Evidence-Based Role of Nutrients and Antioxidants for Chronic Pain Management in Musculoskeletal Frailty and Sarcopenia in Aging.

Musculoskeletal disorders in aging and pain are closely connected because of multiple mechanisms leading to loss of mobility and autonomy. Pain is predictive of diability and worsening frailty and the strength of this relationship increases with the severity of pain. This study presents a systematic review of randomized controlled trials, cross sectional studies, and observational studies based on treatment of pain in adults with musculoskeletal disorders using nutritional non-pharmacological (nutrients and antioxidants) interventions. The review found the efficiency of the following topics: (a) accession of the patient to a dietary counselling (e.g., daily recommended amount of protein-equivalent to at least of 1 g of protein per kilogram of body weight); (b) intake of glutamic acid-rich such as soy, egg, and cod and tryptophan-rich foods such as milk and peanuts-or taking quick-acting, free-form supplements; (c) supplementation of vitamin D and magnesium, if lacking; (d) weekly consumption of fish or supplements of omega-3 fatty acids; and (e) availability of botanicals, in particular curcumin and gingerol. These non-pharmacological interventions can help the pain therapist to create a personalized medicine (precision medicine), acting with the maximum efficacy and safety, and also reducing the dosage of analgesic drugs needed.

Linking Persistent Pain and Frailty in Older Adults.

OBJECTIVE: In older adults, the impact of persistent pain goes beyond simple discomfort, often contributing to worsening functional outcomes and ultimately frailty. Frailty is a geriatric syndrome that, like persistent pain, increases in prevalence with age and is characterized by a decreased ability to adapt to common stressors such as acute illness, thereby increasing risk for multiple adverse health outcomes. Evidence supports a relationship between persistent pain and both the incidence and progression of frailty, independent of health, social, and lifestyle confounders. DESIGN AND SETTING: In this article, we synthesize recent evidence linking persistent pain and frailty in an effort to clarify the nature of the relationship between these two commonly occurring geriatric syndromes. SETTING: We propose an integration of the frailty phenotype model by considering the impact of persistent pain on vulnerability toward external stressors, which can ultimately contribute to frailty in older adults. RESULTS AND CONCLUSIONS: Incorporating persistent pain into the frailty construct can help us better understand frailty and ultimately improve care for patients with, as well as those at increased risk for, pain and frailty.

Food pyramid for subjects with chronic pain: foods and dietary constituents as anti-inflammatory and antioxidant agents.

Emerging literature suggests that diet constituents may play a modulatory role in chronic pain (CP) through management of inflammation/oxidative stress, resulting in attenuation of pain. We performed a narrative review to evaluate the existing evidence regarding the optimum diet for the management of CP, and we built a food pyramid on this topic. The present review also describes the activities of various natural compounds contained in foods (i.e. phenolic compounds in extra-virgin olive oil (EVO)) listed on our pyramid, which have comparable effects to drug management therapy. This review included 172 eligible studies. The pyramid shows that carbohydrates with low glycaemic index should be consumed every day (three portions), together with fruits and vegetables (five portions), yogurt (125 ml), red wine (125 ml) and EVO; weekly: legumes and fish (four portions); white meat, eggs and fresh cheese (two portions); red or processed meats (once per week); sweets can be consumed occasionally. The food amounts are estimates based on nutritional and practical considerations. At the top of the pyramid there is a pennant: it means that CP subjects may need a specific customised supplementation (vitamin B12, vitamin D, n-3 fatty acids, fibre). The food pyramid proposal will serve to guide dietary intake with to the intent of alleviating pain in CP patients. Moreover, a targeted diet can also help to solve problems related to the drugs used to combat CP, i.e. constipation. However, this paper would be an early hypothetical proposal due to the limitations of the studies.

Beyond Body Mass Index. Is the Body Cell Mass Index (BCMI) a useful prognostic factor to describe nutritional, inflammation and muscle mass status in hospitalized elderly?: Body Cell Mass Index links in elderly.

