Clinical Pain Assessment Research Articles

Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial

BackgroundLow-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep.Methods/designOne hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group (LLLT, n = 60) or control group (CLLLT, n = 60). Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome (quality of life and sleep) will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the Tukey-Kramer post hoc test), and a paired t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤0.05).Trial registrationThe protocol for this study is registered with the Brazilian Registry of Clinical Trials – ReBEC (RBR-42gkzt)

89 Clinical Judgement and Pain Assessment in Critically Illchildren

Background and aimsDespite the various pain assessment tools available to date, pain assessment in critically ill children remains challenging for nurses. Clinical judgement of pain depends on different factors that...

192 Analgesia Modulates Cortical Response to Painful Procedures in Extremely Preterm Newborn Infants

IntroductionProper pain management in the neonatal intensive care unit (NICU) is essential. The clinical pain assessment depends on objective measurement of indirect behavioural and physiological pain indicators. Cortical pain processing...

Shoulder impingement syndrome: outcome of arthroscopic subacromial decompression.

To describe the outcome of cases with subacromial impingement syndrome managed with arthroscopic subacromial decompression. Quasi-experimental study. Section of Orthopaedics, Department of Surgery, The Aga Khan University Hospital, Karachi from April 2005 to March 2006. Thirty patients with impingement syndrome who underwent arthroscopic subacromial decompression after failed conservative treatment were included. The Constant and Murley shoulder scoring system was used for the clinical assessment of pain and function pre-operatively and 1, 6 and 24 weeks postoperatively. The postoperatively significant improvement was observed in the Constant and Murley scores in all the patients (by mean 40 points, p < 0.01), which was progressive over six months. Lower scores were noted in patients over 40 years of age, with advanced stage of impingement and partial tears of the rotator cuff. Arthroscopic subacromial decompression was effective in reducing pain and improving function in the studied patients with subacromial impingement syndrome.

Impact of PCA strategies on pain intensity and functional assessment measures in adults with sickle cell disease during hospitalized vaso‐occlusive episodes

Clinical trials of sickle cell disease (SCD) pain treatment usually observe only small decrements in pain intensity during the course of hospitalization. Sub-optimal analgesic management and inadequate pain assessment methods are possible explanations for these findings. In a search for better methods for assessing inpatient SCD pain in adults, we examined several pain intensity and interference measures in both arms of a randomized controlled trial comparing two different opioid PCA therapies. Based upon longitudinal analysis of pain episodes, we found that scores from daily average Visual Analogue Scales (VAS) and several other measures, especially the Brief Pain Inventory (BPI), were sensitive to change in daily improvements in pain intensity associated with resolution of vaso-occlusive pain. In this preliminary trial, the low demand, high basal infusion (LDHI) strategy demonstrated faster, larger improvements in various measures of pain than the high demand, low basal infusion (HDLI) strategy for opioid PCA dosing, however, verification in larger studies is required. The measures and statistical approaches used in this analysis may facilitate design, reduce sample size, and improve analyses of treatment response in future SCD clinical trials of vaso-occlusive episodes.

Prevalence of Neuropathic Features of Back Pain in Clinical Populations: Implications for the Diagnostic Triage Paradigm

SUMMARYContemporary clinical assessment of back pain is based on the diagnostic triage paradigm. The most common diagnostic classification is nonspecific back pain, considered to be of nociceptive etiology. A small proportion are diagnosed with radicular pain, of neuropathic origin. In this study we review the body of literature on the prevalence of neuropathic features of back pain, revealing that the point prevalence is 17% in primary care, 34% in mixed clinical settings and 53% in tertiary care. There is evidence that neuropathic features of back pain are not restricted to typical clinical radicular pain phenotypes and may be under-recognized, particularly in primary care. The consequence of this is that in the clinic, diagnostic triage may erroneously classify patients with nonspecific back pain or radicular pain. A promising alternative is the development of mechanism-based pain phenotyping in patients with back pain. Timely identification of contributory pain mechanisms may enable greater opportunity to select appropriate therapeutic targets and improve patient outcomes.

