Mean Worst Pain Score Research Articles

Virtual reality for the management of pain and anxiety during outpatient manual vacuum aspiration for miscarriage or incomplete abortion: a mixed methods trial.

To evaluate the efficacy and acceptability of virtual reality (VR) as a distraction technique in the management of acute pain and anxiety during outpatient uterine aspiration using a manual vacuum aspirator (MVA). This mixed methods study included a prospective multi-centre randomised controlled trial and structured individual interviews. Of the 72 patients approached, 50 consenting, eligible participants were randomised to VR intervention (immersive video content 'The Forest of Serenity') or standard care during MVA for the management of miscarriage or incomplete abortion from July 2021-July 2022 across two university hospitals in London, UK. Expected and actual pain scores, and anxiety before and after the procedure were measured as numeric rating scores (0-10). Structured interviews were undertaken after the procedure in women randomised to VR. Statistical analysis of pain and anxiety scores were by intention-to-treat including all randomised participants, using Stata-12 software. Qualitative analysis was achieved by thematic analysis of transcribed interviews. There was no significant difference in pain or anxiety scores reported by participants randomised to VR compared with standard care. Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively (p-value 0.13), with corresponding anxiety scores at the end of the procedure 3.94 and 3.3 (p-value 0.57). Qualitative analysis from interviews was highly favourable from women randomised to VR with all participants reporting a positive experience. 90% (18/20) of participants reported that VR reduced their anxiety and 71% (15/21) stated that it helped to reduce or distract from their pain. While virtual reality did not decrease pain or anxiety scores during MVA, it is a feasible and acceptable option that may improve patient experience. Randomisation to VR during MVA did not reduce pain or anxiety scores. However, at structured interview most participants reported that VR reduced their anxiety and reduced or distracted them from their pain. VR is a feasible and acceptable option that may improve patient experience during MVA.

Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo.

Although a single-injection interscalene block provides effective early postoperative analgesia following shoulder surgery, patients may experience "rebound pain" when the block resolves. Our objective was to determine if oral hydromorphone (2 mg) given six hours after a single-injection interscalene block for arthroscopic shoulder surgery leads to a clinically significant reduction in the severity of rebound pain. After approval from research ethics boards, we conducted a two-centre, parallel-group, double-blind, randomized, placebo-controlled superiority trial. Patients received preoperative interscalene block, general anesthesia, and either hydromorphone or placebo six hours after the block. The primary outcome was the worst pain score in the first 24 hr postoperatively, measured on an 11-point (0-10) numerical rating scale. A total of 73 participants were randomly assigned to either the hydromorphone or placebo group. There was no statistically significant difference in the mean (standard deviation) worst pain score within 24 hr between the hydromorphone and placebo groups (6.5 [2.4] vs 5.9 [2.3]; mean difference, 0.6; 95% confidence interval, -0.5 to 1.8). Similarly, we did not find any significant difference in the pain trajectory, opioid use, or incidence of nausea and vomiting between the groups. The mean time to worst pain was 14.6 hr, and the mean time to first rescue analgesia was 11.3 hr after interscalene block. Hydromorphone 2 mg given six hours after interscalene block did not reduce the severity of rebound pain postoperatively compared with placebo in patients undergoing arthroscopic shoulder surgery. ClinicalTrials.gov (NCT02939209); registered 19 October 2016.

Effect of melatonin on paclitaxel-associated acute and chronic pain: a randomized, double-blind, placebo-controlled clinical trial

Background: Taxane-induced pain is a disabling condition. This trial was conducted to assess the effects of melatonin on preventing paclitaxel-associated acute and chronic pain or decreasing its severity in patients with breast cancer. Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted on breast cancer women who received weekly paclitaxel (80 mg/m2) with or without trastuzumab after using doxorubicin + cyclophosphamide. The intervention group randomly received oral melatonin (10 mg/day) or placebo, which started from the first night of chemotherapy and continued through the planned 12 weeks of chemotherapy. The level of arthralgia-myalgia as acute pain was assessed every day in both groups using the Brief Pain Inventory (BPI). The Douleur Neuropathique 4 questionnaire (DN4) and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 were used to measure chemotherapy-induced peripheral neuropathy as chronic pain. Results: Seventeen patients were enrolled in each group randomly. The incidence of neuropathy according to a DN4 score ≥ 4 was significantly lower in the melatonin group versus the placebo group at week 12 compared to baseline (5 vs 11, P-value= 0.039). In addition, the mean neuropathy severity was significantly lower in the melatonin group over time (β= -0.051, P-value= 0.01). However, there were no significant differences in the mean worst and least pain scores over the twelve cycles of treatment between arms (P-value= 0.633, 0.341 respectively). Conclusion: Co-administration of melatonin in women with breast cancer decreased the incidence of severe paclitaxel-associated neuropathy but melatonin was not effective against acute pain.