BACKGROUND & AIM: The aim of this study was to establish the effectiveness of Body Cell Mass Index (BCMI) as a prognostic index of (mal)nutrition, inflammation and muscle mass status in the elderly. METHODS: A cross-sectional observational study has been conducted on 114 elderly patients (80 women and 34 men), with mean age equal to 81.07 ± 6.18 years. We performed a multivariate regression model by Structural Equation Modelling (SEM) framework. We detected the effects over a Mini Nutritional Assessment (MNA) stratification, by performing a multi-group multivariate regression model (via SEM) in two MNA nutritional strata, less and bigger (or equal) than 17. RESULTS: BCMI had a significant effect on albumin (ß = +0.062, P = 0.001), adjusting for the other predictors of the model as Body Mass Index (BMI), age, sex, fat mass and cognitive condition. An analogous result is maintained in MNA<17 stratum. BMI has confirmed to be a solid prognostic factor for both free fat mass (FFM) (ß = +0.480, P < 0.001) and Skeletal Muscle Index (SMI) (ß = +0.265, P < 0.001), assessed by DXA. BCMI also returned suggestive evidences (0.05 < P < 0.10) for both the effect on FFM and on SMI in overall sample. CONCLUSIONS: The main result of this study is that the BCMI, compared to BMI, proved to be significantly related to an important marker as albumin in geriatric population. Then, assessing the BCMI could be a valuable, inexpensive, easy to perform tool to investigate the inflammation status of elderly patients.

Guidance on opioids prescribing for the management of persistent non-cancer pain in older adults.

Many older adults suffer from persistent pain but prevalence studies consistently showed high levels of untreated or under-treated pain in old population. Both persistent pain and pain under-treatment adversely affect independence and quality of life in geriatric patients. Pain management is challenging in this age-group because of the declining organ function, the presence of concurrent diseases and polypharmacy. For all the above reasons, persistent pain in the elderly should be considered a geriatric syndrome per se and effective approaches are warranted. Current guidelines and consensus statements recommend opioid therapy for older adults with moderate-to-severe persistent pain or functional impairment and diminished quality of life due to pain. However clinicians and patients themselves have some concerns about opioids use. Age-related decline in organs functions and warnings about risk of addiction and drug misuse/abuse also in geriatric patients need particular attention for safe prescribing. On the basis of clinical evidence, these practical recommendations will help to improve the competence on opioid role in persistent pain management and the likelihood of a successful analgesic trial in older patients.

Performance of Edmonton Frail Scale on frailty assessment: its association with multi-dimensional geriatric conditions assessed with specific screening tools.

BACKGROUND: The aim of this study was to evaluate the performance of Edmonton Frail Scale (EFS) on frailty assessment in association with multi-dimensional conditions assessed with specific screening tools and to explore the prevalence of frailty by gender. METHODS: We enrolled 366 hospitalised patients (women\men: 251\115), mean age 81.5 years. The EFS was given to the patients to evaluate their frailty. Then we collected data concerning cognitive status through Mini-Mental State Examination (MMSE), health status (evaluated with the number of diseases), functional independence (Barthel Index and Activities Daily Living; BI, ADL, IADL), use of drugs (counting of drugs taken every day), Mini Nutritional Assessment (MNA), Geriatric Depression Scale (GDS), Skeletal Muscle Index of sarcopenia (SMI), osteoporosis and functionality (Handgrip strength). RESULTS: According with the EFS, the 19.7% of subjects were classified as non frail, 66.4% as apparently vulnerable and 13.9% with severe frailty. The EFS scores were associated with cognition (MMSE: ß = 0.980; p < 0.01), functional independence (ADL: ß = -0.512; p < 0.00); (IADL: ß = -0.338; p < 0.01); use of medications (ß = 0.110; p < 0.01); nutrition (MNA: ß = -0.413; p < 0.01); mood (GDS: ß = -0.324; p < 0.01); functional performance (Handgrip: ß = -0.114, p < 0.01) (BI: ß = -0.037; p < 0.01), but not with number of comorbidities (ß = 0.108; p = 0.052). In osteoporotic patients versus not-osteoporotic patients the mean EFS score did not differ between groups (women: p = 0.365; men: p = 0.088), whereas in Sarcopenic versus not-Sarcopenic patients, there was a significant differences in women: p < 0.05. CONCLUSIONS: This study suggests that measuring frailty with EFS is helpful and performance tool for stratifying the state of fragility in a group of institutionalized elderly. As matter of facts the EFS has been shown to be associated with several geriatric conditions such independence, drugs assumption, mood, mental, functional and nutritional status.

