Mean Pain Reduction Research Articles

The effect of leek (Allium iranicum (Wendelbo)) leaves extract cream on hemorrhoid patients: A double blind randomized controlled clinical trial

IntroductionConsidering the known pharmacological effects of Allium iranicum and the use of this herb in traditional Persian medicine (TPM) as an antihemorrhoid agent, we evaluated the efficacy of A. iranicum leaf extract cream for management of hemorrhoids in a double blind randomized placebo control trial. MethodsEighty patients with symptomatic hemorrhoids were randomly allocated to three groups to receive topical leek cream or placebo cream or routine cream for the management of hemorrhoids (antihemorrhoid) for a period of 3 weeks. Bleeding severity (primary), pain, defecation discomfort, anal itching severity, and overall subjective improvement (secondary) were assessed as outcomes of this study. ResultsA significant reduction was observed in the bleeding severity, anal pain, defecation discomfort and anal itching of all patients. The leek cream group had significantly less bleeding severity than standard antihemorrhoid and placebo groups at the end of the study (0.26±0.75, 0.83±1.09, 0.35±0.93, respectively P=0.04). The number of patients with more than 50% subjective improvement was also significantly more in the leek cream group compared to other groups (12, 5, 6, respectively P=0.04). The mean reductions in pain, defecation discomfort and anal itching showed no significant difference between the three groups (P=0.07, 0.39, 0.33, respectively). ConclusionThe current study showed significantly better outcomes for the leek group compared to the standard antihemorrhoid and placebo groups for bleeding severity and overall subjective improvement. However, there was no difference among topical use of leek, routine antihemorrhoid and placebo creams symptomatic relief of pain, defecation discomfort and itching. This trial was registered by Iranian Registry of Clinical Trials with the code: IRCT2014010816143N1 and also registered in ClinicalTrials.gov with identifier: NCT02301052.

Exposure-response modeling of average daily pain score, and dizziness and somnolence, for mirogabalin (DS-5565) in patients with diabetic peripheral neuropathic pain

Mirogabalin (DS-5565) is an α2δ-1 ligand being developed for pain associated with diabetic peripheral neuropathy, fibromyalgia, and postherpetic neuralgia. Nonlinear mixed-effects analyses were performed on average daily pain and on the incidence of the adverse events dizziness and somnolence. These models were used to predict the dose of mirogabalin equivalent to pregabalin and the probability of meaningful reduction in pain compared with placebo and pregabalin. In addition, regimen effects were evaluated for reductions of adverse events. Mirogabalin was estimated to be 17-fold more potent than pregabalin. The effectiveness of 150 mg pregabalin, dosed twice daily, attenuated by week 5. Therefore, the estimated mechanism-based equivalent dose (ED) of 17.7 mg mirogabalin was higher than that predicted to achieve comparable pain reduction. If attenuation of the pregabalin effect is real, mirogabalin doses lower than the ED could yield comparable pain reduction, albeit with less differentiation in pain from placebo. The incidence rate of dizziness and somnolence decreased over time. Twice-daily dosing of mirogabalin was predicted to yield a lower incidence rate of dizziness than once-daily dosing; thus, titration of dosages should reduce adverse event rates. These model results were used to influence phase 3 dosing selection.

Altering Knee Abduction Angular Impulse Using Wedged Insoles for Treatment of Patellofemoral Pain in Runners: A Six-Week Randomized Controlled Trial.