Adherence to treatment and prevalence of side effects when medical abortion is delivered via telemedicine: a prospective observational cohort study during COVID-19

BackgroundThe Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we...

Gabapentin to reduce pain in women aged between 18 and 50 years with chronic pelvic pain: the GaPP2 RCT

BackgroundChronic pelvic pain affects 2–24% of women worldwide, and evidence for medical treatments is limited. Gabapentin is effective in treating some chronic pain conditions, but its effect on central pain processing is unknown.ObjectivesTo test the hypothesis that gabapentin can reduce pain and improve physical and emotional functioning in women with chronic pelvic pain. We investigated the mechanism of action of gabapentin in a subset of women.DesignA randomised, double-blind, placebo-controlled, multicentre trial with a brain imaging substudy.SettingThis trial took place in 39 UK hospitals.ParticipantsA target of 300 women with a history of chronic pelvic pain in whom a laparoscopy revealed no obvious pelvic pathology.InterventionWomen were randomised to receive 300 mg of gabapentin (which was escalated to a maximum of 2700 mg daily) or a matched placebo over a 4-week dose-escalation period, followed by 12 weeks on optimal dose. A mechanistic substudy was also undertaken, in which a subset of participants had a functional magnetic resonance imaging scan of their brain before and following 16 weeks of treatment.Main outcome measuresThe dual primary measure of the worst and average pelvic pain scores was assessed weekly by a numerical rating scale (0–10) in weeks 13–16 post randomisation. The secondary outcomes were patient-reported questionnaires, assessed physical functioning, fatigue, psychological health, sexual activity, work and productivity, and pain catastrophising. Health-care resource use, analgesic use and adverse events were also collected. The main outcome measure for the mechanistic study was brain activity at rest and in response to noxious stimuli.ResultsIn the main trial, 306 participants were randomised. The mean worst pain score was 7.1 (standard deviation 2.6) in the gabapentin group and 7.4 (standard deviation 2.2) in the placebo group (adjusted mean difference –0.20, 97.5% confidence interval –0.81 to 0.42;p = 0.47). The mean average pain score was 4.3 (standard deviation 2.3) in the gabapentin group and 4.5 (standard deviation 2.2) in the placebo group (adjusted mean difference –0.18, 97.5% confidence interval –0.71 to 0.35;p = 0.45). No significant between-group differences were observed for any secondary outcome. A higher proportion of women experienced a serious adverse event in the gabapentin group than in the placebo group (10/153 vs. 3/153;p = 0.04). Dizziness, drowsiness and visual disturbances were more common in the gabapentin group than in the placebo group. In the mechanistic study, 45 participants had a baseline functional magnetic resonance imaging scan of their brain, with 25 participants returning for a scan at the end of treatment. Gabapentin significantly decreased evoked activity in the anterior cingulate cortex and cuneus. Change in anterior cingulate cortex activity after treatment related to improvement on the pain interference scale, and baseline activation of this region predicted response to treatment.ConclusionsGabapentin did not reduce pain and did not improve other outcomes compared with placebo over 16 weeks. Serious adverse effects were significantly higher in the gabapentin group than in the placebo group. Gabapentin reduces evoked activity in the anterior cingulate cortex, with changes of activity in this region tracking reported pain, and baseline activity predicting response to treatment.LimitationsPrimary outcome data were unavailable in 62 and 60 women for the average and worst numerical rating scale pain scores, respectively. A sensitivity analysis using imputation methods did not change the result.Future workClinical trials to investigate other pharmacological interventions (monotherapy vs. combination therapy), physiotherapy and cognitive–behavioural therapy to treat women with chronic pelvic pain are needed.Trial registrationCurrent Controlled Trials ISRCTN77451762 and EudraCT 2014-005035-13.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 7, No. 7. See the NIHR Journals Library website for further project information.

Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients

PurposeTo evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases. Materials and MethodsOne hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects’ pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected. ResultsEighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n = 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P < .0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure. ConclusionsResults from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy.

BackgroundTo estimate the health care resource utilization, costs, and impact on quality of life (QoL) of herpes zoster (HZ) and postherpetic neuralgia (PHN) in adults aged ≥50 years in Italy.MethodsThis was a prospective, observational, multicenter, community physician–based surveillance study (NCT01772160) in Italy. Health-related QoL data were collected using the EuroQoL-5 Dimension (EQ-5D) and Zoster Brief Pain Inventory (ZBPI) questionnaires. Both questionnaires were assessed at days 0 (HZ rash onset), 15, 30, 60, and 90 for all patients, and monthly thereafter for patients who developed PHN. Resource utilization was recorded for 3 months post–HZ onset and 9 months for PHN patients. Costs from both payer and societal perspectives were estimated and were composed of direct medical costs (general practitioner/specialist visits, procedures, hospitalizations, medications), work loss by patient/caregiver, and transport costs.ResultsA total of 391 patients with HZ were included, of whom 40 developed PHN. The mean ZBPI worst pain score was 5.7 at day 0, reducing to 2.6 at day 30 and 0.7 by day 90. Patients with PHN had a mean worst pain score of 5.7 at day 90. We estimated an overall disutility associated with HZ of 0.134. The mean cost per HZ patient from a payer/societal perspective was €153/€298, respectively, and the mean cost per HZ patients who developed PHN was €176/€426, respectively.ConclusionsHZ is associated with impaired QoL and substantial health care resource use, highlighting the need for preventive strategies. This could reduce the disease burden for the patient and health care system.ClinicalTrials.gov study registryNCT01772160.

Clinical outcomes and risk factors in patients with cervical metastatic spinal cord compression after posterior decompressive and spinal stabilization surgery.

PurposeThe aim of this study was to investigate the clinical results of surgery for cervical spine metastasis and identify clinical risk factors affecting postoperative survival and neurological outcome.Patients and methodsA retrospective analysis of medical records was performed on 19 patients who had undergone decompressive surgery and spine stabilization due to metastatic spinal cord compression in the cervical spine. All patients had severe pain before surgery. Worst pain, average pain, and pain interference were evaluated using the visual analog scale (range, 0–10) for each patient at baseline and following surgery. Neurological recovery was assessed using the Japanese Orthopaedic Association Score (JOAS). In addition, associations between ten characteristics and postoperative survival and neurological outcomes were analyzed in the study.ResultsThe mean worst pain score in a 24-hour period was 8.6 before the operation. At 1 day, 1, 3, 6, and 12 months after the operation, the mean worst pain scores decreased to 5.6, 4.5, 3.8, 2.6, and 2.4 (all P<0.001 vs baseline), respectively. Similar decreases in average pain and pain interference were also observed. The median JOAS in a 24-hour period was 11.0 before the operation. At 1 day, 1, 3, 6, and 12 months after the operation, the median JOAS increased to 12.0 (P=0.469), 13.0 (P=0.010), 14.0 (P<0.001), 15.0 (P<0.001), and 14.0 (P<0.001), respectively. According to the multivariate analysis, postoperative survival was significantly associated with the type of primary tumor (P=0.033), preoperative ambulatory status (P=0.004), extra-spinal bone metastasis (P=0.021), 125I seed brachytherapy (P=0.014), and complication status (P=0.009). Better neurological outcome was found to be correlated with higher JOAS (P=0.013). Surgery-related complications occurred in 26.3% of patients.ConclusionPosterior decompression and spine stabilization for painful cervical spine metastasis resulting from spinal cord compression were found to be effective for neurological recovery and pain control with a tolerable rate of complications.

