An Estimation Formula for Resonance Frequency Using Sex and Height for Healthy Individuals and Patients with Incurable Cancers.

Resonance frequency breathing is a technique that involves breathing that maximizes heart rate variability. It is specific to individuals and is determined through a procedure taking approximately 30 min, using a procedure that is often best carried out at specialized medical institutions. This is a physical and time-consuming burden because of hospital visits and measurements, particularly for patients with cancer. Therefore it would be beneficial if a procedure can be found to determine resonance frequency from the patient's physical characteristics, without the need for special assessment procedures. This exploratory cross-sectional study examined the correlation between individual characteristics and resonance frequency in healthy volunteers. Multiple regression analysis was performed with the measured resonance frequency as the target variable and individual characteristic parameters as explanatory variables. The study aims to build an estimation formula for resonance frequency with some of these parameters and assess its validity. In addition, the validity of the formula's applicability to patients with incurable cancers is assessed. A total of 122 healthy volunteers and 32 patients with incurable cancers were recruited as participants. The median resonance frequency of 154 participants was six breaths per min. Sex and height were selected as explanatory variables associated with the measured resonance frequency in the volunteers. The estimation formula for resonance frequency using individual characteristics was 17.90-0.07 × height for men and 15.88-0.06 × height for women. Adjusted R-squared values were 0.55 for men and 0.47 for women. When the measured resonance frequency in patients with incurable cancers was six breaths per minute or less, the resonance frequency estimated by this formula was slightly larger than the measured ones. Information on individual characteristics, such as sex and height, which can be easily obtained, was useful to construct an estimation formula for resonance frequency.

Stress Response Pattern of Heart Rate Variability in Patients with Functional Somatic Syndromes.

Functional somatic syndromes (FSSs) represent a clinically important group of disorders that are often stress-related. Their autonomic pathophysiology, including reduced heart rate variability (HRV), has been reported. However, the response pattern to mental stress and recovery in FSSs remains unclear. Thus, we aimed to clarify the pattern of autonomic stress response and recovery to mental arithmetic stress in patients with FSS compared to that in healthy controls. This cross-sectional study included 79 patients with FSS who visited the Department of Psychosomatic Medicine at a university hospital in Japan and 39 healthy controls. Following a mood questionnaire and obtaining epidemiologic information, HRV was measured during three periods (5 min each): relaxation baseline resting, stress (mental arithmetic task), and post-stress recovery period. The HRV analysis included inter-beat interval, low frequency power, and high frequency power. Compared to healthy controls, patients with FSS exhibited significantly higher scores on the mood questionnaire, prolonged duration of illness, and decreased functionality in daily activities. While the healthy control group showed a pronounced stress response pattern with a significant decrease in vagal HRV and recovery, the FSS group showed a "flat" vagal stress response pattern, and the HRV in the FSS group was lower at relaxation baseline, remained low during the stress, and did not change post stress. Patients with severe FSS exhibit an altered stress response pattern. Our results could provide significant clues for the diagnosis and treatment of such patients, as well as useful insights into the relationship between stress and illness.

Clinical practice guidelines for the care of psychologically distressed bereaved families who have lost members to physical illness including cancer.

The Japanese Psycho-Oncology Society and the Japanese Association of Supportive Care in Cancer developed evidence-based clinical practice guidelines for the care of psychologically distressed bereaved families who have lost members to physical illness including cancer. The guideline development group formulated two clinical questions. A systematic literature review was conducted. The level of evidence and the strength of the recommendations were graded and recommendation statements validated using the modified Delphi method. The recommendations were as follows: non-pharmacological interventions were indicated for serious psychological distress (depression and grief); antidepressants were indicated for depression; however, psychotropic medications including antidepressants were not recommended for 'complicated' grief. These guidelines will facilitate the provision of appropriate care to distressed bereaved family members and highlight areas where further research is needed.

Prevalence of Myofascial Pain Syndrome and Efficacy of Trigger Point Injection in Patients with Incurable Cancer: A Multicenter, Prospective Observational Study (MyCar Study).