ObjectiveDetermine if a change in internal knee abduction angular impulse (KAAI) is related to pain reduction for runners with patellofemoral pain (PFP) by comparing lateral and medial wedge insole interventions, and increased KAAI and decreased KAAI groups.DesignRandomized controlled clinical trial (ClinicalTrials.gov ID# NCT01332110).SettingBiomechanics laboratory and community.PatientsThirty-six runners with physician-diagnosed PFP enrolled in the trial, and 27 were analyzed.InterventionsRunners with PFP were randomly assigned to either an experimental 3 mm lateral wedge or control 6 mm medial wedge group. Participants completed a biomechanical gait analysis to quantify KAAIs with their assigned insole, and then used their assigned insole for six-weeks during their regular runs. Usual pain during running was measured at baseline and at six-week follow-up using a visual analog scale. Statistical tests were performed to identify differences between wedge types, differences between biomechanical response types (i.e. increase or decrease KAAI), as well as predictors of pain reduction.Main Outcome MeasuresPercent change in KAAI relative to neutral, and % change in pain over six weeks.ResultsClinically meaningful reductions in pain (>33%) were measured for both footwear groups; however, no significant differences between footwear groups were found (p = 0.697). When participants were regrouped based on KAAI change (i.e., increase or decrease), again, no significant differences in pain reduction were noted (p = 0.146). Interestingly, when evaluating absolute change in KAAI, a significant relationship between absolute % change in KAAI and % pain reduction was observed (R 2 = 0.21; p = 0.030), after adjusting for baseline pain levels.ConclusionThe greater the absolute % change in KAAI during running, the greater the % reduction in pain over six weeks, regardless of wedge type, and whether KAAIs increased or decreased. Lateral and medial wedge insoles were similar in effectiveness for treatment of PFP.Clinical RelevanceAltering KAAI should be a focus of future PFP research. Lateral wedges should be studied further as an alternative therapy to medial wedges for management of PFP.Trial RegistrationClinicalTrials.gov NCT01332110

Does adding cognitive-behavioural physiotherapy to exercise improve outcome in patients with chronic neck pain? A randomised controlled trial

ObjectivesTo determine whether adding a physiotherapist-led cognitive-behavioural intervention to an exercise programme improved outcome in patients with chronic neck pain (CNP). DesignMulticentre randomised controlled trial. SettingFour outpatient physiotherapy departments. ParticipantsFifty-seven patients with CNP. Follow-up data were provided by 39 participants [57% of the progressive neck exercise programme (PNEP) group and 79% of the interactive behavioural modification therapy (IBMT) group]. InterventionsTwenty-eight subjects were randomised to the PNEP group and 29 subjects were randomised to the IBMT group. IBMT is underpinned by cognitive-behavioural principles, and aims to modify cognitive risk factors through interactive educational sessions, graded exercise and progressive goal setting. Main outcome measuresThe main outcome measure was disability, measured by the Northwick Park Questionnaire (NPQ). Secondary outcomes were the Numeric Pain Rating Scale (NPRS), Pain Catastrophising Scale, Tampa Scale for Kinesiophobia (TSK), Chronic Pain Self-efficacy Scale (CPSS) and the Pain Vigilance and Awareness Questionnaire. ResultsNo significant between-group differences in disability were observed (mean NPQ change: PNEP=−7.2, IBMT=−10.2). However, larger increases in functional self-efficacy (mean CPSS change: PNEP=1.0, IBMT=3.2) and greater reductions in pain intensity (mean NPRS change: PNEP=−1.0, IBMT=−2.2; P<0.05) and pain-related fear (mean TSK change: PNEP=0.2, IBMT=−4.7, P<0.05) were observed with IBMT. Additionally, a significantly greater proportion of participants made clinically meaningful reductions in pain (25% vs 55%, P<0.05) and disability (25% vs 59%, P<0.05) with IBMT. ConclusionsThe primary outcome did not support the use of cognitive-behavioural physiotherapy in all patients with CNP. However, superior outcomes were observed for several secondary measures, and IBMT may offer additional benefit in some patients. Clinical Trial Registration NumberISRCTN27611394.

Clinically meaningful reduction in pain severity in children treated by paramedics: a retrospective cohort study

IntroductionPediatric pain is a common presenting symptom in the prehospital setting; however, there is a lack of data identifying factors associated with effective pain management in this population. We sought to identify the factors associated with clinically meaningful pain reduction in children. MethodsAn analysis of electronic patient care records of all patients younger than 15 years presenting with pain to the emergency medical service of Victoria, Australia, over a 4-year period (2008-2011). Data were analyzed using descriptive statistics and multivariate regression to assess predictors of clinically meaningful pain reduction. Clinically meaningful pain reduction was defined as a reduction of 2 or more points on an 11-point scale. ResultsA total of 92378 children were transported, of whom 15016 (16.3%) met the inclusion criteria. The median age was 11 (interquartile range, 9-13) years, and 59.2% were male. Patients older than 9 years were less likely (adjusted odds ratio [AOR], 0.5; 95% confidence interval [CI], 0.4-0.6) and boys were more likely (adjusted odds ratio, 1.1; 95% CI, 1.0-1.3) to have a clinically meaningful reduction in pain. Patients with pain classified as musculoskeletal were more likely to achieve a reduction in pain score of 2 or more when compared with pain due to other medical causes (AOR, 1.7; 95% CI, 1.5-1.9). ConclusionsFactors other than the type of analgesia are important determinants of prehospital pain relief and are likely to impact on clinical care and research. Clinical audit and research projects should stratify patients according to patient as well as management factors to maximize service improvement.