Pharmacological Approaches for the Management of Persistent Pain in Older Adults: What Nurses Need to Know.

HOW TO OBTAIN CONTACT HOURS BY READING THIS ARTICLE INSTRUCTIONS 1.4 contact hours will be awarded by Villanova University College of Nursing upon successful completion of this activity. A contact hour is a unit of measurement that denotes 60 minutes of an organized learning activity. This is a learner-based activity. Villanova University College of Nursing does not require submission of your answers to the quiz. A contact hour certificate will be awarded once you register, pay the registration fee, and complete the evaluation form online at http://goo.gl/gMfXaf. To obtain contact hours you must: 1. Read the article, "Pharmacological Approaches for the Management of Persistent Pain in Older Adults: What Nurses Need to Know" found on pages 49-57, carefully noting any tables and other illustrative materials that are included to enhance your knowledge and understanding of the content. Be sure to keep track of the amount of time (number of minutes) you spend reading the article and completing the quiz. 2. Read and answer each question on the quiz. After completing all of the questions, compare your answers to those provided within this issue. If you have incorrect answers, return to the article for further study. 3. Go to the Villanova website listed above to register for contact hour credit. You will be asked to provide your name; contact information; and a VISA, MasterCard, or Discover card number for payment of the $20.00 fee. Once you complete the online evaluation, a certificate will be automatically generated. This activity is valid for continuing education credit until November 30, 2019. CONTACT HOURS This activity is co-provided by Villanova University College of Nursing and SLACK Incorporated. Villanova University College of Nursing is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. ACTIVITY OBJECTIVES 1. Describe age-related barriers to pain assessment and key aspects of the assessment process. 2. Identify benefits and risks associated with commonly prescribed analgesic medications for the treatment of later life pain. DISCLOSURE STATEMENT Neither the planners nor the authors have any conflicts of interest to disclose. The current article addresses pharmacological treatment issues regarding the management of persistent pain in later life, which is a worldwide problem associated with substantial disability. Recommendations from guidelines were reviewed and data are presented regarding the benefits and risks of commonly prescribed analgesic medications. The evidence base supports a stepwise approach with acetaminophen as first-line therapy for mild-to-moderate pain. Oral nonsteroidal anti-inflammatory drugs are not recommended for long-term use. In properly selected older patients, opioid drugs should be considered if pain is not adequately controlled. Careful surveillance to monitor for benefits and harms of therapy is critical, given that advancing age increases risk for adverse effects. Key aspects of the pain care process that nurses routinely engage in are covered, including conducting pain assessments prior to initiating therapy, addressing barriers to effective pain care, educating patients and family members about the importance of reducing pain, discussing treatment-related risks and benefits, and formulating strategies to monitor for treatment outcomes. Finally, a case is presented to illustrate issues that arise in the care of affected patients. [Journal of Gerontological Nursing, 42(12), 49-57.].

Effectiveness of a Short-Term Treatment of Oxygen-Ozone Therapy into Healing in a Posttraumatic Wound.