OBJECTIVE: Myofascial pain syndrome (MPS) is caused by overload or disuse of skeletal muscles. Patients with cancer are often forced to restrict their movement or posture for several reasons. The study was conducted to investigate the prevalence and risks of MPS in patients with incurable cancer. The efficacy of trigger point injection (TPI) was also explored. METHODS: This was a multicenter, prospective observational study. Patients with incurable cancer who started receiving specialist palliative care were enrolled. We investigated the MPS in this population and accompanying risk factors for restricting body movement. Pre- and post-TPI pain was also evaluated using a Numerical Rating Scale (NRS) in patients who received TPI. The primary outcome was the prevalence of MPS. RESULTS: A total of 101 patients were enrolled from five institutions in Japan. Most of the patients (n = 94, 93.1%) had distant metastases, and half of the patients (50, 49.5%) received anticancer treatment. Thirty-nine (38.6%) patients had MPS lesions at 83 sites. Multivariate analysis revealed that the significant risk factor for MPS was poor Performance Status (PS) (odds ratio 3.26; 95% confidence interval [CI] 1.18-9.02, P = .023). We performed TPI for 40 out of 83 MPS lesions. Mean NRS for MPS before TPI was 7.95, which improved to 4.30 after TPI (P < .001). CONCLUSIONS: MPS was common in patients with incurable cancer and the risk factor identified in this study was poor performance status. TPI could be a treatment option.

The Association Between Heart Rate Variability and Quality of Life in Patients with Functional Somatic Syndrome and Healthy Controls.

Functional somatic syndrome (FSS) includes a spectrum of somatic symptoms with insufficient medical explanation. Its underlying pathophysiology is considered to include dysfunctional stress-responsive systems or autonomic dysfunction. Among the autonomic dysfunction readouts, decreased heart rate variability (HRV) has been shown to be characteristic in patients with FSSs. However, its association with quality of life (QOL) has not been clearly examined. We examined the association between short-term resting HRV and QOL in patients with FSS (n = 47) and healthy controls (n = 28). The time domain parameters of HRV were mean heart rate per minute (HR), coefficient of variation of R-R intervals (CvRR) and root mean square of successive differences (RMSSD). The frequency domain parameters of HRV were low-frequency (LF) power and high-frequency (HF) power by power spectrum analysis. The Japanese version of the WHO's QOL scale (WHOQOL-BREF) (WHO/QOL26) was used for the QOL assessment. There was a significant positive association between the RMSSD and HF power of HRV and all the QOL domains in patients with FSSs who had lower QOL scores on average than controls, while there was no association between HRV and any of the QOL domains in the control group. HF power was more dominantly associated with QOL than the other variables in patients with FSS based on the analysis with a multiple linear regression model. The present study elucidated that the HF power of HRV was dominantly associated with QOL in patients with FSSs who had lower QOL than controls. Vagal index of HRV could be a valuable indicator of the pathological condition and a significant predictor of health-related QOL in patients with FSSs.

JPOS/JASCC clinical guidelines for delirium in adult cancer patients: a summary of recommendation statements.

BACKGROUND: The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer recently launched the clinical practice guidelines for delirium in adult cancer patients. The aim of the guidelines was to provide evidence-based recommendations for the clinical assessment and management of delirium in cancer patients. This article reports the process of developing the guideline and summarizes the recommendations made. METHODS: The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multidisciplinary members, formulated nine clinical questions. A systematic literature search was conducted to identify relevant articles published prior to through 31 May 2016. Each article was reviewed by two independent reviewers. The level of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development and Evaluation system. The modified Delphi method was used to validate the recommendation statements. RESULTS: This article provides a summary of the recommendations with rationales for each, as well as a short summary. CONCLUSIONS: These guidelines will support the clinical assessment and management of delirium in cancer patients. However, additional clinical studies are warranted to further improve the management of delirium.

Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial-JORTC-PAL08 (DIRECT) study.

PURPOSE: Duloxetine has some effect against cancer neuropathic pain (CNP); however, predictors of duloxetine response are unclear. This study sought to identify predictors of duloxetine response in patients with CNP. METHODS: Patients (N = 70) with CNP unresponsive to or intolerant of opioid-pregabalin combination therapy, with a brief pain inventory-short form (BPI-SF) Item 5 score (average pain) ≥ 4, and with a total hospital anxiety and depression scale score < 20, were randomized to a duloxetine or a placebo group. Multiple linear regression analysis was conducted to identify predictors of duloxetine response as a secondary analysis with the change in the average pain score on day 10 from day 0 as the dependent variable, and the following five covariates; baseline (day 0) average pain score, baseline opioid dose, continuation/discontinuation of pregabalin, and items 20 and 21 score of the short-form McGill pain questionnaire 2 (SF-MPQ-2) as independent variables. RESULTS: Of the four domains (continuous pain, intermittent pain, neuropathic pain, and affective descriptors) score of SF-MPQ-2 on day 0, significant differences were observed in the neuropathic pain domain (p = 0.040) in change on the average pain between day 10 and day 0 in the duloxetine group. Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). CONCLUSION: Patients with a high score for SF-MPQ-2 Item 21 might benefit more from duloxetine.