PSY196 - THE ECONOMIC BURDEN AND IMPACT ON QUALITY OF LIFE OF HERPES ZOSTER AND POSTHERPETIC NEURALGIA IN INDIVIDUALS AGED 50 YEARS OR OLDER IN ITALY

To estimate the impact on quality of life (QoL), the health care resource utilization and costs of Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) in adults aged ≥50 years in Italy. This was a prospective, observational, multi-centre, community-physician based study in Italy (NCT01772160). 391 subjects with HZ were included, 40 of whom developed PHN. Health related QoL data were collected using the EuroQoL5D (EQ-5D) and Zoster Brief Pain Inventory (ZBPI) questionnaires. Both questionnaires were assessed at day: 0 (HZ rash onset), 15, 30, 60, 90 for all subjects and then once every 30 days for subjects who developed PHN. Resource utilization was recorded for 3 months post HZ onset and for 9 months for PHN subjects. Costs from both a payer and societal perspective were estimated and were composed of direct medical costs (physician and specialist visits, procedures, hospitalisations, medications), productivity loss by subject/caregiver and transportation costs. For all HZ subjects the mean ZBPI worst pain score (Scale 0-10) was 5.7 at day 0, reducing to 2.6 at day 30 and 0.7 by day 90. Subjects with PHN had a mean worst pain score of 5.7 at day 90. We estimated a mean disutility associated with acute HZ (i.e. Day 0-30) of 0.134. A mean of 2.2 Physician and 0.14 specialist visits were observed per subject while 7 subjects required hospitalisation. The mean cost per HZ episode from a payer/societal perspective was €153/298, and €176/426 for subjects who developed PHN. The highest combined costs were observed in subjects with ocular complications. Medications accounted for 58% of the total direct medical cost. HZ and its related complications are associated with impaired QoL and substantial health care resource use. This highlights the need for preventive strategies to reduce the disease burden for patients and health care systems.

Surgical results and clinical risks of postoperative complications in patients with painful malignant spinal cord compression after decompressive surgery.

IntroductionThis study aims to analyze clinical outcome in patients with painful malignant spinal cord compression due to advanced cancers after the decompressive surgery and identify risk factors for postoperative complications in these patients. Furthermore, we created a scoring model to predict the risk of postoperative complications based on identified significant risk factors.MethodsWe retrospectively analyzed survival outcomes, pain outcomes, and postoperative complications of patients with painful malignant spinal cord compression who were surgically treated in our department. Identification of risk factors for postoperative complications was also performed, and significant factors according to the multiple logistic regression models were included in the scoring model.ResultsAs a result, 105 patients were enrolled. The overall median survival time was 9.1 months (95% CI, 7.1–11.4 months). The mean worst pain score was 8.0 in a 24-hour period before surgery, while it decreased to 6.0, 5.0, 3.5, 3.3, and 3.6 (all P<0.01, when compared with baseline date) at 1 week, 1 month, 3, 6, and 12 months after surgery, respectively. Similar decreases were also observed in the average pain and the pain interference. Thirty-one complications occurred within 4 weeks after operation in 26 patients (24.8%, 26/105). Based on multiple logistic regression models, age (P=0.03), Karnofsky performance status (P<0.01), and Charlson Comorbidity Index (P=0.04) were significantly associated with postoperative complications and were included in the scoring model. Three risk groups were created based on the complication rates of each scoring points. The corresponding postoperative complication rates of the three groups were 7.7% in group A (0–3 points), 26.7% in group B (4–6 points), and 60.9% in group C (7–10 points), respectively (OR, 4.32, 95% CI: 2.24–8.31, P<0.01).ConclusionDecompressive surgery for painful malignant spinal cord compression was found to be useful for pain control with a tolerable rate of complications. We created a scoring model to predict the risk of postoperative complications in patients with painful malignant spinal cord compression after surgery. This scoring model may guide doctors to choose the appropriate care strategies to realize better pain management.

Chinese Medicine Yishen Jiangu Granules () on Aromatase Inhibitor-Associated Musculoskeletal Symptoms.