Intravenous Sodium Valproate for Acute Pediatric Headache

BackgroundHeadaches are common in the pediatric population, and increase in prevalence with age. The abortive medications currently used have a number of potential side effects. Sodium valproate (VPA) has been shown to be effective for acute treatment in the adult population, but no data exist in the pediatric population. ObjectiveThe objective of this study was to evaluate the effectiveness of VPA for acute pediatric headache in the emergency department. MethodsThis was a retrospective case series of all patients <19 years of age treated in the pediatric emergency department (PED) at two tertiary care pediatric hospitals and with a final diagnosis of migraine or headache who received parenteral VPA. Data collected included patient demographics, pain reduction, length of stay, and final disposition. ResultsFrom July 2010 to February 2014, there were 16 patients who received VPA for acute headache in the PED; 4 were excluded. Eighty-three percent were discharged home. Mean length of stay in the PED before VPA was 395 min, and 120 min after VPA administration. Patients achieved a 17% mean pain score reduction before VPA and approximately an additional 40% mean pain reduction after VPA infusion. ConclusionsVPA appears to be an effective agent for acute pediatric headache in this small series. Patients responded well to VPA in a relatively short amount of time. Further studies are needed to evaluate its effectiveness in combination with other first-line medications or as a single agent.

Spinal and Nucleus Caudalis Dorsal Root Entry Zone Lesioning for Chronic Pain: Efficacy and Outcomes

The role for nucleus caudalis (NC) and spinal dorsal root entry zone (DREZ) lesioning in the management of chronic pain emanating from increased electrical activity in the dorsal horn of the spinal cord and brainstem remains largely uncharted. All patients who underwent NC and spinal DREZ lesioning by a single surgeon were identified and follow-up was obtained by telephone questionnaires. Patient demographics, surgical details, outcomes, and complications were critically reviewed for all patients identified. Of 83 patients identified, 53 (63.9%) were male. Indications for NC DREZ lesioning included trigeminal neuropathic pain (6), trigeminal deafferentation pain (3), glossopharyngeal or occipital neuralgia (3), post-herpetic neuralgia (3), and trauma (1); for spinal DREZ lesioning, indications included brachial plexus avulsion (20), post-herpetic neuralgia (19), spinal cord injury (11), phantom limb pain (8), pelvic pain (5), and complex regional pain syndrome (4). Pain relief was most significant among patients with trigeminal pain, traumatic brachial plexus avulsion injuries, spinal cord injury, and traumatic phantom limb pain. Mean pain reduction averaged 58.3% at a mean follow-up of 8.3 years. Complications included 3 cases of paresis, 3 cases of neuropathy/radiculopathy, 2 cases of ataxia, 3 general medical conditions (colitis, 2; atelectasis, 1), and 2 cases of persistent incisional site pain. Pain relief lasted an average of 4.3 years. Spinal and NC DREZ lesioning can provide effective relief in well-selected patients with intractable chronic pain conditions arising from trigeminal pain, spinal cord injury, brachial plexus avulsions, post-herpetic neuralgia, and phantom limb pain.

Oxygen reduces tourniquet-associated pain: a double-blind, randomized, controlled trial for application in hand surgery.