[Locally Advanced Breast Cancer Treated with Mohs' Paste and Neoadjuvant Chemotherapy-A Case Report].

Cutaneous infiltration by breast cancer significantly reduces patient quality of life(QOL)due to bleeding, exudate, and pain. We report a case of combined treatment using Mohs' paste and neoadjuvant chemotherapy for locally advanced breast cancer. Mohs' paste decreased bleeding and exudate from the tumor and neoadjuvant chemotherapy combined with bevacizumab down-staged a large tumor to a volume that permitted mastectomy. Good local control using Mohs' paste and neoadjuvant chemotherapy can improve patient QOL and reduce the physical burden.

Hypnotic Intervention for Unexplained Dizziness in Patients with Advanced Cancer: A Preliminary Retrospective Observation Study.

CONTEXT: Patients with advanced cancer rarely complain of unexplained dizziness after excluding identifiable causes. Some patients become anxious because they attribute the dizziness to the progression of their cancer. We hypothesize that unexplained dizziness is associated with neck muscle hypertonicity, a noncancer-related secondary effect. However, most cases are associated with neck muscle hypertonicity, a noncancer-related secondary effect. AIMS: We evaluated the usefulness of hypnotic intervention that made patients aware of the relation between dizziness and neck muscle hypertonicity through the experience of muscle relaxation and recognition of muscle tension. SETTINGS AND DESIGN: Advanced cancer patients requiring palliative care with unexplained dizziness who received the intervention to induce neck muscle relaxation were retrospectively compared with patients who did not. SUBJECTS AND METHODS: The severity of dizziness that was evaluated using a numeric rating scale and the intervention efficacy rate were compared between the hypnotic and nonhypnotic groups as the primary endpoints, 7 days after the start of the intervention. Secondary endpoints included the effect size based on dizziness handicap inventory (DHI) scores before and after the intervention, and changes in patients' awareness of the cause of dizziness. RESULTS: The hypnotic intervention had a significantly greater efficacy rate (0.67, 95% confidence interval: 0.46-0.88) than the nonhypnotic intervention (0.26, 95% confidence interval: 0.08-0.44). DHI scores, especially on the emotional subscale, showed significant improvement after the intervention, and 71% of the patients were aware that neck muscle hypertonicity was the cause of dizziness. CONCLUSIONS: The rapid improvement in dizziness in the hypnotic group was considered to result from a change in patients' awareness of self-manageable neck muscle hypertonicity as the cause of dizziness.

Myofacial Trigger Points in Advanced Cancer Patients.

Myofascial pain syndrome is started to be recognized as one of important factors of pain in cancer patients. However, no reports on features of myofascial trigger points were found in terminally-ill cancer populations. This time, we encountered 5 patients with myofascial pain syndrome and terminal cancer in whom delirium developed due to increased doses of opioid without a diagnosis of myofascial pain syndrome on initial presentation. The delirium subsided with dose reductions of opioid and treatment of myofascial pain syndrome. The common reason for a delayed diagnosis among the patients included an incomplete palpation of the painful sites, which led to unsuccessful myofascial trigger points identification. The features of myofascial trigger points included single onset in the cancer pain management site with opioid and the contralateral abdominal side muscles of the non-common sites. Withdrawal reflexes associated with cancer pain in the supine position, which are increasingly seen in the terminal cancer patients, were considered to have contributed to this siuation. We consider that careful palpation of the painful site is important, in order to obtain greater knowledge and understanding of the features of myofascial trigger points.

Dyspnea, relative youth and low daily doses of opioids predict increased opioid dosage in the last week of a terminal cancer patient's life.

