scholarly journals Are Invasive Procedures Effective for Chronic Pain? A Systematic Review

Pain Medicine ◽  
2018 ◽  
Vol 20 (7) ◽  
pp. 1281-1293 ◽  
Author(s):  
Wayne B Jonas ◽  
Cindy Crawford ◽  
Luana Colloca ◽  
Levente Kriston ◽  
Klaus Linde ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Knee Pain ◽  
Meta Analysis ◽  
Risk Difference ◽  
Biliary Colic ◽  
Low Back ◽  
Invasive Procedures ◽  
Moderate Amount

Abstract Objective To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures. Design Systematic review with meta-analysis. Methods Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected. Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation. Results Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham. Conditions included low back (N = 7 trials), arthritis (4), angina (4), abdominal pain (3), endometriosis (3), biliary colic (2), and migraine (2). Thirteen trials (52%) reported an adequate concealment of allocation. Fourteen studies (56%) reported on adverse events. Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%). In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = –0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = –0.11 to 0.19, P = 0.63, I2 = 36%). The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions. Conclusions There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain. Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

scholarly journals Arthroscopic partial meniscectomy for meniscal tears of the knee: a systematic review and meta-analysis

2019 ◽  
Vol 54 (11) ◽  
pp. 652-663 ◽  
Author(s):  
Simon G F Abram ◽  
Sally Hopewell ◽  
Andrew Paul Monk ◽  
Lee E Bayliss ◽  
David J Beard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Knee Pain ◽  
Surgical Intervention ◽  
Meta Analysis ◽  
Meniscal Tear ◽  
Meniscal Tears ◽  
Arthroscopic Partial Meniscectomy ◽  
Group A

ObjectiveTo assess the benefit of arthroscopic partial meniscectomy (APM) in adults with a meniscal tear and knee pain in three defined populations (taking account of the comparison intervention): (A) all patients (any type of meniscal tear with or without radiographic osteoarthritis); (B) patients with any type of meniscal tear in a non-osteoarthritic knee; and (C) patients with an unstable meniscal tear in a non-osteoarthritic knee.DesignSystematic review and meta-analysis.DatasourcesA search of MEDLINE, Embase, CENTRAL, Scopus, Web of Science, Clinicaltrials.gov and ISRCTN was performed, unlimited by language or publication date (inception to 18 October 2018).EligibilitycriteriaRandomised controlled trials performed in adults with meniscal tears, comparing APM versus (1) non-surgical intervention; (2) pharmacological intervention; (3) surgical intervention; and (4) no intervention.ResultsTen trials were identified: seven compared with non-surgery, one pharmacological and two surgical. Findings were limited by small sample size, small number of trials and cross-over of participants to APM from comparator interventions. In group A (all patients) receiving APM versus non-surgical intervention (physiotherapy), at 6–12 months, there was a small mean improvement in knee pain (standardised mean difference [SMD] 0.22 [95% CI 0.03 to 0.40]; five trials, 943 patients; I248%; Grading of Recommendations Assessment, Development and Evaluation [GRADE]: low), knee-specific quality of life (SMD 0.43 [95% CI 0.10 to 0.75]; three trials, 350 patients; I256%; GRADE: low) and knee function (SMD 0.18 [95% CI 0.04 to 0.33]; six trials, 1050 patients; I227%; GRADE: low). When the analysis was restricted to people without osteoarthritis (group B), there was a small to moderate improvement in knee pain (SMD 0.35 [95% CI 0.04 to 0.66]; three trials, 402 patients; I258%; GRADE: very low), knee-specific quality of life (SMD 0.59 [95% CI 0.11 to 1.07]; two trials, 244 patients; I271%; GRADE: low) and knee function (SMD 0.30 [95% CI 0.06 to 0.53]; four trials, 507 patients; I244%; GRADE: very low). There was no improvement in knee pain, function or quality of life in patients receiving APM compared with placebo surgery at 6–12 months in group A or B (pain: SMD 0.08 [95% CI −0.24 to 0.41]; one trial, 146 patients; GRADE: low; function: SMD −0.08 [95% CI −0.41 to 0.24]; one trial, 146 patients; GRADE: high; quality of life: SMD 0.05 [95% CI −0.27 to 0.38]; one trial; 146 patients; GRADE: high). No trials were identified for people in group C.ConclusionPerforming APM in all patients with knee pain and a meniscal tear is not appropriate, and surgical treatment should not be considered the first-line intervention. There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis. No trial has been limited to patients failing non-operative treatment or patients with an unstable meniscal tear in a non-arthritic joint; research is needed to establish the value of APM in this population.Protocol registration numberPROSPERO CRD42017056844.

scholarly journals A Systematic Review of the Effectiveness of Rehabilitation Therapy to Treat People with Chronic Knee Pain Following A Total Knee Replacement.