To assess the effectiveness of Yishen Jiangu Granules (, YSJGG) on aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). A single-arm, open-label study was conducted in 34 postmenopausal women with breast cancer who experienced AIMSS. Patients were treated with YSJGG for 12 weeks (12.4 g orally twice daily). The primary outcome was a change in the mean worst pain score of Brief Pain Inventory-Short Form (BPI-SF) over 12 weeks, and the second outcomes included changes in pain severity and pain-related interference of BPI-SF and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Breast (FACT-B), bone mineral density (BMD) and blood indices such as calcium (Ca), phosphate (P), and alkaline phosphatase (ALP). Of 37 women recruited, 30 initiated the therapy and 24 were evaluable at 12 weeks. The primary outcome (BPI-SF worst pain scores) achieved a 2.17-point reduction compared with baseline (5.75±1.87 vs 3.58±2.15, P<0.01). There were reductions in pain severity (decreased 1.65, P<0.01) and pain-related interference (decreased 2.55, P<0.01). The changes in WOMAC and M-SACRAH scores were similar to BPI-SF (P<0.05). In the FACT-B, only physical well-being and functional well-being were improved compared with baseline (P<0.05). No clinical differences were found in BMD, Ca, P and ALP. YSJGG is an effective and well-tolerated agent to reduce AIMSS.

Patterns of missing data in the use of the endometriosis symptom diary

BackgroundEndometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported outcome (ePRO) instrument that assesses women’s experience of endometriosis symptoms, with pain scored using a 0–10 numeric rating scale. This study investigated patterns of data missing from the ESD in the VALEPRO study.MethodsPost hoc analyses of missing data were conducted.ResultsOf 272 participants using the ESD, 26.5% had no missing diary entries, 46.7% had > 0–5% of entries missing, 13.2% had > 5–10% of entries missing and 13.6% had > 10% of entries missing over the entire study period. The duration of missing episodes (defined as ≥1 consecutive days with missing diary entries) was generally short; most (81.4%) were 1 day. The difference in mean worst pain scores between missing and complete episodes per participant was − 0.1, suggesting that missing episodes were not related to severity of pain. Entries were significantly more likely to be missing on Fridays (18.5%) and Saturdays (22.9%) compared with other days of the week (p < 0.0001). Participants in the USA had significantly more long missing episodes than those in Germany (proportions of missing episodes longer than 1 day, 22.6 and 10.5%, respectively; p < 0.0001). The proportions of women with ≥1 missing entry were 50.0, 70.2 and 79.8% for women with elementary education, secondary education, and a college or university education, respectively. The proportions of women with ≥1 missing entry were similar for those with and without children (72.2 and 74.3%, respectively).ConclusionsMost participants were highly compliant with entering data in the ESD and the amount of missing data was low. Entries were significantly more likely to be missing on Fridays and Saturdays compared with other days of the week, and participants in the USA had significantly more long missing episodes than participants in Germany.Trial registrationClinicaltrials.gov, NCT01643122, registered 4 July 2012.

Measuring herpes zoster disease burden in São Paulo, Brazil: a clinico-epidemiological single-center study

OBJECTIVES:Herpes zoster is characterized by acute neuritis and post-herpetic neuralgia. Currently, data concerning the zoster-associated impact on quality of life and healthcare resource utilization in Brazil are scarce. This study measured the zoster-associated burden in a Brazilian population.METHODS:This was a prospective, observational, single-cohort study conducted in a primary hospital’s emergency room in São Paulo, Brazil. Patients enrolled at various timepoints during a zoster episode were followed over 180 days. The Zoster Brief Pain Inventory and the Initial Zoster Impact Questionnaire assessed zoster-associated pain. The EuroQoL assessed the impact of herpes zoster and/or zoster-associated pain on quality of life. Healthcare resource utilization was assessed by patient-reported questionnaires.RESULTS:One-hundred forty-six zoster patients were enrolled [mean (SD) age of 69.9 (10.9) years]. Mean (SD) worst pain scores decreased from 5.3 (3.5) at baseline to 1.9 (3.0) 180 days following rash onset. Mean (SD) EuroQoL scores significantly decreased from 0.9 (0.2) before rash appearance to 0.7 (0.2) after rash onset (p<0.001), followed by gradual improvements in quality of life over 180 days, with pre-herpes zoster quality of life achieved at the end of the observation period. The majority of patients purchased prescription medications (89.7%) and required doctor’s office visits (65.8%) for zoster episodes.CONCLUSIONS:Herpes zoster is associated with a significant disease burden, including zoster-associated pain, impaired quality of life and increased healthcare resource utilization in Brazil. These results support the implementation of early intervention and prevention programs such as vaccinations to reduce the herpes zoster-associated disease burden in Brazil.