OBJECTIVE: Most cancer patients become increasingly anxious toward the end of their life. The objective of this study was to identify predictors of increased opioid dosage in the last week of a terminal cancer patient's life. METHODS: We retrospectively reviewed charts of patients who died in our palliative care unit. We assigned the patients to increased group or decreased group according to changes in oral morphine equivalent dosage in their last 7 days. Logistic regression analysis was used to identify predictors of increased oral morphine equivalent dosage. RESULTS: We analyzed data of 158 patients (female: 43.7%, median age: 64 years). The median oral morphine equivalent dosages on Days 7 and 1 before death were 50 mg (interquartile range: 24-122) and 61 mg (28-129), respectively. Independent predictors of increased oral morphine equivalent dosage included dyspnea (odds ratio: 11.5, 95% confidence interval: 4.98-28.83, P < 0.01), age <65 years (odds ratio: 2.3, 95% confidence interval: 1.04-5.26, P = 0.04) and oral morphine equivalent dosage <50 mg on Day 7 before death (odds ratio: 3.7, 95% confidence interval: 1.68-8.89, P < 0.01). The median oral morphine equivalent dosages on Days 7 and 1 before death were 48 mg (interquartile range: 20-126) and 75 mg (36-170) in patients with dyspnea, and 50 mg (25-120) and 57 mg (25-124) in patients with pain, respectively. CONCLUSIONS: Dyspnea, relative youth and oral morphine equivalent dosage <50 mg on Day 7 before death were predictive of increased oral morphine equivalent dosage in the last 7 days. Our findings may help oncologists to more accurately inform patients about expected opioid requirements and thus relieve their end-of-life anxiety.

Relationship between dyspnoea and related factors in patients with cancer: a cross-sectional study.

OBJECTIVES: Dyspnoea is a common and distressing symptom in patients with cancer. We aimed to analyse the association between dyspnoea and related factors and to estimate their causal relationship. METHODS: A cross-sectional study was conducted. Patients with cancer with dyspnoea and a mean Numerical Rating Scale (NRS) of ≥3 over 24 hours were enrolled at 10 institutions in Japan from December 2019 to February 2021. The outcomes included dyspnoea, cough and pain NRS over 24 hours, Eastern Cooperative Oncology Group Performance Status, Hospital Anxiety and Depression Scale, Somatosensory Amplification Scale, opioids for dyspnoea and respiratory failure. Path analyses were conducted to estimate the direct and indirect paths with reference to dyspnoea and related factors. RESULTS: A total of 209 patients were enrolled and 208 patients were included in the analysis. Cough worsened dyspnoea (ß=0.136), dyspnoea increased emotional distress (ß=1.104), emotional distress increased somatosensory amplification (ß=0.249) and somatosensory amplification worsened cough (ß=0.053) according to path analysis. CONCLUSION: There may be a vicious circle among dyspnoea and related factors: cough worsened dyspnoea, dyspnoea increased emotional distress, emotional distress increased somatosensory amplification and somatosensory amplification worsened cough. When treating dyspnoea in patients with cancer, managing these factors aimed at interrupting this vicious circle may be useful. TRIAL REGISTRATION NUMBER: UMIN Clinical Trials Registry (UMIN000038820).

Short-term efficacy of home-based heart rate variability biofeedback on sleep disturbance in patients with incurable cancer: a randomised open-label study.

OBJECTIVES: Early palliative care reportedly contributes to the quality of life by improving coping skills in patients with cancer. The aims of the study are to (1) Build a self-coping system that makes it possible to perform a session of home-based heart rate variability biofeedback (HRV-BF) with resonant breathing in patients with sleep disturbance and to acquire its techniques early on, and (2) Examine its short-term efficacy and feasibility. METHODS: A randomised, open-label, comparative study was conducted in the presence or absence of home-based HRV-BF with resonant breathing using a portable HRV-BF device prior to bedtime. The participants were 50 patients with incurable cancer with sleep disturbance who underwent a hospital practice of HRV-BF with resonant breathing. The primary end point was the rate of change in sleep efficiency for 10-14 days. The Japanese version of the Pittsburgh Sleep Quality Index (subjective indicator) and actigraphy sleep parameters (objective indicators) were used for sleep assessments. RESULTS: The completion rate and implementation rate in the home-based HRV-BF group (n=25) were 96.0% and 91.4%, respectively. This group showed a significant improvement in sleep efficiency, sleep duration and the low-frequency component of HRV. Sleep latency worsened in this group, but a significant difference was not observed. CONCLUSIONS: A home practice of HRV-BF with resonant breathing made it possible to acquire its techniques early on and improve sleep and autonomic function; therefore, our study showed high short-term efficacy and feasibility required for a self-coping system.