Introduction. A number of studies suggest that oxygen-ozone therapy may have a role in the treatment of chronic, nonhealing, or ischemic wounds for its disinfectant and antibacterial properties. Nonhealing wounds are a significant cause of morbidity. Here we present a case of subcutaneous oxygen-ozone therapy used to treat a nonhealing postoperative wound in a young man during a period of 5 weeks. Case Presentation. A 46-year-old man had a motorcycle accident and underwent amputation of the right tibia and fibula. At the discharge he came to our attention to start rehabilitation treatment. At that time the wound was ulcerated but it was afebrile with no signs of inflammation and negativity to blood tests. At 2 months from the trauma despite appropriate treatment and dressing, the wound was slowly improving and the patient complained of pain. For this reason in addition to standard dressing he underwent oxygen-ozone therapy. After 5 weeks of treatment the wound had healed. Conclusion. In patients with nonhealing wounds, oxygen-ozone therapy could be helpful in speeding the healing and reducing the pain thanks to its disinfectant property and by the increase of endogenous oxygen free radicals' scavenging properties. Compared to standard dressing and other treatments reported in the literature it showed a shorter time of action.

Long-term efficacy and safety of oxycodone-naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study.

BACKGROUND: Two-thirds of older people suffer from chronic pain and finding valid treatment options is essential. In this 1-yearlong investigation, we evaluated the efficacy and safety of prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 (mean 81.7) years. METHODS: In this open-label prospective study, patients with moderate-to-severe noncancer chronic pain were prescribed OXN-PR for 1 year. The primary endpoint was the proportion of patients who achieved ≥30% reduction in pain intensity after 52 weeks of treatment, without worsening bowel function. The scheduled visits were at baseline (T0), after 4 weeks (T4), and after 52 weeks (T52). RESULTS: Fifty patients completed the study. The primary endpoint was achieved in 78% of patients at T4 and 96% at T52 (P<0.0001). Pain intensity, measured on a 0-10 numerical rating scale, decreased from 6.0 at T0 to 2.8 at T4 and to 1.7 at T52 (P<0.0001). Mean daily dose of oxycodone increased from 10 to 14.4 mg (T4) and finally to 17.4 mg (T52). Bowel Function Index from 35.1 to 28.7 at T52. No changes were observed in cognitive functions (Mini-Mental State Examination evaluation), while daily functioning improved (Barthel Index from 53.1 to 61.0, P<0.0001). The Screener and Opioid Assessment for Patients with Pain-Revised score at 52 weeks was 2.6 (standard deviation 1.6), indicating a low risk of aberrant medication-related behavior. In general, OXN-PR was well tolerated. CONCLUSION: This study of the long-term treatment of chronic pain in a geriatric population with OXN-PR shows satisfying analgesic effects achieved with a stable low daily dose, coupled with a good safety profile and, in particular, with a reduction of constipation, often present during opioid therapy. Our findings support the indications of the American Geriatrics Society, suggesting the use of opioids to treat pain in older people not responsive to acetaminophen or nonsteroidal anti-inflammatory drugs.

Nutritional management in an elderly man with esophageal and gastric necrosis after caustic soda ingestion: a case report.

The ingestion of corrosive industrial chemical agents, such as caustic soda, that are mostly used for household cleaning, usually occurs accidentally or for suicidal purposes. Multiple protocols are based on documented success in preventing impending complications. In this study, we present a case of a 70-year-old man who swallowed caustic soda in a suicide attempt, causing a development of strong esophageal and gastric necrosis with subsequent gastrectomy and digiunostomy. Initially, the recommended nutritional approach was via percutaneous endoscopic jejunostomy by a polymer and high-caloric formula, with an elevated content of soluble fiber. After 5 months, the medical team removed the percutaneous endoscopic jejunostomy and the patient switched from enteral to oral nutrition. In this step, it was decided to introduce two oral, high-caloric supplements: an energy supplement in powder, based on maltodextrin, immediately soluble in foods or in hot/cold drinks and a high-energy and protein drink, enriched with arginine, vitamin C, zinc, and antioxidants. Oral administration (per os) was well tolerated by consuming homogenized food mixed in water. After 1 month, the patient was discharged from the hospital and was able to eat a regular meal.

