age of the patients was 54.2±7.5 years. With the prolongation of postoperative time, pain, activity of daily life, joint mobility and muscle strength were gradually improved from 4.8 ± 2.2, 7.2 ± 3.4, 14.2 ± 5.5, 7.8 ± 3.5, and 34.0 ± 11.3, respectively, before surgery to 13.2 ± 3.2, 17.8 ± 2.8, 34.0 ± 6.4, 21.0 ± 4.0, and 85.9 ± 12.4, at 2 years after surgery, which was statistically signicant (P < 0.001).The scores of ASES and WHOQOL-BREF also increased signicantly from 40.5 ± 9.6, 58.3 ± 8.6 before operation to 87.7 ± 10.2, 69.3 ± 7.9 at two years after operation (P < 0.001). HADS-A decreased linearly from 4.8±2.4 before operation to 1.4 ± 1.2 at two years after operation (P < 0.01). The pain scores had a highly positive correlation with the Constant and the ASES scores. The PSQI and the ISI scores had a positive correlation with the HADS-A scores.


Background
Rotator cuff tear usually occurred in tennis, backstroke, free stroke, baseball, and other sports that required extreme repeated extension of shoulder, so athletes were the main group of patients in the past.
However, in recent years, epidemiological studies suggested that the incidence of rotator cuff tear was almost 17-41% in the mid and old aged, and was still rising [1].This was related to the aging and the popularity of national tness in China. With the development of health care, arthroscopic rotator cuff repair has become the "golden standard" for the treatment of rotator cuff tear, which had the advantage of slight injury and few complications [2]. It can make the function of shoulder and persistent pain better [3][4][5][6].
At present, most studies con rmed that the rotator cuff repair resulted in improved function and decreased pain [7]. However, the determinants of outcomes measured in these patients should not be limited to aspects of physical health. Persistent pain and insomnia resulting from rotator cuff tear was often accompanied by severe psychological distress, such as depression and anxiety, which was associated with poor postoperative outcomes. To some extent, psychological status predicted the outcome after surgery above and beyond prior physical health [8].
The quantity and quality of sleep can be in uenced by social, cultural, psychological, and behavioral aspects. For the patients with rotator cuff tear, insomnia is actually quite common and presents a worse perception of quality of life. Psychological distress will be an inevitable result as time passes [8]. It is very di cult to correct anxiety and depressive disorders built up subsequently [9,10]. Whereas, psychological distress will induce or exacerbate the original symptoms including insomnia and pain. Then they are trapped in this especially vicious circle. The impact of arthroscopic rotator cuff repair on the vicious circle is still unproven.
Therefore, the purpose of this study aimed to further understand the effect of rotator cuff repair on the clinical and psychological meaningful improvement, particularly in patients with rotator cuff tear and insomnia.

Participants
A retrospective study of arthroscopic rotator cuff repairs performed at the rst a liated hospital of Soochow University from 2014 to 2018 was conducted. All patients were diagnosed as having unilateral rotator cuff tear and diagnosis was based on clinical history, physical examination, and magnetic resonance imaging. All of the rotator cuff tears were insomnic, symptomatic and did not improve after three months of conservative therapy. Our institutional review board approved this study and all patients wrote informed consent. Cuff tears were repaired di cultly with or without severe concomitant lesion, which affected the postoperative outcome, in one patient. Three underwent the reoperation because of retears.
Baseline and follow-up evaluations were performed by a trained research assistant. Demographic data examined included age, sex, side, trauma history, smoking status, PSQI, ISI, tear size and combined lesions. There were 107 men (43.8%) and 133 women (56.2%), and the mean age of the patients was 54.2 ± 7.5 years. Among them, patients with right shoulder injuries and left shoulder injuries were 140 and 100. The average PSQI score before operation was 7.5 ± 3.2, and the average ISI score before operation was 11.8 ± 8.3. Other data were shown in Table 1.

Constant-Murley Score
The Constant-Murley Score includes 4 parts: pain degree, daily activity, shoulder joint mobility and muscle strength. Pain level is 15 points, daily activity is 20 points, shoulder joint mobility is 40 points, muscle strength is 25 points, total score is 100 points. As a complex scale, the scale needs to be completed by patients and doctors together. The subjective feelings of patients for their own diseases are evaluated by patients' lling in shoulder pain and its impact on daily activity. By measuring shoulder joint mobility and muscle strength lled in, doctors can objectively re ect patients' limited mobility and the damage caused by pathological changes to muscle strength, so as to comprehensively evaluate the patient's condition.

American Shoulder and Elbow Surgeons' Scale (ASES)
The ASES is an extensively used questionnaire for the functional evaluation of the shoulder [11]. It contains self-evaluation of patients and objective evaluation of doctors, including pain, activities of daily living, stability, mobility, muscle strength, and so on. The nal score needs to be converted into 100 points. The higher the score, the better the function of the shoulder. Scores 70 indicate poor function.

Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire with 19 items for assessing sleep quality over a 1-month time period [11]. It contains 7 aspects: subjective sleep quality, sleep latency, sleep duration, habitual sleep e ciency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The global score is range from 0 to 21; higher scores represent poorer subjective sleep quality. Scores ≤ 5 indicate good sleep quality, and scores > 5 indicate poor sleep quality.