Patients with postprandial distress syndrome experience problems with their interoceptive perceptual function to the gastric region, but their heartbeat perception is normal: a case control study.

BACKGROUND: Visceral hypersensitivity in functional dyspepsia can be localized or widespread, and there is no simple method of assessment. Measuring interoceptive accuracy at different sites provides an assessment of perceptual hypersensitivity to specific ecological phenomena. The purpose of this study was to characterize visceral hypersensitivity by comparing gastric sensory and cardiac perceptual tests in patients with postprandial distress syndrome and in healthy volunteers. METHODS: Sixteen patients with postprandial distress syndrome (age = 47.5 ± 17.4, all female) and 16 healthy volunteers (age = 43.3 ± 16.1, all female) participated in the study after a six-hour fast. Each participant answered questionnaires about physical and mental quality of life, depression and anxiety, tendency of alexithymia, and somatosensory amplification. After completing the questionnaire, the participants took the heartbeat tracking task and the five-minute water load test. We performed statistical analysis using the Mann-Whitney U test and Spearman's rank correlation coefficient. RESULTS: Subjects with postprandial distress syndrome had a lower drinking capacity than healthy volunteers (postprandial distress syndrome = 360.9 ± 170.0 mL, healthy volunteers = 644.1 ± 297 mL, P = 0.009), but there was no significant difference in the heartbeat perception score (postprandial distress syndrome = 0.599 ± 0.175, healthy volunteers = 0.623 ± 0.181, P = 0.647). There was a negative correlation (r = - 0.509, P < 0.05) between drinking capacity and the heartbeat perception score in healthy volunteers, but no correlation in postprandial distress syndrome (r = - 0.156, P = 0.564). Heartbeat perception score did not correlate with psychological measures. CONCLUSIONS: Compared with healthy volunteers, only the five-minute water load test values were reduced in patients with postprandial distress syndrome, and no difference was observed in the heartbeat tracking task. Combining the 5-minute water load test and the heart rate tracking task revealed a lost cardiac-gastric perceptual relationship in patients with postprandial distress syndrome that was not observed in healthy volunteers, suggesting that there is hypersensitivity in gastric interoceptive perceptual function. Performing sensory examinations at two different sites may be useful in clarifying whether visceral hypersensitivity is localized. TRIAL REGISTRATION: UMIN000057586. Registered11 March 2023(retrospectively registered).

Effects of eating together online on autonomic nervous system functions: a randomized, open-label, controlled preliminary study among healthy volunteers.

BACKGROUND: Eating alone has been significantly associated with psychological distress. However, there is no research that evaluates the effects or relation of eating together online to autonomic nervous system functions. METHODS: This is a randomized, open-label, controlled, pilot study conducted among healthy volunteers. Participants were randomized into either an eating together online group or an eating-alone group. The effect of eating together on autonomic nervous functions was evaluated and compared with that of the control (eating alone). The primary endpoint was the change in the standard deviation of the normal-to-normal interval (SDNN) scores among heart rate variabilities (HRV) before and after eating. Physiological synchrony was investigated based on changes in the SDNN scores. RESULTS: A total of 31 women and 25 men (mean age, 36.6 [SD = 9.9] years) were included in the study. In the comparison between the aforementioned groups, two-way analysis of variance revealed interactions between time and group on SDNN scores. SDNN scores in the eating together online group increased in the first and second halves of eating time (F[1,216], P < 0.001 and F[1,216], P = 0.022). Moreover, high correlations were observed in the changes in each pair before and during the first half of eating time as well as before and during the second half of eating time (r = 0.642, P = 0.013 and r = 0.579, P = 0.030). These were statistically significantly higher than those in the eating-alone group (P = 0.005 and P = 0.040). CONCLUSIONS: The experience of eating together online increased HRV during eating. Variations in pairs were correlated and may have induced physiological synchrony. TRIAL REGISTRATION: The University Hospital Medical Information Network Clinical Trials Registry, UMIN000045161. Registered September 1, 2021. https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000051592 .