Liraglutide and obesity in elderly: efficacy in fat loss and safety in order to prevent sarcopenia. A perspective case series study.

BACKGROUND: For the growing numbers of obese elderly with diabetes, the glucagon-like peptide-1 (GLP-1) receptor analogue (liraglutide) appears a safe way to promote and maintain substantial weight loss. Given this background, the aim of this study was to assess the effect of the liraglutide treatment, at doses up to 3.0 mg per day, on the body composition, focusing on sarcopenia, in overweight and obese elderly with type 2 diabetes mellitus (T2DM). METHODS: A perspective study was carried out in overweight and obese T2DM patients with HbA1c equal to 7.0 % (53 mmol/mol) ~10.0 % (86), under 3-month treatment (at least) of maximal dose of metformin at stable regime, and additional liraglutide at doses up to 3.0 mg per day. Body composition markers such as skeletal muscle index (SMI), android and gynoid fat mass, and arms and legs fat free mass, was measured by dual-energy X-ray densitometry (DXA) at baseline and after 24 weeks of liraglutide treatment. Glucose control was also carried out by glucose and HbA1c. RESULTS: Nine subjects (male/female 6/3, mean age 68.22 ± 3.86 years, BMI 32.34 ± 4.89 kg/m2) were evaluated. We noted a median decrease in BMI (-0.78 kg/m2), weight (-2000 g), fat mass (-1498 g) and android fat (-0.9 %), and a increase in SMI (+0.03 kg/m2) from baseline. Glycemic control also improved, with a median change HbA1c of -0.80 %. CONCLUSIONS: Twenty-four weeks of liraglutide treatment was associated with reductions in fat mass and android fat. In addition, in order to prevent sarcopenia, it preserved the muscular tropism.

Extremely low frequency electromagnetic fields stimulation modulates autoimmunity and immune responses: a possible immuno-modulatory therapeutic effect in neurodegenerative diseases.

Increasing evidence shows that extremely low frequency electromagnetic fields (ELF-EMFs) stimulation is able to exert a certain action on autoimmunity and immune cells. In the past, the efficacy of pulsed ELF-EMFs in alleviating the symptoms and the progression of multiple sclerosis has been supported through their action on neurotransmission and on the autoimmune mechanisms responsible for demyelination. Regarding the immune system, ELF-EMF exposure contributes to a general activation of macrophages, resulting in changes of autoimmunity and several immunological reactions, such as increased reactive oxygen species-formation, enhanced phagocytic activity and increased production of chemokines. Transcranial electromagnetic brain stimulation is a non-invasive novel technique used recently to treat different neurodegenerative disorders, in particular Alzheimer's disease. Despite its proven value, the mechanisms through which EMF brain-stimulation exerts its beneficial action on neuronal function remains unclear. Recent studies have shown that its beneficial effects may be due to a neuroprotective effect on oxidative cell damage. On the basis of in vitro and clinical studies on brain activity, modulation by ELF-EMFs could possibly counteract the aberrant pro-inflammatory responses present in neurodegenerative disorders reducing their severity and their onset. The objective of this review is to provide a systematic overview of the published literature on EMFs and outline the most promising effects of ELF-EMFs in developing treatments of neurodegenerative disorders. In this regard, we review data supporting the role of ELF-EMF in generating immune-modulatory responses, neuromodulation, and potential neuroprotective benefits. Nonetheless, we reckon that the underlying mechanisms of interaction between EMF and the immune system are still to be completely understood and need further studies at a molecular level.

Effectiveness of an Innovative Pulsed Electromagnetic Fields Stimulation in Healing of Untreatable Skin Ulcers in the Frail Elderly: Two Case Reports.