Percutaneous Ultrasound-Guided Cryoablation for Symptomatic Plantar Fibromas.

Here, we report our experience in treating painful plantar fibromas with percutaneous cryoablation. We retrospectively identified patients with symptomatic plantar fibromas who underwent percutaneous ultrasound-guided cryoablation between June 2014 and June 2015. In total, four patients (two male, two female) with five plantar fibromas undergoing a total of seven ablation procedures were identified. Each procedure was performed under general anesthesia using a single freeze-thaw cycle. The electronic medical record, procedure reports, and pain scores from a brief pain inventory administered before and after treatment were reviewed. Average and worst pain in 24h, and time to peak symptom improvement post-procedure were compared. Complications were reviewed using the SIR classification. Five plantar fibromas were treated (mean size 2.2±1.6cm). Four of five lesions were present for more than 6years, and 1/5 was present for less than 1year. Surgical excision was previously performed on 3/5 lesions, all with short-term recurrence. Mean worst pain score in 24h and average pain score in 24h (scale of 10) at initial evaluation were 7.1±1.8 and 5.8±1.9, reduced after cryoablation to 0.8±0.8 and 0.4±0.6, respectively. Average time to symptom improvement was 2.8±0.98weeks (range 2-4weeks). All patients reported improved ambulation and weight-bearing, and complete cessation of pain medication after treatment. The improvement was sustained on follow-up at 12months. No major complications occurred. Minor complications occurred in 3/5 patients. Early experience with percutaneous ultrasound-guided cryoablation to treat painful plantar fibromas suggests that it is a safe and effective treatment option, with early and near-complete symptom improvement.

Impact of symptomatic skeletal events on health-care resource utilization and quality of life among patients with castration-resistant prostate cancer and bone metastases.

Data regarding the impact of symptomatic skeletal events (SSEs) on health economics and patient-reported outcomes in men with castration-resistant prostate cancer (CRPC) and bone metastases from a clinical setting are lacking. Hence, this study aimed to quantify the effects of SSEs on health-care resource utilization (HRU), health-related quality of life (HRQoL) and pain in men with CRPC metastasized to bone. This cohort study included men with CRPC and bone metastasis treated at a tertiary center during December 1996-July 2015. SSEs, including pathological fracture, radiation to bone, spinal cord compression and bone surgery, as well as HRU were identified retrospectively through medical records and clinical database. A subset of surviving patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires. The incremental effect of SSEs on HRU was evaluated using multivariable generalized linear regression. Questionnaire scores were compared using effect sizes (ES); ES⩾0.33 indicated meaningful differences between SSE and non-SSE cohorts. Lower scores suggest lower HRQoL and pain. Of the 832 patients, 207 developed ⩾1 SSE (mean 1.5±0.8) during follow-up (median 2.1 years). Radiation to bone was the most common SSE (84.1%). SSE cohort had significantly higher emergency room (incidence rate ratio (IRR)=1.48; P=0.006), outpatient (IRR=1.17; P=0.005) and inpatient (IRR=1.74; P<0.001) visits. Of the 107 eligible survey patients, 103 (96.3%) responded. SSE cohort had lower mean FACT-P functional well-being (17.5 vs 19.8; P=0.158; ES=0.36), higher mean pain severity (2.5 vs 1.6; P=0.048; ES=0.47) and worst pain scores (3.6 vs 2.3; P=0.033; ES=0.50) compared with the non-SSE cohort, indicating meaningful differences between cohorts. This study demonstrated high economic and HRQoL burden of SSEs. The findings underscore the need for better supportive and disease-modifying treatments for these patients.

Management of acute skin toxicity with Hypericum perforatum and neem oil during platinum-based concurrent chemo-radiation in head and neck cancer patients.