Complexities of pain assessment and management in hospitalised older people: A qualitative observation and interview study

BackgroundPain continues to be a common problem for older hospitalised patients, but little is known about how the complexities of actual clinical practice affect pain assessment and management in these patients. ObjectiveTo examine how pain was assessed and managed in older patients who were admitted to geriatric evaluation and management units. Design, setting and participantsA naturalistic observational research design was used involving observations of interactions between nurses and patients, and follow-up interviews with nurses. Three observation periods were conducted between midnight and midday, which commenced at 03:30, 07:30, and 10:30, and three observation periods were conducted between midday and midnight, which commenced at 15:30, 18:30, and 22:30. Between 12 and 13 observations were conducted for each observation period, each ranging from 2 to 3h. The study was undertaken in two units, each located in an Australian public teaching hospital. Participants included registered nurses employed in the units, and patients in their care. ResultsFour major themes were identified: communication among nurses and between older patients and nurses; strategies for pain management; environmental and organisational aspects of care; and complexities in the nature of pain. Nurses tended to use simple questioning with patients about the pain experienced. Despite the availability of ‘as required’ opioid medication for breakthrough or incident pain, nurses often preferred to wait to determine if pain was relieved following administration of fixed-dose paracetamol. Time of day impacted on how pain was managed due to availability of nursing staff. It was unit policy for doctors to reduce medications prescribed, which often extended to analgesics, and nurses were left to deal with patient tensions in addressing analgesic needs. Complexities were associated with the nature of pain experienced, in terms of perceived level of tolerable pain, the simultaneous presence of chronic and acute pain, location of pain, and differentiation of pain from discomfort. ConclusionsThis study demonstrated the intricacies associated with how analgesic needs are addressed in older patients, especially those with communication deficits, the complex nature of older patients’ painful experiences, and the precarious balance of attempting to treat pain effectively while avoiding adverse effects of analgesics.

A phase I/IIa study of the safety and efficacy of radium-223 chloride (Ra-223) with docetaxel (D) for castration-resistant prostate cancer (CRPC) patients with bone metastases.

TPS4694 Background: Ra-223is a first-in-class alpha-pharmaceutical that targets bone metastases (mets) with high energy alpha-particles of short range (&lt; 100 μm). In the ALSYMPCA trial, Ra-223 plus best standard of care (BSC) significantly improved OS vs placebo plus BSC in CRPC patients (pts) with bone mets (Parker et al. ECCO/ESMO 2011), and was shown to have an excellent safety profile. Since D is an approved chemotherapy with demonstrated survival benefit for pts progressing after castrating hormone therapy, it is logical to explore combining Ra-223 plus D in pts with CRPC and bone mets. This study is being conducted in the Prostate Cancer Clinical Trials Consortium with an aim to establish the safe dose of Ra-223 and D when used in combination in pts with bone mets with CRPC. Methods: This ongoing phase I/IIa trial (NCT01106352) is enrolling pts with bone mets from CRPC intended for treatment with D. D naïve pts are preferred, although up to 10 previous infusions of D are acceptable if D was well tolerated and the patient is in good condition and fulfills all eligibility criteria at study entry. Phase I dose-escalation study: minimum of 9 pts (max. 18 pts) will be included if no dose limiting toxicity (DLT) is observed. Dose escalation will follow a ‘3+3’ design, with no intra-patient dose escalation or overlapping of cohorts permitted. Ra-223 doses are 25 or 50 kBq/kg, with number of Ra-223 injections (inj) (2, 4, 5, or 10) and interval between inj (3 or 6 wks) varying by escalation schema; D doses are 60 or 75 mg/m2 q3wk. DLT will be assessed when 6 wks post-inj safety data are available after 1st Ra-223 +D inj. Phase IIa open-label expanded safety study: pts will be randomized 2:1 to the recommended dose of Ra‑223 to be used with D or to treatment with D alone (approx. 42 pts will be included). Primary endpoint is to assess safety of combining Ra-223 with D. Exploratory efficacy endpoints for the open-label expanded safety portion of the study include change in disease-related biomarkers, time to 1st radiological or clinical progression, CTC and pain assessment. Enrollment in dose-escalation portion of the study is complete; expanded safety cohort to begin enrolling in March 2012.