Introduction. Recalcitrant skin ulcers are a major burden in elderly patients. Specifically, chronic wounds result in significant morbidity and mortality and have a profound economic impact. Pulsed electromagnetic fields (PEMFs) have proved to be a promising therapy for wound healing. Here we describe the first reported case of an innovative PEMF therapy, Emysimmetric Bilateral Stimulation (EBS), used to successfully treat refractory skin ulcers in two elderly and fragile patients. Case Presentation. Two elderly patients developed multiple chronic skin ulcerations. Despite appropriate treatment, the ulcers showed little improvement and the risk of amputation was high. Both patients underwent daily EBS therapy and standard dressing. After few weeks of treatment, major improvements were observed and all ulcers had healed. Conclusion. In patients with refractory ulceration, EBS therapy may be of real benefit in terms of faster healing. This case supports the supportive role for PEMFs in the treatment of skin ulceration in diabetes and is suggestive of a potential benefit of EBS in this clinical condition.

An innovative intervention for the treatment of cognitive impairment-Emisymmetric bilateral stimulation improves cognitive functions in Alzheimer's disease and mild cognitive impairment: an open-label study.

BACKGROUND AND AIMS: In the last decade, the development of different methods of brain stimulation by electromagnetic fields (EMF) provides a promising therapeutic tool for subjects with impaired cognitive functions. Emisymmetric bilateral stimulation (EBS) is a novel and innovative EMF brain stimulation, whose working principle is to introduce very weak noise-like stimuli through EMF to trigger self-arrangements in the cortex of treated subjects, thereby improving cognitive faculties. The aim of this pilot study was to investigate in patients with cognitive impairment the effectiveness of EBS treatment with respect to global cognitive function, episodic memory, and executive functions. METHODS: Fourteen patients with cognitive decline (six with mild cognitive impairment and eight with Alzheimer's disease) underwent three EBS applications per week to both the cerebral cortex and auricular-specific sites for a total of 5 weeks. At baseline, after 2 weeks and 5 weeks, a neuropsychological assessment was performed through mini-mental state examination, free and cued selective reminding tests, and trail making test. As secondary outcomes, changes in behavior, functionality, and quality of life were also evaluated. RESULTS: After 5 weeks of standardized EBS therapy, significant improvements were observed in all neurocognitive assessments. Mini-mental state examination score significantly increased from baseline to end treatment (+3.19, P=0.002). Assessment of episodic memory showed an improvement both in immediate and delayed recalls (immediate recall =+7.57, P=0.003; delayed recall =+4.78, P<0.001). Executive functions significantly improved from baseline to end stimulation (trail making test A -53.35 seconds; P=0.001). Of note, behavioral disorders assessed through neuropsychiatric inventory significantly decreased (-28.78, P<0.001). The analysis concerning the Alzheimer's disease and mild cognitive impairment group confirmed a significant improvement of cognitive functions and behavior after EBS treatment. CONCLUSION: This pilot study has shown EBS to be a promising, effective, and safe tool to treat cognitive impairment, in addition to the drugs presently available. Further investigations and controlled clinical trials are warranted.

Is oxycodone/naloxone effective and safe in managing chronic pain of a fragile elderly patient with multiple skin ulcers of the lower limbs? A case report.

Skin ulcers are a common issue in the elderly, as physiological loss of skin elasticity, alterations in microcirculation, and concomitant chronic diseases typically occur in advanced age, thereby predisposing to these painful lesions. Wound-related pain is often associated with skin ulcers and negatively impacts both the patient's quality of life and, indirectly, wound healing. Pain management is an ongoing issue in the elderly, and remains underestimated and under-treated in this fragile population. Recent guidelines suggest the use of opioids as the frontline treatment of moderate and severe pain in nononcological pain in the elderly. However, due to the concerns of adverse reactions, drug interactions, and addiction, clinicians frequently hesitate to prescribe opioids. This case report describes an elderly diabetic patient with multiple ulcers of the lower limbs suffering wound-related pain. In our report, oxycodone/naloxone has proved to be an effective and safe drug, providing pain relief as well as increased compliance when redressing wounds and faster healing compared to that in similar patients. Our case provides anecdotal evidence, supported by other studies, to justify future, larger studies on chronic pain using this therapy.