Acute skin toxicity is a frequent finding during combined radiotherapy and chemotherapy in head and neck cancer patients. Its timely and appropriate management is crucial for both oncological results and patient's global quality of life. We herein report clinical data on the use of Hypericum perforatum and neem oil in the treatment of acute skin toxicity during concurrent chemo-radiation for head and neck cancer. A consecutive series of 50 head and neck cancer patients undergoing concomitant radio-chemotherapy with weekly cisplatin was analyzed. Treatment with Hypericum perforatum and neem oil was started in case of G2 acute skin toxicity according to the RTOG/EORTC scoring scale and continued during the whole treatment course and thereafter until complete recovery. The maximum detected acute skin toxicity included Grade 2 events in 62% of cases and G3 in 32% during treatment and G2 and G3 scores in 52 and 8%, respectively, at the end of chemo-radiation. Grade 2 toxicity was mainly observed during weeks 4-5, while G3 during weeks 5-6. Median times spent with G2 or G3 toxicity were 23.5 and 14days. Patients with G3 toxicity were reconverted to a G2 profile in 80% of cases, while those with a G2 score had a decrease to G1 in 58% of cases. Time between maximum acute skin toxicity and complete skin recovery was 30days. Mean worst pain score evaluated with the Numerical Rating Scale-11 was 6.9 during treatment and 4.5 at the end of chemo-radiotherapy. Hypericum perforatum and neem oil proved to be a safe and effective option in the management of acute skin toxicity in head and neck cancer patients submitted to chemo-radiation with weekly cisplatin. Further studies with a control group and patient-reported outcomes are needed to confirm this hypothesis.

Radiofrequency ablation versus 125I-seed brachytherapy for painful metastases involving the bone.

This retrospective study aimed to demonstrate and compare the safety and effectiveness of computed tomography-guided radiofrequency ablation (RFA) and 125I-seed brachytherapy for painful bone metastases after failure of external beam radiotherapy (EBRT). From June 2013 to October 2015, 79 patients with moderate-to-severe pain caused by metastatic bone lesions who underwent either RFA (n = 41) or 125I-seed brachytherapy (n = 38) were enrolled. Pain in patients was measured using the brief pain inventory (BPI) before treatment, 1 week after treatment, and 3 months after treatment. Response rates were assessed by measuring the changes in pain and incorporation of changes in the analgesic requirements. At baseline, 1 week, and 3 months, the mean worst pain scores of BPI were 7.8, 5.4, and 2.7, respectively, for the RFA group and 7.7, 6.1, and 2.8, respectively, for the brachytherapy group. At 1 week, the complete and partial response rates were 12% and 59%, respectively, in the RFA group compared with 3% and 45%, respectively, in the brachytherapy group. At 3 months, the complete and partial response rates were 23% and 58%, respectively, in the RFA group compared with 24% and 52% in the brachytherapy group (p = 0.95). The response rates in the RFA group were significantly higher than those in the brachytherapy group at 1 week (p = 0.32), but comparable at 3 weeks (p = 0.95). Both groups had low rates of complications and no treatment-related mortality. In conclusion, the short-term curative efficiency of RFA was better than that of brachytherapy, but the log-term efficiency of both treatments was equal.

Combined Ablation and Radiation Therapy of Spinal Metastases: A Novel Multimodality Treatment Approach