Why do limb tourniquets cause pain? If ischemia is the mechanism, can supplemental oxygen reduce pain? The Reducing Tourniquet Associated Pain study investigated whether this simple treatment could extend tourniquet tolerance time to facilitate hand surgery under local or regional anesthesia. The Reducing Tourniquet Associated Pain study was a double-blind, randomized, controlled trial of healthy volunteers. Participants received either 50% inhaled oxygen or air placebo via a face mask for 3 minutes before and up to 30 minutes after upper arm tourniquet inflation to 250 mmHg. Pain scores were recorded at 2-minute intervals using a validated 100-mm visual analogue scale. The primary outcomes were (1) difference in visual analogue scale score and (2) difference in time taken to reach visual analogue score of 40 mm or more in oxygen and air groups. Fifty participants enrolled and, after exclusion criteria were applied, 46 were analyzed (oxygen, n = 23; air, n = 23). Oxygen supplementation was associated with a 29 percent mean reduction in pain on visual analogue scoring compared with air placebo over the entire period of inhalation (p = 0.027). Oxygen also extended the time to visual analogue scale score of 40 mm or more by a mean of 6½ minutes compared with air placebo (p = 0.008). Oxygen is a readily available, low-risk, low-cost treatment that significantly reduced tourniquet-associated pain in this study and significantly increased the time taken to reach visual analogue scale score of 40 or more. The authors recommend oxygen to facilitate hand surgery under a tourniquet and when a regional block fails to control tourniquet pain.

Could nerve growth factor inhibitors have a place in the treatment of knee osteoarthritis?: Impact of joint destruction and means of administration ossn the value of Tanezumabs

Could nerve growth factor inhibitors have a place in the treatment of knee osteoarthritis?: Impact of joint destruction and means of administration ossn the value of Tanezumabs

Cervical Transforaminal Epidural Steroid Injections: Diagnostic and Therapeutic Value.

Cervical transforaminal epidural steroid injections (CTFESIs) may help decrease pain and restore function in patients with cervical radiculopathy. Evidence of the injections' effectiveness, however, remains controversial, and multiple case reports have identified potential complications. Such reports have led to diminished interest in including the procedure in patient care algorithms. Our retrospective analysis aims to evaluate the CTFESI-associated pain relief and possible decreased need for spine surgery, along with its potential predictive role in determining cervical surgical outcomes. Finally, our study intends to estimate associated complications. A pain management database registry was used to identify patients who were referred by spine surgeons for diagnostic CTFESIs in preparation for possible surgery between January 2001 and December 2009. Outcomes were defined as the incidence of cervical surgery after diagnostic injection and the associated pain relief. A Poisson distribution was used to obtain a 95% confidence interval for the incidence of complications. Sixty-four patients met the inclusion and exclusion criteria. After diagnostic CTFESIs, 45 (70.3%) of the observed 64 patients did not require cervical spine surgery whereas 19 (29.7%) still did. The mean pain reduction was 4.4 units on the numeric rating scale, with no observed complications. This retrospective analysis further demonstrates the safety, diagnostic value, and possible therapeutic role of CTFESIs. A larger, controlled, randomized study is needed to assess definitively the procedure's efficacy and safety.

Clinical efficacy of intra-articular injections in knee osteoarthritis: a prospective randomized study comparing hyaluronic acid and betamethasone.

BackgroundOsteoarthritis (OA) is the most common joint disease and leading cause of disability. Intra-articular (IA) administration of hyaluronic acid (HA) or corticosteroids (CS) have been previously studied, though using insufficient number of patients or short follow-up periods.ObjectiveWe evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months.MethodsWe used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM). The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale). Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months.ResultsA total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1) compared to 8.2% (95% CI: 5.2–11.1) in BM (P<0.0001). Function improvement was higher in HA through every visit, and mean improvement at 12 months was 47.5% (95% CI: 45.6–49.3) in HA patients vs 13.2% (95% CI: 11.4–14.9) in the BM group (P<0.0001). All patients from both groups achieved the Minimal Clinically Important Improvement (MCII) for both pain and function up to 6 months. At 9 months and 12 months, the MCII figures were higher in HA group with ≥80% compared to ≤10% in BM group (P<0.0001). Adverse reactions were rare and related to the administration procedure.ConclusionBoth treatments effectively controlled OA symptoms. BM showed higher short-term effectiveness, while HA showed better long-term effectiveness, maintaining clinical efficacy in a large number of patients 1 year after administration.