Comparative study of the effect of dexamethasone injection and consumption in lower third molar surgery

The aim of this study was to compare the effect of intramuscular (IM) injection and consumption of 8mg dexamethasone in patients after lower third molar (LTM) surgery. 20 healthy Thai patients, average age 20 years, with bilateral LTM removal were recruited for this study, a double blinded, paired sample clinical trial. The washout period was 1 month after the first operation. Clinical assessment of facial swelling, pain and maximum mouth opening were measured before and after operation for 7 days. No significant difference was found in facial swelling between IM injection and consumption of 8mg dexamethasone after LTM surgery (paired t test P>0.05). The visual analogue scale scores for pain assessment showed no significant difference between IM injection and consumption of dexamethasone (paired t test P>0.05). The results conclude that IM injection or consumption of dexamethasone after LTM surgery can be used to control facial swelling, pain and trismus.

A belief rule-based decision support system for clinical risk assessment of cardiac chest pain

This paper describes a prototype clinical decision support system (CDSS) for risk stratification of patients with cardiac chest pain. A newly developed belief rule-based inference methodology-RIMER was employed for developing the prototype. Based on the belief rule-based inference methodology, the prototype CDSS can deal with uncertainties in both clinical domain knowledge and clinical data. Moreover, the prototype can automatically update its knowledge base via a belief rule base (BRB) learning module which can adjust BRB through accumulated historical clinical cases. The domain specific knowledge used to construct the knowledge base of the prototype was learned from real patient data. We simulated a set of 1000 patients in cardiac chest pain to validate the prototype. The belief rule-based prototype CDSS has been found to perform extremely well. Firstly, the system can provide more reliable and informative diagnosis recommendations than manual diagnosis using traditional rules when there are clinical uncertainties. Secondly, the diagnostic performance of the system can be significantly improved after training the BRB through accumulated clinical cases.

Which clinical variables have the most significant correlation with quality of life evaluated by SF-36 survey in Croatian cohort of patient with ankylosing spondylitis and psoriatic arthritis?

The aim of our study was to assess clinical variables with the best correlation to quality of life (QOL) assessed by medical outcome survey Short-Form 36 (SF-36) in patients with spondyloarthritides, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA). We analyzed the cohort of 54 patients (22 patients with PsA and 32 patients with AS), who filled the Croatian version of SF-36. For each type of arthritis, patients were clinically evaluated using the extensive list of clinical variables categorized into subjective and objective group. For AS patients, subjective and objective variables (spinal mobility measurements, clinical assessment of spinal pain, patient assessments of disease activity and pain) correlated mainly with the physical functioning concept of SF-36. Patients assessments of fatigue correlated with the energy/fatigue subscale, whereas patient assessment of enthesial pain correlated with the pain subscale. Correlations between clinical variables and SF-36 concepts of PsA patients showed more diverse distribution than for AS. Objective variables (spinal mobility measurements, a 76-joint score, clinical assessment of spinal pain) correlated with concepts concerning physical health and pain. Several subjective patient assessments correlated with energy/fatigue, emotional well-being, pain and general health subscales. Both patient and physician assessment of PsA activity correlated with the role limitations due to emotional problems. Bath ankylosing spondylitis functional index (BASFI) had the strongest correlation with the physical functioning concept of SF-36 in both diseases. Our findings provide important information to help selecting the variables with strongest impact on QOL, for better planning the management strategies and achieving better rehabilitation results.

A randomised, double‐blinded, placebo‐controlled study on the efficacy of a unique extract of green‐lipped mussel (Perna canaliculus) in horses with chronic fetlock lameness attributed to osteoarthritis

Lyophilised products from green-lipped mussel (Perna canaliculus[LPPC]) are used to orally treat horses with osteoarthritis (OA). However, no randomised, controlled or double-blinded studies on the efficacy of this treatment in horses have been reported to date. To investigate the effects of a unique LPPC (Biolane)(1) in improving clinical signs of OA in the fetlock. Data were analysed from 26 horses with primary fetlock lameness in a controlled, randomised and double-blinded, multi-centre clinical trial. The study design was a partial crossover with a washout period and consisted of 19 horses treated with LPPC and 20 with a placebo. Horses were dosed orally with 25 mg/kg bwt/day LPPC or placebo for 56 days. Efficacy was evaluated by clinical assessment of lameness, passive flexion, pain, swelling and heat in the affected joint. Relationships between variables were analysed using an ordinal logistic model with random effects for horse and horse x treatment according to a modified intention-to-treat analysis. Clinical evaluation of horses with a fetlock lameness treated with LPPC showed a significant reduction in severity of lameness (P<0.001), improved response to the joint flexion test (P<0.001) and reduced joint pain (P = 0.014) when compared with horses treated with placebo. The LPPC significantly alleviated the severity of lameness and joint pain and improved response to joint flexion in horses with lameness attributable to OA in the fetlock.

