Treatment of cancer-related pain with transdermal buprenorphine: a report of three cases

Three patients suffering from pain arising from renal and metastasing prostate and breast cancer were successfully treated with transdermal buprenorphine. The three cases demonstrate that transdermal buprenorphine is an easy-to-use and effective therapeutic option for the treatment of advanced cancer pain, that it can also be used in opioid rotation as an alternative after formerly applied steps II or III opioids have failed and that long-term treatment without dose escalation or compromise in tolerability is possible.     

Inefficacy of high-dose transdermal fentanyl in a patient with neuropathic pain, a case report.

Pain partially responsive to opioids can lead to rapid escalating dosages due to tolerance development. In this report the case of a 58-year-old female with neuropathic pain using increasing transdermal (TTS) fentanyl dosages to a maximum dose of 3400 microg/h resulting in fentanyl plasma levels of 173 ng/ml is described. For pain relief an epidural infusion at the level T1-2 with bupivacaine was started. Immediate pain relief was accompanied by short lasting respiratory depression and drowsiness.     

Safety of buprenorphine transdermal system in the management of pain in older adults

Objectives: To evaluate whether buprenorphine transdermal system (BTDS; Butrans®) is an option for the treatment of chronic pain in older adults.

Methods: This retrospective analysis of 16 placebo- and active-controlled and uncontrolled studies (N = 6566) evaluated the safety and tolerability profile in patients exposed to BTDS and compared the safety profiles associated with BTDS treatment in older patients ≥ 65 years of age (65 to 98 years) and younger patients < 65 years of age (18 to 64 years). Safety analyses included adverse events (AEs), laboratory values, and electrocardiograms.

Results: Overall, the incidence of AEs was similar in the ≥ 65 year patient cohort (N = 1715) and the < 65 year patient cohort (N = 4843) (63.8% and 61.0%, respectively). The older patient cohort experienced more constipation, peripheral edema, and urinary tract infection, but fewer application-site AEs (eg, erythema, irritation, pruritus, rash) and headaches. A statistically significant treatment-by-age interaction was observed for fall, arthralgia, and localized and non-application site-related rash, suggesting a differential increase in the risk of these events among older patients treated with BTDS that cannot be explained by age or treatment alone. A similar trend was observed for accidents and injuries, and for falls, in patients treated with both BTDS and active controls (oxycodone/acetaminophen [OXY/APAP] and hydrocodone/acetaminophen [HCD/APAP]), suggesting an opioid class effect. However, due to small sample sizes of the active control groups, a statistical test of treatment-by-age interaction could not be conducted for the active controls. The incidences of serious AEs and of clinically significant increases in liver enzymes, such as AST, ALT and bilirubin were small, regardless of age.

Conclusion: BTDS appears to be a viable option for the management of pain in older adults, but the benefits need to be tempered by potential risks among older adults.     

Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain

Objective: This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP). Methods: A post-hoc analysis used data from a randomized, placebo-controlled, double-blind trial of patients with moderate-to-severe CLBP. The Brief Pain Inventory (BPI) measured pain interference at screening, following a run-in period, and during the 12-week double-blind treatment phase. Statistical analyses examined treatment arm differences (BTDS vs placebo) for the following: BPI Interference subscale items and subscale scores at the trial end point (week 12); patterns of change in the Interference subscale scores over time; proportions of patients indicating mild or no interference following treatment; and proportions of patients showing improvement (30%, 50%, 2-point, or 4-point change in score from screening to week 12) for each item and subscale. Results: Mean scores for BPI Interference items and Interference subscale were significantly lower (ie, indicated less interference) for BTDS than for placebo (all P < 0.001). Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment. The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment (P < 0.05). For most comparisons, BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores (P < 0.05 for differences). Discussion: Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase.     