Tapentadol Prolonged Release as Used in Clinical Practice in Patients with Severe Chronic Tumor Pain

Objective: This subgroup analysis of a non-interventional study that included general practitioners and internists, assessed efficacy and safety of tapentadol prolonged release (Palexia® retard) as used in routine clinical practice in Germany for the treatment of severe chronic tumor pain. Study design: Data of all patients in the study cohort who were exclusively diagnosed with ‘tumor pain’ (n=143) were included in this analysis. Data collection during the 3-month observation period included previous analgesic and concomitant treatment, tapentadol PR dosage, pain intensity, sleep and quality of life parameters and tolerability of tapentadol PR. Results: A total of 96.5% of all patients with tumor pain had already received analgesic long-term treatment before initiation of tapentadol PR therapy, 49.0% of those had received strong opioids. Switching to tapentadol PR resulted in a mean pain reduction of 3.8 points from 7.1 ± 1.4 at baseline to 3.3 ± 1.9 at end of observation (NRS-11, 11-point pain scale; descriptive p value 50%, and 89.9% of the patients attained either their desired pain reduction and/or an additional individual treatment goal; both goals had been predefined at start of tapentadol PR treatment. This was accompanied by a significant decrease in pain-related impairments of daily activities and an improvement in quality of life (descriptive p value<0.001) with an overall good tolerability of tapentadol PR. Treatment with tapentadol PR was assessed positively by physicians and patients. Conclusions: In this routine clinical practice non-interventional study, treatment with tapentadol PR resulted in effective and well-tolerated relief of severe tumor pain and improvement of pain-related impairments of daily activities and quality of life. Tapentadol PR, an innovative effective analgesic, may thus provide an alternative treatment option in the management of tumor pain.

Immune activation and autoimmunity in chronic pain conditions and response to immunoglobulin G.

Immune activation and autoimmunity in chronic pain conditions and response to immunoglobulin G.

Ultrasound-Guided Stellate Ganglion Blocks Combined with Pharmacological and Occupational Therapy in Complex Regional Pain Syndrome (CRPS): A Pilot Case SeriesAd Interim

This preliminary and retrospective pilot case series examines a treatment concept consisting of ultrasound-guided stellate ganglion blocks (SGBs) combined with pharmacological and occupational therapy in patients with complex regional pain syndrome (CRPS) of the hand. Efficacy of combined treatment concepts and safety of ultrasound-guided SGB have not been sufficiently investigated yet. A total number of 156 blocks were evaluated in 16 patients with CRPS in a retrospective analysis. All patients received pharmacotherapy and a standard regimen of occupational therapy offered simultaneously to the SGBs. Changes in both spontaneous and evoked pain levels were assessed by numerical pain rating score before and after the last blockade of a series. Side effects were documented. The overall mean pain reduction was 63.2% regarding spontaneous and 45.3% regarding evoked pain. Mild complications, such as hoarseness or dysphagia, occurred in 13.5% of the blocks (21 SGBs). Serious complications, such as plexus paresis or accidental puncture of vessels or other structures, did not occur. Time between symptom onset and start of treatment did not affect the extent of pain reduction. The combination of ultrasound-guided SGB and simultaneous pharmacological and occupational therapy showed encouraging treatment results under conditions of this pilot case series. Assessment of efficacy of this combined treatment concept and safety of ultrasound-guided SGB require further prospective clinical studies with larger number of participants.

Effect of low-level laser therapy on pain and swelling in women with breast cancer-related lymphedema: a systematic review and meta-analysis.

This study aims to examine literature on effectiveness of low-level laser therapy (LLLT) in reducing limb volume and pain in adults with breast cancer-related lymphedema (BCRL). PubMed, PEDro, CINAHL, and Cochrane databases were searched using (lymphedema OR edema OR swelling) AND (breast cancer OR mastectomy) AND (laser OR low-level laser therapy OR LLLT OR cold laser). Intervention studies or meta-analyses reporting LLLT for BCRL were included in the search. Pooled effect sizes (ES) and 95 % confidence intervals (CI) were calculated for volume and pain. No limitations were placed on length of follow-up, publication year, or language. Final search was conducted on October 16, 2014. Nine studies met criteria for inclusion. Within-group pooled ES for volume (six studies) was -0.52 (-0.78, -0.25), representing a 75.7-ml reduction in limb volume after LLLT. Between-group pooled ES for volume (four studies) was -0.62 (-0.97, -0.28), representing a 90.9-ml greater reduction in volume with treatment including LLLT versus not including LLLT. Within-group pooled ES for pain reduction (three studies) was -0.62 (-1.06, -0.19), pain reduction of 13.5 mm (0-100 mm VAS). Between-group pooled ES for pain reduction (two studies) was non-significant at -1.21 (-4.51, 2.10). Moderate-strength evidence supports LLLT in the management of BCRL, with clinically relevant within-group reductions in volume and pain immediately after conclusion of LLLT treatments. Greater reductions in volume were found with the use of LLLT than in treatments without it. LLLT confers clinically meaningful reductions in arm volume and pain in women with BCRL.