Medial Ankle and Heel: Ultrasound Evaluation and Sonographic Appearances of Conditions Causing Symptoms

The complex anatomy of the medial ankle and hindfoot can make clinical assessment of medial ankle and heel pain challenging. Ultrasound is an accessible, relatively inexpensive modality, and modern high-resolution probes allow eloquent demonstration of the main structures that are implicated as potential causes of medial ankle pain. In this work we review highlights the clinically relevant anatomy and normal sonographic appearances of structures around the medial ankle and heel and discuss key techniques to allow optimal ultrasound assessment. The conditions that cause medial-sided ankle and heel symptoms are discussed with their characteristic sonographic appearances.

Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: A focused review

The Pain Research Group of the world health organization (WHO) Collaborating Centre for Symptom Evaluation in Cancer Care had developed the Brief Pain Inventory (BPI), a pain assessment tool for use with cancer patients. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). The objective of this review paper was to provide a detailed update of existing evidence on applicability of BPI in evaluation of patients with cancer pain. The BPI demonstrated good construct and concurrent validity. It was translated and validated into many languages – Brazilian, Chinese, Greek, Hindi, Italian, Japanese, Korean, Malay, Norwegian, Polish, Russian, Spanish, Taiwanese and Thai. The BPI was validated in patient populations such as bone metastases, breast cancer and postoperative cancer patients. The BPI can be used both as a quantitative or a qualitative measure for statistical analysis. The BPI was a powerful tool and, having demonstrated both reliability and validity across cultures and languages, was being adopted in many countries for clinical pain assessment, epidemiological studies, and in studies on the effectiveness of pain treatment. Future studies are warranted on its responsiveness and cross-cultural adaptation into other cancer pain syndromes and into other Indian languages.

Definition of remission and relapse in polymyalgia rheumatica: data from a literature search compared with a Delphi-based expert consensus

ObjectiveTo compare current definitions of remission and relapse in polymyalgia rheumatica (PMR) with items resulting from a Delphi-based expert consensus.MethodsRelevant studies including definitions of PMR remission and relapse were identified...

Post-traumatic stress disorder moderates the relation between documented childhood victimization and pain 30 years later

Cross-sectional designs and self-reports of maltreatment characterize nearly all the literature on childhood abuse or neglect and pain in adulthood, limiting potential for causal inference. The current study describes a prospective follow up of a large cohort of individuals with court-documented early childhood abuse or neglect (n=458) and a demographically matched control sample (n=349) into middle adulthood (mean age 41), nearly 30years later, comparing the groups for risk of adult pain complaints. We examine whether Post-Traumatic Stress Disorder (PTSD) mediates or moderates risk of pain. Assessed prospectively across multiple pain measures, physically and sexually abused and neglected individuals generally showed a significant (p<.05) but notably small (η2=.01) increased risk of pain symptoms in middle adulthood. Although PTSD was associated with both childhood victimization (p<.01) and risk of middle adulthood pain (p<.001), it did not appear to mediate the relationship between victimization and pain. However, across all pain outcomes other than medically unexplained pain, PTSD robustly interacted with documented childhood victimization to predict adult pain risk: Individuals with both childhood abuse/neglect and PTSD were at significantly increased risk (p<.001, η2 generally=.05−.06) of pain. After accounting for the combined effect of the two factors, neither childhood victimization nor PTSD alone predicted pain risk. Findings support a view that clinical pain assessments should focus on PTSD rather than make broad inquiries into past history of childhood abuse or neglect.

Mildly negative social encounters reduce physical pain sensitivity

While previous research has demonstrated a reduction in physical pain sensitivity in response to social exclusion, the manipulations employed have arguably been far removed from typical daily experience. The purpose of this study was to investigate the effects of relatively ordinary social encounters on the perception of pain. Healthy participants rated the intensity and unpleasantness of painful stimuli before and after engaging in a structured interaction with a confederate who was instructed to either be warm and friendly or indifferent. A control group was asked to perform a similar structured activity, but alone. Consistent with predictions, participants who experienced the mildly negative social exchange reported lower pain intensity and unpleasantness after the encounter relative to baseline, whereas those exposed to the positive social exchange did not evidence any change in pain ratings. These results were not mediated by changes in mood or perceived connectedness. If mildly negative social encounters can provoke an analgesic effect, it is possible that social hypoalgesia may be considerably more commonplace than previously realized. Discussion focuses on the role of stress-induced hypoalgesia, and the implications of the results for clinical assessments of pain.