Effect of visual feedback during ultrasound-guided hydrodissection for myofascial pain syndrome: An exploratory, prospective, observational clinical trial on the expectations for treatment.

Expectations for treatment have a favorable effect on the subsequent course of pain and behavior in patients. It is not known whether receiving hydrodissection while patients view their ultrasound image with doctors (visual feedback) is associated with positive treatment expectations. This was an exploratory, prospective, observational clinical trial. We explored the possibility that visual feedback immediately after ultrasound-guided hydrodissection increases the expectations for treatment, which could be one of the related factors for pain reduction. Treatment expectations were set as mediators of pain using path analysis. The primary endpoint was the numerical rating scale to assess expectations for treatment immediately after hydrodissection, between with and without the visual feedback. During 2019 and 2020, 136 outpatients received ultrasound-guided hydrodissection for myofascial pain syndrome. Of these, 65 (47.8%) patients received visual feedback during ultrasound-guided hydrodissection. Compared with the non-visual feedback group, the visual feedback group had higher expectations for treatment immediately after hydrodissection, and their expectations were maintained at day 14 of treatment (p < 0.001). A numerical rating scale (NRS) to assess expectations for treatment was similar before hydrodissection and immediately after hydrodissection was 8.4 (standard deviations, 1.6) in the visual feedback and 5.9 (standard deviations, 2.6) in the visual feedback. The proportion of increased expectations immediately after hydrodissection was 90.8% (95% CI: 83.7-97.9) in visual feedback group and 38.0% (95% CI: 26.7-49.3) in non-visual feedback group (p < 0.001). In the visual feedback group, 67.7% of patients showed improvement in pain numerical rating scale score by 50% or more at day 14, whereas such improvement was observed in only 36.6% of the non-visual feedback group (p < 0.001). Based on path analysis, the visual feedback had the greatest influence on pain numerical rating scale reduction at 14 days, indirectly due to increased expectations for treatment as a mediator (ß = 0.434). However, the adjusted R 2 values, which is the overall fit of the model, was low at 0.298. Visual feedback during ultrasound-guided hydrodissection increases the expectations for treatment immediately after hydrodissection, which could be one of the related factors for pain reduction in patients with myofascial pain syndrome.

Relationships between alexisomia and the presence of latent trigger points in the upper trapezius of healthy volunteers.

BACKGROUND: Alexisomia is characterized by difficulties in the awareness and expression of somatic feelings. Trigger points are classified into two types, active and latent, according to the presence or absence of identifying spontaneous pain. OBJECTIVE: We aimed to examine the association between alexisomia and the presence of latent trigger points (LTrPs) in the upper trapezius of healthy volunteers. METHODS: This study was designed as a cross-sectional survey. A correlation analysis between the Shitsu-Taikan-Sho Scale (STSS) and LTrPs was performed on 154 healthy volunteers. The LTrP odds ratio for healthy volunteers with alexisomia was selected as the primary endpoint. RESULTS: LTrPs were seen in the upper trapezius of 82 healthy volunteers (53.2%). There was no significant difference between the LTrP and non-LTrP groups in STSS total score (p= 0.11). However, there was a significant difference between them in STSS difficulty of identifying bodily feelings (DIB) score (p= 0.03). In the alexisomic versus non-alexisomic groups, the LTrP odds ratio for STSS total score was 2.30 (95% confidence interval [CI] 1.03-5.10) and for STSS DIB score, 2.08 (95% CI 1.05-4.11). CONCLUSIONS: In STSS DIB in particular, alexisomia was associated with the presence of LTrP in the upper trapezius of healthy volunteers.

Effect of ischemic compression performed by family caregivers on myofascial pain syndrome and the care burden of the families of patients: a multicenter open-label randomized comparative study.