Non-pharmacological interventions for chronic pain in people with spinal cord injury.

Chronic pain is frequent in persons living with spinal cord injury (SCI). Conventionally, the pain is treated pharmacologically, yet long-term pain medication is often refractory and associated with side effects. Non-pharmacological interventions are frequently advocated, although the benefit and harm profiles of these treatments are not well established, in part because of methodological weaknesses of available studies. To critically appraise and synthesise available research evidence on the effects of non-pharmacological interventions for the treatment of chronic neuropathic and nociceptive pain in people living with SCI. The search was run on the 1st March 2011. We searched the Cochrane Injuries Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), four other databases and clinical trials registers. In addition, we manually searched the proceedings of three major scientific conferences on SCI. We updated this search in November 2014 but these results have not yet been incorporated. Randomised controlled trials of any intervention not involving intake of medication or other active substances to treat chronic pain in people with SCI. Two review authors independently extracted data and assessed risk of bias in the included studies. The primary outcome was any measure of pain intensity or pain relief. Secondary outcomes included adverse events, anxiety, depression and quality of life. When possible, meta-analyses were performed to calculate standardised mean differences for each type of intervention. We identified 16 trials involving a total of 616 participants. Eight different types of interventions were studied. Eight trials investigated the effects of electrical brain stimulation (transcranial direct current stimulation (tDCS) and cranial electrotherapy stimulation (CES); five trials) or repetitive transcranial magnetic stimulation (rTMS; three trials). Interventions in the remaining studies included exercise programmes (three trials); acupuncture (two trials); self-hypnosis (one trial); transcutaneous electrical nerve stimulation (TENS) (one trial); and a cognitive behavioural programme (one trial). None of the included trials were considered to have low overall risk of bias. Twelve studies had high overall risk of bias, and in four studies risk of bias was unclear. The overall quality of the included studies was weak. Their validity was impaired by methodological weaknesses such as inappropriate choice of control groups. An additional search in November 2014 identified more recent studies that will be included in an update of this review.For tDCS the pooled mean difference between intervention and control groups in pain scores on an 11-point visual analogue scale (VAS) (0-10) was a reduction of -1.90 units (95% confidence interval (CI) -3.48 to -0.33; P value 0.02) in the short term and of -1.87 (95% CI -3.30 to -0.45; P value 0.01) in the mid term. Exercise programmes led to mean reductions in chronic shoulder pain of -1.9 score points for the Short Form (SF)-36 item for pain experience (95% CI -3.4 to -0.4; P value 0.01) and -2.8 pain VAS units (95% CI -3.77 to -1.83; P value < 0.00001); this represented the largest observed treatment effects in the included studies. Trials using rTMS, CES, acupuncture, self-hypnosis, TENS or a cognitive behavioural programme provided no evidence that these interventions reduce chronic pain. Ten trials examined study endpoints other than pain, including anxiety, depression and quality of life, but available data were too scarce for firm conclusions to be drawn. In four trials no side effects were reported with study interventions. Five trials reported transient mild side effects. Overall, a paucity of evidence was found on any serious or long-lasting side effects of the interventions. Evidence is insufficient to suggest that non-pharmacological treatments are effective in reducing chronic pain in people living with SCI. The benefits and harms of commonly used non-pharmacological pain treatments should be investigated in randomised controlled trials with adequate sample size and study methodology.

Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial.