A comorbidity prognostic effect on post-hospitalization outcome in a geriatric rehabilitation setting: the pivotal role of functionality, assessed by mediation model, and association with the Brass index.

BACKGROUND: Discharge planning is a critical feature of hospital's care in geriatric rehabilitation centers. The aim of this study was to evaluate the effects of comorbidity and functionality in identifying patients who are at risk of discharge problems. We also evaluate the association between Blaylock Risk Assessment Screening Score, BRASS index (BI), and post-hospitalization outcome (PHO). METHODS: Eighty patients (58 women and 22 men, with mean age equal to 83.28 ± 6.77 years) at geriatric rehabilitation division admission were screened with Geriatric Multidimensional Assessment (GMA). Then, BI and PHO were evaluated (mean follow-up time was 205.1 ± 95.8 days). By Structural Equation Model, we evaluated the existing causal relationships between comorbidity, functionality and PHO, elements of GMA, and the association between PHO and BI. RESULTS: Comorbidity acted on PHO through functionality with indirect effect only (+0.703, P = 0.019). So, the functionality assumes a pivotal role of the causal relationship comorbidity to PHO. BI is positively associated with PHO: correlation returned was equal to +0.313 (P = 0.019). CONCLUSIONS: The comorbidity has a role in getting worse PHO, but its effect is possible only through the mediation of functional status. The study also demonstrated the positive association between BI and PHO.

Efficacy and tolerability of low-dose oral prolonged-release oxycodone/naloxone for chronic nononcological pain in older patients.

PURPOSE: Chronic pain is highly prevalent in older adults. Increasing evidence indicates strong opioids as a valid option for chronic pain management in geriatrics. The aim of this study was to evaluate efficacy and safety of low-dose oral prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 years. METHODS: This open-label prospective study assessed older patients naïve to strong opioids presenting with moderate-to-severe chronic pain. Patients were prescribed OXN-PR at an initial dose of 10/5 mg/day for 28 days. In case of insufficient analgesia, the initial daily dose could be increased gradually. The primary efficacy measure was change in pain intensity from baseline, assessed by a ten-point Numeric Rating Scale (NRS) at day 28 (T28). Changes in cognitive state, daily functioning, quality of life, constipation, and other adverse events were assessed. RESULTS: Of 53 patients enrolled (mean 81.7±6.2 years [range 70-92 years]), 52 (98.1%) completed the 28-day observation. At T28, the primary end point (≥30% reduction in mean pain from baseline in the absence of bowel function deterioration) was achieved in 38 patients (71.7%). OXN-PR significantly relieved pain (NRS score -3.26; P<0.0001), as well as daily need for rescue paracetamol (from 86.8% at baseline to 40.4% at T28; P<0.001), and reduced impact of pain on daily activities (Brief Pain Inventory Short Form from 6.2±1.5 to 3.4±2.1; P<0.0001). OXN-PR was also associated with significant improvement in daily functioning (Barthel Index from 53.3±14.1 to 61.3±14.3; P<0.01). No changes were observed in cognitive status and bowel function. OXN-PR was well tolerated; only one patient (1.9%) prematurely withdrew from treatment, due to drowsiness. CONCLUSION: Findings from this open-label prospective study suggest that low-dose OXN-PR may be effective and well tolerated for treatment of moderate-to-severe chronic pain in older patients. Besides its effectiveness, these data indicate that low-dose OXN-PR may be considered a safe analgesic option in this fragile population and warrants further investigation in randomized controlled studies.