Effects of Qigong practice in office workers with chronic non-specific low back pain: A randomized control trial

ObjectiveTo investigate the effects of Qigong practice, Guan Yin Zi Zai Gong level 1, compared with a waiting list control group among office workers with chronic nonspecific low back pain (CNLBP).MethodsA randomized controlled trial was conducted at offices in the Bangkok Metropolitan Region. Seventy-two office workers with CNLBP were screened for inclusion/exclusion criteria (age 20–40 years; sitting period more than 4 h per day) and were allocated randomly into two groups: the Qigong and waiting list groups (n = 36 each). The participants in the Qigong group took a Qigong practice class (Guan Yin Zi Zai Gong level 1) for one hour per week for six weeks at their workstation. The participants were encouraged to conduct the Qigong exercise at home every day. The waiting list group received general advice regarding low back pain management. The primary outcomes were pain intensity, measured by the visual analog scale, and back functional disability, measured by the Roland and Morris Disability Questionnaire. The secondary outcomes were back range of motion, core stability performance index, heart rate, respiratory rate, the Srithanya Stress Scale (ST-5), and the global perceived effect (GPE) questionnaire.ResultsCompared to the baseline, participants in the Qigong group experienced significantly decreased pain intensity and back functional disability. No statistically significant difference in these parameters was found in the waiting list group. Comparing the two groups, Qigong exercise significantly improved pain intensity, back functional impairment, range of motion, core muscle strength, heart rate, respiratory rate, and mental status. The Qigong group also had a significantly higher global outcome satisfaction than the waiting list group.ConclusionQigong practice is an option for treatment of CNLBP in office workers.     

Efficacy of the Sustained-Release Hydromorphone in Neuropathic Pain Management: Pooled Analysis of Three Open-Label Studies

ABSTRACT

This pooled analysis was designed to determine whether the analgesic response to treatment with OROS® hydromorphone, as measured by the “pain on average” scale of the Brief Pain Inventory (BPI), was different in patients with neuropathic pain compared to those with nociceptive pain, after adjusting for differences in baseline characteristics. Three open-label studies on patients with neuropathic and nociceptive malignant and nonmalignant chronic pain were analyzed. A mixed model for repeated measures linear regression analysis was used to compare the effect of OROS® hydromorphone on patients with neuropathic and nociceptive pain, adjusting for potentially confounding factors. Data from patients with pure neuropathic pain and mixed pain were also compared. Safety and tolerability was assessed by recording the number of adverse events. The primary outcome was “pain on average” (BPI item 5) over time. Secondary outcomes were the effect of OROS® hydromorphone on other BPI items including “pain relief” and “interference with sleep.” Patients with neuropathic pain showed a similar response to treatment with OROS® hydromorphone to those patients with nociceptive pain. There was no statistically significant difference between the pain groups (difference between groups ?0.552 at visit 7; P = .060 for overall difference between groups). For some outcome variables, treatment was more effective for patients with neuropathic pain. The treatment was generally well tolerated. This pooled analysis shows that treatment with OROS® hydromorphone had similar efficacy for neuropathic and nociceptive pain.     

Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study

Context

This article presents the results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine. In this randomized, placebo-controlled study with an enriched enrollment design, the buprenorphine transdermal system (BTDS) was found to be efficacious and generally well tolerated.

Objectives

This enriched, multicenter, randomized, double-blind study evaluated the efficacy, tolerability, and safety of BTDS in opioid-naïve patients who had moderate to severe chronic low back pain.

Methods

Patients who tolerated and responded to BTDS (10 or 20 mcg/hour) during an open-label run-in period were randomized to continue BTDS 10 or 20 mcg/hour or receive matching placebo. The primary outcome was “average pain over the last 24 hours” at the end of the 12-week double-blind phase, collected on an 11-point scale (0 = no pain, 10 = pain as bad as you can imagine). Sleep disturbance (Medical Outcomes Study subscale) and total number of supplemental analgesic tablets used were secondary efficacy variables.

Results

Fifty-three percent of patients receiving open-label BTDS (541 of 1024) were randomized to receive BTDS (n = 257) or placebo (n = 284). Patients receiving BTDS reported statistically significantly lower pain scores at Week 12 compared with placebo (least square mean treatment difference: −0.58, P = 0.010). Sensitivity analyses of the primary efficacy variable and results of the analysis of secondary efficacy variables supported the efficacy of BTDS relative to placebo. During the double-blind phase, the incidence of treatment-emergent adverse events was 55% for the BTDS treatment group and 52% for the placebo treatment group. Laboratory, vital sign, and electrocardiogram evaluations did not reveal unanticipated safety findings.