The aim of the study was to evaluate cryoablation (CA) under ultrasound guidance in the office setting with liquid nitrogen system for patients with fibroadenoma (FA). For this prospective multicenter trial, an office-based cryosurgical system was used to treat histological confirmed benign FA with a maximum dimension of 3 cm. Sixty CA procedures were performed under ultrasound guidance. A freeze-thaw-freeze treatment cycle was performed according to the size of the FA. During the CA procedure continuous ultrasound monitoring was performed, verifying engulfment of the FA. Patients attended four follow-up visits at 1 week, 3, 6 months and 1 year and underwent ultrasound, physical examination and photography. Data were collected and analyzed in 60 cases. 59 of 60 FA (98 %) were fully engulfed by the ice ball. No serious adverse events occurred related to the IceSense3 system. At the 1-year follow-up, the FAs were gone in 93% of the cases. Prior to CA procedure, 76% of the FAs were palpable. Afterwards in some cases (22%), a scar/cryo lesion was palpable. 28% of the patients reported pain, described as mild or moderate, compared to 2% after 1 year. Cosmetic results at 12 months follow-up were reported as good or excellent in 100% by physician and in 97% by patients. The cryodestruction of the FA using liquid nitrogen system proved functional and safe, while showing meaningful reduction in volume, palpability, pain and cosmetic satisfying outcomes.

Efficacy and safety of oral ketamine for the relief of intractable chronic pain: A retrospective 5-year study of 51 patients.

This work summarizes the efficiency, failures and adverse effects of oral administration of ketamine at home for intractable pain. This 5-year retrospective study involved testing ketamine by intravenous in-hospital administration, then a conversion to an oral route, or oral treatment directly administered at home. The daily intravenous dose was increased by steps of 0.5 mg/kg to attain an effective daily dose of 1.5-3.0 mg/kg. Pain was evaluated on a numeric scale from 0 to 10, and evidence of adverse effects was collected every day. The effective daily dose was delivered orally (three to four intakes). If effective, ketamine was continued for 3 months. Short infusions or direct oral treatment began with a 0.5-mg/kg dose, then the daily ketamine dose was increased in 15- to 20-mg increments. Among 55 cases (51 patients, neuropathic pain 60%), the mean effective oral dose was 2 mg/kg. Ketamine was effective in 24 patients (44%, mean pain reduction 67 ± 17%), partially effective in 20% (mean pain reduction 30 ± 11%), with a mean opioid sparing of 63 ± 32%, and failure in 22%. Half of the patients experienced adverse effects, but only eight had to stop treatment. For patients with opioid therapy, failure of ketamine was less frequent (7% vs. 36%; p < 0.02), with fewer adverse effects (33% vs. 68%; p < 0.01). Pain was reduced or abolished in two-thirds of patients under ketamine therapy; ketamine was effective for patients taking opioids and resulted in few adverse effects.

Cervical and cervicomedullary spinal cord stimulation for chronic pain: Efficacy and outcomes

BackgroundThe role for spinal cord stimulation (SCS) in the management of chronic spinal cord forms of pain involving cervical dermatomes or the cervicomedullary junction (CMJ) for facial pain remains largely uncharted. ObjectiveTo review outcomes with cervical and CMJ SCS performed by a single surgeon, with particular emphasis on complications and efficacy. MethodsAll patients that underwent cervical or CMJ SCS by the lead author were identified and follow-up obtained by telephone questionnaires. Patient demographics, surgical details, outcomes and complications for all patients identified were critically reviewed. ResultsOf 121 patients identified that underwent at least trial SCS, 100 underwent permanent lead implantation. Indications for cervical SCS included brachial plexus lesions (8), complex regional pain syndrome (33), degenerative disc disease (4), failed neck surgery syndrome (23), chronic radiculopathy (6) and post-herpetic neuralgia (PHN) (1); for CMJ SCS, indications included trigeminal deafferetiation pain (10), trigeminal neuropathic pain (4), PHN (4) and occipital neuralgia (7). Pain relief was greater along the extremities than axially, and less in the occipital area than in the head or face. Mean pain reduction averaged 56.6% at a mean follow-up of 4.2 years. Of 24 revision surgeries required, 8 were for presumed lead migration or fracture. Complications included 4 CSF leaks, 5 wound infections, and 4 cases of persistent numbness or pain. Pain relief lasted an average of 3.6 years. ConclusionCervical and CMJ SCS are safe and efficacious and may provide greater relief along the upper extremities than axially, and in the head rather than in the occipital region.