Timely Troponins Avoid Admissions: Clinical Assessment of Undifferentiated Chest Pain

Background Undifferentiated chest pain is a common presentation to acute medicine units. Targeted appropriately timed troponin analysis may reduce unnecessary admissions and relieve bed shortages. We investigated how reliably cardiac chest pain was identified clinically, whether patients had appropriately timed cardiac enzyme analysis, and implications upon rates of admission. Method A prospective data collection was completed on 100 consecutive patients admitted with undifferentiated chest pain to an acute receiving unit over 41 days. We excluded patients with acute coronary syndrome or myocardial infarction already confirmed or excluded. Troponin results were retrospectively documented. Results Of 100 patients admitted, 67 were thought to have cardiac type chest pain as their only or significant differential diagnosis, and 10 were subsequently confirmed as ACS or MI. Not all patients with cardiac type chest pain were assessed in accordance with SIGN guidelines. 38 patients were admitted overnight solely to await the result of troponin analysis, with a total of 411.5 hours spent waiting at an estimated cost of over £7400. Conclusion This study supports the extension of hours of troponin analysis or instant point of care (bedside) cardiac enzyme testing as a cost effective measure, warranting further examination in terms of laboratory service provision.

Percutaneous kyphoplasty and pedicle screw fixation for the management of thoraco-lumbar burst fractures

The study design includes prospective evaluation of percutaneous osteosynthesis associated with cement kyphoplasty on 18 patients. The objective of the study is to assess the efficacy of a percutaneous method of treating burst vertebral fractures in patients without neurological deficits. Even if burst fractures are frequent, no therapeutic agreement is available at the moment. We report in this study the results at 2 years with a percutaneous approach for the treatment of burst fractures. 18 patients were included in this study. All the patients had burst vertebral fractures classified type A3 on the Magerl scale, between levels T9 and L2. The patients' mean age was 53 years (range 22-78 years) and the neurological examination was normal. A percutaneous approach was systematically used and a kyphoplasty was performed via the transpedicular pathway associated with percutaneous short-segment pedicle screw osteosynthesis. The patients' follow-up included CT scan analysis, measurement of vertebral height recovery and local kyphosis, and clinical pain assessments. With this surgical approach, the mean vertebral height was improved by 25% and a mean improvement of 11.28 degrees in the local kyphotic angle was obtained. 3 months after the operation, none of the patients were taking class II analgesics. The mean duration of their hospital stay was 4.5 days (range 3-7 days) and the mean follow-up period was 26 months (range 17-30 months). No significant changes in the results obtained were observed at the end of the follow-up period. Minimally invasive methods of treating burst vertebral fractures can be performed via the percutaneous pathway. This approach gives similar vertebral height recovery and kyphosis correction rates to those obtained with open surgery. It provides a short hospital stay, however, and might therefore constitute a useful alternative to open surgical methods.

Assessment of Cancer-Related Neuropathy and Neuropathic Pain

Cancer-related neuropathic pain syndromes are common and serious complications of a patient's primary malignancy or its treatment, whether by surgery, radiation, or chemotherapy. They may compromise the patient's quality of life as well as their ability to receive effective treatment. In many patients, there may be more than one coexistent neuropathic pain syndrome, posing a diagnostic dilemma that, if unresolved, may result in the institution of therapies that are of limited scope or not targeted at the primary underlying pathophysiology. There is no single adequate diagnostic method that has been established to reliably diagnose or follow patients with cancer-related neuropathic pain syndromes. Clinical assessment of cancer-related neuropathic pain poses some important challenges diagnostically as well as in defining a clear and reliable endpoint assessment in controlled clinical trials. Many different approaches have been applied to the development of assessment or diagnostic tools. Careful review of these methods has been helpful in developing a clearer vision for the future design and refinement of more reliable tools, and more importantly, validation of the clinical utility as well as the reliability of such tools when employed as endpoints in clinical trials focused on prevention, mitigation, or treatment of cancer neuropathic pain.