2020 ◽  
Author(s):  
Nathan Adam Johns ◽  
Justine Naylor ◽  
Brinda Thirugnanam ◽  
Dean Mckenzie ◽  
Bernadette Brady ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Chronic Pain ◽  
Total Knee Replacement ◽  
Knee Pain ◽  
Knee Replacement ◽  
Chronic Knee Pain ◽  
Total Knee ◽  
Full Text Screening

Abstract Background:Chronic knee pain after a total knee replacement has been estimated to affect 10 to 30% of patients and is related to dissatisfaction with surgery, reduced function and reduced quality of life. Rehabilitation is often prescribed in the subacute period post-operatively, but it may offer benefit to the increasing numbers of patients with chronic pain after their knee replacement. The aim of this systematic review is to evaluate the effectiveness of rehabilitation to improve pain, function and quality of life in people with chronic knee pain persisting for more than 3 months following a total knee replacement.Methods: The systematic review was conducted following PRISMA guidelines with a search of the online databases Ovid Medline, Embase via Ovid, CINAHL Plus, PsycINFO, Ovid Emcare and Proquest from their earliest date to July 12, 2020. The search criteria included English language randomised controlled trials of rehabilitation strategies in any setting to treat people with chronic knee pain, defined as knee pain persisting for more than 3 months, following a total knee replacement. Rehabilitation programs included exercise therapy, patient education, cognitive and mind-body strategies and self-management and excluded medication trials, procedural techniques and complementary therapies. Results:There were 254 abstracts screened for eligibility with 13 remaining for full-text screening. Following full-text screening, there were no studies that met the eligibility criteria for evaluating rehabilitation therapy to treat chronic knee pain persisting for more than 3 months following a total knee replacement.Conclusion:Despite the high volume of knee replacement surgery and the high incidence of moderate to severe chronic pain ensuing, there is currently no evidence available that rehabilitation commencing three months after surgery can effectively treat chronic pain and disability following a total knee replacement.

scholarly journals The Effect of Cognitive Functional Therapy for Chronic Nonspecific Low Back Pain: Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Takahiro Miki ◽  
Yu Kondo ◽  
Hiroshi kurakata ◽  
Eva Buzasi ◽  
Tsuneo Takebayashi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Low Back Pain ◽  
Back Pain ◽  
Functional Status ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Low Back ◽  
Functional Therapy

Abstract BackgroundTo apply the Bio-Psych-Social (BPS) model into clinical practice, it is important not to focus on psychosocial domains only since biomedical factors can also contribute to chronic pain conditions. The cognitive functional therapy (CFT) is the management system based on the BPS model for chronic nonspecific low back pain (CNSLBP). ObjectivesTo compare CFT with the other interventions for CNSLBP regarding pain, disability/functional status, QoL and psychological factors. DesignSystematic review and meta-analysis. MethodLiterature Search was conducted in electronic search engines. Enrolled participants included 1) CNSLBP and 2) primary, secondary, or tertiary care patients. CFT was the interventions included. Comparisons were any types of treatment. ResultsThree studies met the eligibility criteria. The total number of participants was 336. For pain intensity, MD [95% CIs] was -2.78 [-2.78−0.02] and -1.01 [-1.92−-0.10] at intermediate and long term for two studies, respectively. About disability/functional status, SMD [95% CIs] was -0.76 [-1.46−-0.07]　at the intermediate for three studies and MD [95% CIs] was -0.84 [-11.47−-5.49] at long term for two studies. About fear of physical activity, MD [95% CIs] was -3.01 [-5.14−-0.88] and -3.56 [-6.43−-0.68] at intermediate and long term for two studies, respectively. No studies reported scores associated with QOL. All the quality of the evidence was very low. ConclusionsThree studies were included and the quality of all the evidence was very low. Although the study found statistically significant differences in some measures, the effectiveness of the CFT will need to be re-evaluated in the future.PROSPERO registration number CRD42020158182

scholarly journals Do patients with chronic low-back pain experience a loss of health-related quality of life? A protocol for a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033396 ◽  
Author(s):  
Anna Coluccia ◽  
Andrea Pozza ◽  
Roberto Gusinu ◽  
Giacomo Gualtieri ◽  
Vitaliano Francesco Muzii ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Meta Analysis ◽  
Effect Sizes ◽  
Healthy Controls ◽  
Low Back ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