BACKGROUND: Ischemic compression is a manual therapy technique for myofascial pain. This study aimed to verify the effect of ischemic compression performed by family caregivers on myofascial pain syndrome (MPS) in patients and on the family's care burden. METHODS: This multicenter, open-label, randomized, comparative study included patients with myofascial pain and their family caregivers who were randomized into the following groups: ischemia compression (performed by a family caregiver), sham ischemia compression, or untreated control. The effectiveness and safety of ischemic compression and the burden on family caregivers were evaluated. The primary endpoint was the rate of 50% or more improvement in the patient's mean numerical rating scale pain score in the previous 24 hours, 14 days after starting the intervention. The secondary endpoint was the rate of change in the family caregivers' reaction assessments. RESULTS: A total of 75 patients and caregivers (70 patients with cancer and family caregivers) who received home medical care were enrolled at three facilities. The study completion rate was 94.7%, and there were no adverse events. The rate of 50% or more improvement in the numerical rating scale score was 64.0% in the ischemic compression group, 16.0% in the sham ischemic compression group, and 4.0% in the control group (P<0.001). Caregivers' self-esteem was significantly lower in the ischemic compression and sham ischemic compression groups than in the control group. However, there was no significant difference between the two groups (P=0.370). CONCLUSIONS: Ischemic compression for myofascial pain in patients performed by family caregivers can increase the analgesic effect in patients and self-esteem in family caregivers. TRIAL REGISTRATION: The University Hospital Medical Information Network Clinical Trials Registry (approval number: UMIN000036605).

Psychological Distress among Caregivers for Patients Who Die of Cancer: A Preliminary Study in Japan.

BACKGROUND: In Japan, little is known of the severity of and factors associated with psychological distress among caregivers of patients with advanced or recurrent cancer who die. METHODS: This prospective cohort study of cancer patients at the National Cancer Center Hospital East, Japan, and their caregivers followed the participants from the initial palliative care consultation (T1) to 6 months (T2) and 13 months (T3) after the patient's death. At T1, patients and caregivers were interviewed separately. After T1, telephone interviews were conducted periodically, and a mail survey was distributed at T2 and T3. The Patient Health Questionnaire-9 (PHQ-9) was used to assess depression, and the Distress and Impact Thermometer (DIT) was used to screen for psychological distress. Items on end-of-life attitudes, including awareness, discussion, and willingness of cancer care and death, were developed. RESULTS: Thirty-one of 86 eligible pairs participated in this study. The participation rate was low (36%) and enrollment was thus halted. Data were collected up to T3 for 22 pairs (completion rate 71%). PHQ-9 scores at T2 and T3 were higher than at T1, but the difference was not significant (p = 0.07). PHQ-9 score at T3 was significantly associated with caregiver PHQ-9 and distress at T1, with patient distress and impact at T1, and with caregiver health problems at T2. CONCLUSIONS: Caregiver depression persisted up to 13 months after the patient's death, which suggests that pre-bereavement screening with the DIT might be useful. The present paired enrollment process requires improvement.

Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol.

INTRODUCTION: Management of neuropathic cancer pain (NCP) refractory to regular opioids remains an important challenge. The efficacy of pregabalin for NCP except chemotherapy-induced peripheral neuropathy (CIPN) has already been confirmed in two randomised controlled trials (RCTs) compared with placebo. Duloxetine offers the potential of analgesia in opioid refractory NCP. However, there are no RCT of duloxetine for the management of opioid-refractory NCP as a first line treatment. Both classes of drugs have the potential to reduce NCP, but there has been no head-to-head comparison for the efficacy and safety, especially given differing side effect profiles. METHODS AND ANALYSIS: An international, multicentre, double-blind, dose increment, parallel-arm, RCT is planned. Inclusion criteria include: adults with cancer experiencing NCP refractory to opioids; Brief Pain Inventory (BPI)-item 3 (worst pain) of ≥4; Neuropathic Pain on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale of ≥12 despite of an adequate trial of regular opioid medication (≥60 mg/day oral morphine equivalent dose). Patients with CIPN are excluded.The study will recruit from palliative care teams (both inpatients and outpatients) in Japan and Australia. Participants will be randomised (1:1 allocation ratio) to duloxetine or pregabalin arm. Dose escalation is until day 14 and from day 14 to 21 is a dose de-escalation period to avoid withdrawal effects. The primary endpoint is defined as the mean difference in BPI item 3 for worst pain intensity over the previous 24 hours at day 14 between groups. A sample size of 160 patients will be enrolled between February 2020 and March 2023. ETHICS AND DISSEMINATION: Ethics approval was obtained at Osaka City University Hospital Certified Review Board and South Western Sydney Local Health District Human Research Ethics Committee. The results of this study will be submitted for publication in international journals and the key findings presented at international conferences. TRIAL REGISTRATION NUMBERS: jRCTs051190097, ACTRN12620000656932.