More Options for Geriatric Pain, Depression

ORLANDO – Duloxetine for the treatment of late-life depression missed its primary endpoint in a recent large randomized trial, but it did result in consistently significant clinical improvement, compared with placebo across numerous secondary outcome measures. The results overall provide a suggestion of antidepressant efficacy along with evidence of a meaningful reduction in pain in this elderly patient population, Dr. David C. Steffens observed at the annual meeting of the American Association for Geriatric Psychiatry. This was a multicenter, double-blind, placebo-controlled 24-week study. It included 296 patients age 65 years or older with major depressive disorder, a Montgomery-Asberg Depression Rating Scale score of 20 or above indicative of at least moderately severe depression, and a Mini-Mental Status Examination score of 20 or more. Participants were randomized 2-to-1 to duloxetine (Cymbalta) at either 60 mg/day or 120 mg/day, or placebo. The primary endpoint was change in the Maier subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17) at week 12, compared with placebo. The difference fell short of statistical significance at week 12, which was surprising given that the difference was significant at weeks 4, 8, 16, and 20. Moreover, significantly greater improvement in depressive symptoms as measured by the Geriatric Depression Scale was seen in the duloxetine group at weeks 2, 4, 8, 16, 20, and 24 – but once again, not at week 12, which was the point when the study allowed for dose adjustment from 60 mg/day to 120 mg/day, noted Dr. Steffens, professor and chairman of the department of psychiatry at the University of Connecticut, Farmington. Participants had baseline mild to moderate pain as reflected in their scores on the Brief Pain Inventory and Pain Numeric Rating Scale. The duloxetine-treated group showed significant improvement in pain severity and interference, compared with controls. That's an important finding given that close to two-thirds of patients with geriatric depression have comorbid pain that typically compounds their mood disorder. Prior trials of duloxetine have been shorter. In this one, the remission rate, as defined by a HAMD-17 score of 7 or less among patients on duloxetine at 60 mg/day for the full 24 weeks, was 66% by week 12 and 65% at week 24. Thus, if a patient wasn't in remission after 12 weeks at 60 mg/day, it was unlikely to happen with another 12 weeks on that regimen, and a dose increase to 120 mg/day may be warranted. Five patients discontinued duloxetine for serious adverse events, compared with one placebo-treated control. The most prominent duloxetine-related side effects were diarrhea and dizziness. Duloxetine-treated patients showed a small increase in heart rate and a modest decrease in blood pressure, issues that need to be considered in an elderly population at increased cardiovascular risk. One patient on duloxetine fell and sustained a hip fracture (Am J Geriatr Psychiatry 2014;22[1]:34-45). Dr. Steffens, who didn't participate in the duloxetine trial, highlighted another encouraging development in the treatment of late-life depression: a pooled subgroup analysis he and other investigators conducted using the data from three similar 14-week, prospective, randomized, double-blind trials of adjuvant aripiprazole (Abilify), compared with second-line antidepressant therapy in patients with major depressive disorder who had an incomplete response to standard antidepressant therapy. Their analysis included 679 patients younger than 50 years of age and 409 others aged 50–67 years. The older group was further subdivided by age: 50–55, 56–60, and 61–67 years. “Our goal was to generate some preliminary data. Industry has been less and less interested in thinking about atypical antipsychotics in the elderly because of the black box warnings. Our reasoning was any data that we can get that might support further study in this population of older adults makes sense,” the psychiatrist explained. Older patients on aripiprazole showed significantly greater improvement on the Montgomery-Asberg Depression Rating Scale at week 14 than placebo-treated controls. Their remission rate was 33%, compared with 27% in younger aripiprazole-treated patients (Int J Geriatr Psychiatry 2011;26[6]:564-72). These data are “as good as we have in terms of this particular research issue. We showed people are not keeling over from this therapy. We can at least say that among the few elderly patients we have here, we have preliminary data that this may be helpful and can be tolerated. There are some signals here. Subsequent studies looking at the older population are needed,” according to Dr. Steffens. In response to an audience question, Dr. Steffens said that in the 10 or 12 patients with late-life depression where he has tried using aripiprazole off-label at a starting dose of 1 or 2 mg/day he has had a fair degree of success. Dr. Steffens reported having no financial conflicts.