Conclusion

BTDS was efficacious in the treatment of opioid-naïve patients with moderate to severe chronic low back pain. Most treatment-emergent adverse events observed were consistent with those associated with the use of opioid agonists and transdermal patches.     

Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain

Objectives: Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA^®) delivery technology. Buccal buprenorphine (BBUP; Belbuca^TM, Endo Pharmaceuticals) was evaluated for the management of moderate to severe chronic low back pain (CLBP) requiring around-the-clock analgesia in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-naive patients.

Methods: Patients (n = 749) were titrated to a dose of BBUP (range, 150–450 µg every 12 h) that was generally well tolerated and provided adequate analgesia for ≥14 days, and then randomized to BBUP (n = 229) or placebo (n = 232), respectively. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in the mean of daily average pain intensity scores (numeric rating scale from 0 [no pain] to 10 [worst pain imaginable]).

Results: Patients were experiencing moderate to severe pain at study entry: mean (SD) = 7.15 (1.05). Following titration, pain was reduced to the mild range; 2.81 (1.07). After randomization, mean (SD) pain scores increased from baseline to week 12 more with placebo (1.59 [2.04]) versus BBUP: (0.94 [1.85]) with a significant between-group difference (?0.67 [95% CI: ?1.07 to ?0.26]; p = 0.0012). A significantly larger percentage of patients receiving BBUP versus placebo had ≥30% pain reduction (63% vs 47%; p = 0.0012). During double-blind treatment, the most frequent adverse events (AEs) with BBUP were nausea (10%), constipation (4%) and vomiting (4%). The most common AEs with placebo were nausea (7%), upper respiratory tract infection (4%), headache (3%) and diarrhea (3%).

Conclusions: These findings demonstrate the efficacy and tolerability of BBUP among opioid-naive patients requiring around-the-clock opioid treatment for CLBP.     

Treatment of low back pain: monitoring clinical practice through audit

Objectives

Back pain is one of the most common causes of disability in the UK. Management guidelines for the treatment of acute back pain have been published. Auditing patients’ physiotherapy treatment records is one way of monitoring standards of care. Standards were developed using published evidence-based treatment, self-management guidelines and local standards within a physiotherapy outpatient department.

Design

Physiotherapy treatment notes for patients referred with low back pain were audited in 1996 (Audit 1). The audit was repeated in 2001 (Audit 2) after additional standards were implemented following the results of Audit 1.

Setting

Physiotherapy Outpatient Department, Addenbrooke's NHS Trust Hospital, Cambridge, UK.

Results

In Audit 1, 66% and 88% of patient records indicated that they were compliant with the standards for acute and chronic back pain, respectively. Sixty-four percent of patients were advised to keep active, 96% showed evidence of diagnostic triage, 65% showed evidence of mobilisation, none were recommended bed rest (100% compliance), and there was no evidence of manipulation. In Audit 2, 57% and 51% of patient records indicated that they were compliant with the standards for acute and chronic back pain, respectively. Thirty percent were considered to be yellow flags, 59% showed evidence of mobilisation, 100% showed evidence of diagnostic triage and did not recommend bed rest, 60% were referred for rehabilitation, and there was no evidence of manipulation. Changes instigated included new appointment and referral systems and new topics for staff education.

Conclusion

Auditing physiotherapy treatment notes of patients with low back pain has been shown to be useful in monitoring areas of good practice and in identifying practice in need of development. Clinical audit should be seen as a quality improvement process that aims to optimise patient care.     