Background: Radiation therapy (RT) is the current gold standard for palliation of painful vertebral metastases. However, other percutaneous modalities such as radiofrequency ablation (RFA), cryoablation, and vertebral augmentation have also been shown to be effective in alleviating symptoms. Combined RT and ablation may be more effective than either therapy alone in palliating painful metastatic disease to the spine. Objective: To evaluate the safety and efficacy of combined ablation, either RFA or cryoablation, and RT in the treatment of spinal metastases. Study Design: Retrospective study. Setting: This is a retrospective study at a single institution. Methods: Medical records of all patients who underwent ablation of spine lesions at a single institution between March 2012 and June 2014 were reviewed; patients treated with both RT and either RFA or cryoablation concurrently were identified. Pain scores before and after RFA were measured with the numerical rating scale (NRS) (0 – 10 point scale) and compared. Procedural complications, changes in general activity level, and pain medication usage after ablation were also recorded. When available, follow-up imaging was evaluated for evidence of residual or recurrent disease. Results: Twenty-one patients with 36 spine metastases were treated with RT and percutaneous ablation concurrently; either RFA (21/22) or cryoablation (1/22). One patient received 2 separate RFA treatments. Overall, mean worst pain score (8.0, SD = 2.3) significantly decreased at both one week (4.3, SD = 3.1; P &lt; .02) and 4 weeks (2.9, SD = 3.3; P &lt; .0003). Temporary postprocedural radicular pain occurred after one RFA treatment (4.5%; 1/22). Seven patients had radiation resistant tumors (renal cell, melanoma, or sarcoma). Post-procedural imaging (median 6 months; range 2 – 27 months) showed stable treated disease in 12/13 treatments at 3 months and 10/10 at 6 months. Limitations: The therapeutic effect of vertebral augmentation versus percutaneous ablation cannot be separated in this retrospective study. Radiation treatment protocols were variable and included both stereotactic body and conventional RT which may have different safety and efficacy profiles. Conclusion: Percutaneous ablation and concurrent RT is safe and effective in palliating painful spinal metastases and can be effective in those who have radiation resistant tumor histology. Key words: Interventional spine oncology, pain, percuataneous ablation, radiofrequency ablation, cryoablation, radiation therapy, spine metastases, vertebroplasty

Effects of the education program for patients with cancer pain.

193 Background: Caner pain is prevalent, burdensome, and undertreated. Barriers to good cancer pain control exist within patients on lack of knowledge or poor attitudes towards pain and opioid analgesics. The objective of this study was to test the effects of an education program on reducing barriers to pain management in oncology. Methods: Participants completed baseline assessments and were randomly allocated to receive an education program or not in addition to standard care. Education materials for the pain management program included the ‘Guideline on cancer pain management for patients’. The average education time took basically 30 minutes, and CRNs implemented the education program using a booklet for an individual patient. Outcome measures at one week included the Barriers Questionnaire (BQ), Brief Pain Inventory. Adherence of analgesia and daily activity score were assessed. Results: 176 participants were recruited from 5 sites over 3 months. Mean average pain and worst pain score (NRS) improved significantly in patients receiving education program 1.40 and 1.61. The addiction subscale of the BQ score was improved by 1.95 (pre: 3.39, post: 1.44, p &lt; 0.001) for participants receiving pain education. In terms of administration of short-acting analgesics due to breakthrough pain, inpatients showed no large difference before/after education in the use of short-acting analgesics but outpatients exhibited an increase from 25.5% before education to 73.5% after education and the difference was statistically significant. Conclusions: A cancer pain education was effective in reducing patient's barriers to pain management, improving pain score and daily activity score of cancer patients, especially using short-acting analgesics for breakthrough pain control in outpatients.

Radiofrequency ablation and vertebral augmentation for palliation of painful spinal metastases.

Radiofrequency ablation (RFA) and vertebral augmentation is an emerging combination therapy for painful osseous metastases that cannot be or are incompletely palliated with radiation therapy. Herein, we report our experience performing RFA and vertebral augmentation of spinal metastases for pain palliation. Institutional review board approval was obtained to retrospectively review our tumor ablation database for all patients who underwent RFA of osseous metastases between April 2012 and July 2014. Patient demographics, lesion characteristics, concurrent palliative therapies, and complications were recorded. Pre- and post-procedure mean worst pain scores 1 and 4weeks after treatment were measured using the Numeric Rating Scale (10-point scale) and compared. During the study period, 72 RFA treatments of 110 spinal metastases were performed. Eighty one percent (89/110) of metastases involved the posterior vertebral body and 45% (49/110) involved the pedicles. Vertebral augmentation was performed after 95% (105/110) of ablations. Mean and median pre-procedure pain scores were 8.0±1.9 and 8.0, respectively. Patients reported clinically significant decreased pain scores at both 1-week (mean, 3.9±3.0; median, 3.25; P<0.0001) and 4-week (mean, 2.9±3.0; median, 2.75; P<0.0001) follow-up. No major complications occurred related to RFA and there were no instances of symptomatic cement extravasation. CombinationRFA and vertebral augmentationis a safe and effective therapy for palliation of painful spinal metastases, including tumor involving the posterior vertebral body and/or pedicles.