Insomnia Severity Index (ISI)
The scale is a self-report measurement for assessing perceived insomnia severity [12]. It contains 7 items, The scale consists of 26 items, which are divided into four elds:physical, psychological, social relationships, environment [14]. The higher the score, the better the quality of life.
The paired t-test and chi-square test were used for single-factor analysis, and repeated-measures analysis of variance (ANOVA) was used to analyze measurements including Constant, PSQI, ISI, ASES, HADS-D,

HADS-A, and WHOQOL-BREF. The Pearson correlation was used to analyze the correlation between outcome measurements (Constant, ASES, HADS-D, HADS-A, and WHOQOL-BREF) and variables such as
Constant (pain), PSQI, and ISI. A p value of < 0.05 was considered statistically signi cant.

Results
With the prolongation of postoperative time, pain score, activity of daily life score, shoulder mobility score, muscle strength score and total score of Constant-Murley scale increased linearly, indicating that pain, activity of daily life, joint mobility and muscle strength were gradually improved, which was statistically signi cant (p < 0.001). The scores of ASES and WHOQOL-BREF also increased signi cantly from 40.5 ± 9.6, 58.3 ± 8.6 before operation to 87.7 ± 10.2, 69.3 ± 7.9 at two years after operation (p < 0.001). HADS-A decreased linearly from 4.8 ± 2.4 before operation to 1.4 ± 1.2 at two years after operation (p < 0.01). There was no signi cant change in HADS-D score during the 2-year follow-up period (p > 0.05) ( Table 2). As time passed, PSQI and ISI scores showed a linear downward trend, indicating that the sleep quality was gradually improved, and the variation at 3 months after surgery was greater than that in other months (Fig. 1 ). In Pearson correlation coe cient analysis, the pain scores had a highly positive correlation with the Constant and the ASES scores. The PSQI and the ISI scores had a positive correlation with the HADS-A scores. There was no correlation between pain scores and HADS-D, HADS-A or WHOQOL-BREF scores. The PSQI and ISI scores had no correlation with the Constant, ASES, HADS-D, and WHOQOL-BREF scores. (Table 3) Table 3 Correlation between variables and postoperative outcome measurements

Discussion
Current studies focused on the improvement of function and the relief of pain too much for postoperative patients rather than psychological status and HRQoL (Health Related Quality of Life). However, patientcentered subjective feeling and quality of life were more meaningful for the rotator cuff tears. Several studies also suggested that intense psychological distress may lead to dissatisfaction for treatment and disturb postoperative recovery in major orthopaedic procedures [15,16]. More recently, expectations and psychological predisposition have been discussed as the determinants of postoperative e cacy [15,16]. But psychological status of the rotator cuff tears are given neither the attention nor the prominence they deserve, especially for those suffering from insomnia.
Insomnia is a common complaint of patients with rotator cuff tears. In the study reported by Austin et al. [17], patients with symptomatic rotator cuff tears, the incidence of insomnia is 3 to 6-fold more common than in the general public. Inadequate and restless sleep, along with severe pain, is often a major contributor for them to face surgeries with determination. On the one hand, long-term sleep disturbance caused by pain will result in psychological distress, including anxiety and depression. On the other hand, mental problems will, in turn, exacerbate subjective symptoms and induce intractable insomnia that fails to respond to medications. In our study, there was a signi cant improvement in sleep until 6 months postoperatively, which was in accordance with other reports [18,17].
In terms of psychological status, HADS-D and HADS-A were used as evaluation parameters in our series. The number of people with anxiety and depression (HADS-A or HADS-D score ≥ 8 points) was 15 and 7, accounting for 6% and 3% respectively. It showed that the rotator cuff tears with insomnia do have psychological problems such as anxiety and depression, which was a quite common condition. Through the implementation of arthroscopic rotator cuff repair, it was found that the joint function, the sleep quality, the anxiety situation and the quality of life of patients has been signi cantly improved during the 2-year follow-up. But the impact on depression was not signi cant, which was consistent with the study of Cho C et al [19]. and Kennedy P et al. [20]. However, in Pearson correlation analysis, we found that there was a positive correlation between sleep disorder scores (PSQI and ISI) and anxiety scores, indicating that with the improvement of sleep quality, the anxiety status of patients will also be improved. To our surprise, data showed the weak correlation between relief of pain and psychological status. This nding suggested that anxiety was likely multifactorial and not simply a product of night pain. To some extent, sleep disorder at least have a stronger in uence on anxiety for the rotator cuff tears. However, sleep status had no signi cant effect on shoulder joint function and quality of life.
The rst limitation of the current study was the lack of a control group who had not undergone rotator cuff repair, which has the potential to produce prejudiced outcomes. Secondly, the in uence factors for psychological status are very complex, including chronicity of the tear, social condition, literacy level and family background. In fact, it is very hard to determine what changes the psychological status. Therefore, the selection of patients in this study could be biased. Thirdly, our ndings cannot explain the improvement of WHOQOL-BREF. This still needs further studies.
The results of our study indicate that rotator cuff repair can improve clinical outcome, as well as psychological status in patients with rotator cuff tear and insomnia. Rotator cuff repair also may mitigates sleep disturbance indirectly by alleviating pain.

Conclusions
The determinants of outcomes in patients with rotator cuff tear and insomnia are composed of the clinical outcome (pain, shoulder function, quality of life) and psychological status. Arthroscopic rotator cuff repair cannot only improve the clinical outcome, but also anxiety. Moreover, the improvement of insomnia is crucial to alleviating patients' anxiety after surgery. But insomnia cannot be used as an indicator to predict the clinical outcome.