Opioid Rotation from High-Dose Morphine to Transdermal Buprenorphine (Transtec®) in Chronic Pain Patients

Abstract:   Opioid rotation is increasingly becoming an option to improve pain management especially in long-term treatment. Because of insufficient analgesia and intolerable side effects, a total of 42 patients (23 male, 19 female; mean age 64.1 years) suffering from severe musculoskeletal (64%), cancer (21%) or neuropathic (19%) pain were converted from high-dose morphine (120 to >240 mg/day) to transdermal buprenorphine. The dose of buprenorphine necessary for conversion (at least 52.5 µg/h) was titrated individually by the treating physician. No conversion recommendations were given and the treating physician used his or her own judgment for dose adjustment. Pain relief, overall satisfaction and quality of sleep (very good, good, satisfactory, poor, or very poor), and the incidence and severity of adverse drug reactions over a period of at least 10 weeks and up to 1 year was assessed. Following rotation, patients experiencing good/very good pain relief increased from 5% to 76% ( P  < 0.001). Only 5% reported insufficient relief. Relief was achieved with buprenorphine alone in 77.4%, while 17% needed an additional opioid for breakthrough pain. Sleep quality (good/very good) increased from 14% to 74% ( P  < 0.005). Adverse effects were reported in 11.9%, mostly because of local irritation, did not result in termination of therapy. Neither tolerance nor refractory effect following rotation from morphine to buprenorphine was noted. Conversion tables with a fixed conversion ratio are of limited value in patients treated with high-dose morphine.     

Transdermal Buprenorphine for Central Neuropathic Pain: Clinical Reports

Transdermal buprenorphine is an effective analgesic for a variety of pain conditions. Traditionally, neuropathic pain is treated with medications such as tricyclic antidepressants or anticonvulsants, with opioid medications as second or third‐line agents. We present two different painful conditions of presumed neuropathic origin, with complex etiopathogenesis, which were successfully treated with buprenorphine. The results of treatment of these neuropathic pain syndromes with buprenorphine are encouraging, suggesting that it might represent a valid alternative to standard approaches for central neuropathic pain.     

某三级甲等医院临床护士腰痛情况调查与分析

目的：掌握临床护士腰痛发病情况以及相关职业因素,加强护士职业保护。方法：采用自行设计调查问卷对692名护士进行问卷调查。结果：护士腰痛发病率高达97.4%,年龄、护龄、夜班频度、弯腰频度、弯腰时间、科室的差异导致了腰痛频度的差异。结论：医院有关部门应重视护士腰痛的职业防护,促进护士身体健康。     

Acute low back pain: clinical course and prognostic factors

Purpose.?The aim of this study was to assess the clinical course of patients with acute low back pain (LBP) throughout 12 weeks and to identify the prognostic factors for non-recovery in the short term.

Method.?A total of 91 patients with acute LBP (<3 weeks) were included in this study. Baseline assessments including demographic variables, clinical characteristics of pain, lost work time and results of clinical examination were noted. Pain intensity, disability, general health perception and depression were assessed according to visual analogue scale, Roland Morris Disability Questionnaire (RMDQ), Nottingham Health Profile (NHP) and Beck Depression Inventory, respectively. Patients were assessed for pain intensity and disability at baseline, and at 1, 2, 4, 8 and 12 weeks of follow-up. Recovery was considered if patients scored <4 on the RMDQ and pain had resolved. At the 2nd week of follow-up, patients were divided into two groups according to recovery (Group 1) or non-recovery (Group 2) to identify the prognostic factors, which were analysed by multiple logistic regression.

Results.?At 2 weeks, 52 (57.1%) of the patients had recovered and only eight (8.7%) developed chronic LBP. Mean pain intensity and mean disability scores dropped 96.7 and 96.4%, respectively, of initial levels during the 12 weeks. Sixty per cent of 63 employed patients reported lost time from work. A comparison between groups revealed that finger-floor distance, RMDQ and NHP (pain, physical mobility, emotional reactions, sleep, energy level, and distress subgroups) were statistically significantly lower in Group 1, and NHP-pain was strongly associated with non-recovery in the short term.

Conclusions.?Acute LBP patients with disability generally recover in the first weeks. General health perception (NHP) – pain subgroup score was identified in particular as the best prognostic factor for non-recovery in the short term. Hence, pain should be given particular consideration in baseline assessments of acute LBP patients.