IntroductionHealth-related quality of life in chronic low back pain (LBP) is an important issue since various individual factors such as perceived loss of autonomy, inability to continue daily life and anxiety can contribute to maintenance or deterioration of this condition. Health-related quality of life is also important because it can predict the probability of recovery or recrudescence over time. In the literature, there is no systematic review on this topic. The present paper describes a protocol of the first systematic review and meta-analysis aimed at summarising the data on health-related quality of life in patients with chronic LBP compared with healthy controls. Gender, age and comorbidity of psychiatric disorders (mood or anxiety disorders) will be explored as moderators. Studies will be included if they used a case–control design comparing adults with chronic LBP to healthy controls on health-related quality of life through validated interviews/questionnaires.Methods and analysisAccording to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, a systematic review and meta-analysis will be conducted from 10th to 17th January 2020. Independent reviewers will search published/unpublished studies through electronic databases (Scopus, PubMed, EMBASE and the Cochrane Library) and additional sources, will extract the data and assess the methodological quality through the Newcastle-Ottawa Scale. Random-effect meta-analysis will be carried out by calculating effect sizes as Cohen’s d indices. Publication bias will be assessed and moderators of the effect sizes will be investigated through weighted least squares meta-regression.The knowledge whether health-related quality of life is better or worse as a function of some individual characteristics may suggest personalised care pathways according to a precision medicine approach.Ethics and disseminationThe current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals.PROSPERO registration numberCRD42019131749

scholarly journals Effectiveness of caregiver interventions for people with cancer and non-cancer-related chronic pain: a systematic review and meta-analysis

2021 ◽  
pp. 204946372110227
Author(s):  
Toby O. Smith ◽  
Matthew Pearson ◽  
Matthew J Smith ◽  
Jessica Fletcher ◽  
Lisa Irving ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Chronic Pain ◽  
Confidence Interval ◽  
Meta Analysis ◽  
Informal Caregivers ◽  
Mean Difference ◽  
Caregiver Interventions ◽  
Quality Evidence

Background: People with chronic pain frequently have difficulties in completing everyday tasks to maintain independence and quality of life. Informal caregivers may provide support to these individuals. However, the effectiveness of interventions to train and support these individuals in caregiving remains unclear. The purpose of this study was to systematically review the evidence to determine the effectiveness of caregiver interventions to support informal caregivers of people with chronic pain. Methods: A systematic review of published and unpublished literature databases was undertaken (9 April 2021). Trials reporting clinical outcomes of caregiver interventions to train informal caregivers to support community-dwelling people with chronic pain were included. Meta-analysis was undertaken and each outcome was assessed using Grading of Recommendations, Assessment, Development and Evaluation. Results: Twenty-seven studies were eligible (N = 3427 patients). Twenty-four studies assessed patients with cancer pain and three with musculoskeletal pain. No other patient groups were identified. There was very low-quality evidence that caregiver interventions were beneficial for caregiver health-related quality of life (standardised mean difference = 0.26, 95% confidence interval = 0.01 to 0.52; N = 231). There was moderate-quality evidence that caregiving interventions were effective in reducing pain in the short-term (standardised mean difference = 0.16, 95% confidence interval = −0.29 to −0.03). There was low-quality evidence that caregiving interventions had no beneficial effect over usual care for psychological outcomes, fatigue, coping or physical function in the long-term. Conclusion: Caregiving interventions may be effective for patients and caregivers but only in the shorter-term and for a limited number of outcomes. There is insufficient evidence examining the effectiveness of caregiver interventions for people with non-cancer-related pain.

scholarly journals Is Vitamin D Supplementation Effective for Low Back Pain? A Systematic Review and Meta-Analysis

2018 ◽  
Vol 1 (21;1) ◽  
pp. 121-145 ◽  
Author(s):  
Joshua Robert Zadro
Keyword(s):  
Systematic Review ◽  
Vitamin D ◽  
Low Back Pain ◽  
Back Pain ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Low Back ◽  
Pharmacological Interventions ◽  
Meta Analyses

Background: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Current intervention strategies are failing to reduce the enormous global burden of LBP and are prompting researchers to investigate alternative management strategies, such as vitamin D supplementation. Vitamin D supplementation appears to down regulate pro-inflammatory cytokines which lead to pain and up regulate anti-inflammatory cytokines that reduce inflammation. These mechanisms might explain the increasing interest in the use of vitamin D supplementation for LBP. Objectives: To determine whether vitamin D supplementation improves pain more than a control intervention for individuals with LBP. Study Design: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Methods: We performed searches in numerous electronic databases combining key words relating to “vitamin D” and “LBP” until March 2017. Studies were included if they investigated vitamin D supplementation in participants with LBP, provided there was a comparison intervention. There was no restriction on the type of LBP, the intervention parameters investigated, or the type of clinical trial (e.g., randomized, non-randomized). Two reviewers independently performed the selection of studies, extracted data, rated the methodological quality of the included studies, and evaluated the overall quality of the evidence using the Grading of Recommendations Assessment, Delevopment, and Evaulation (GRADE) approach. Results: After screening 3,534 articles, 8 clinical trials were included in this systematic review. There is very low quality evidence (based on the GRADE approach) that vitamin D supplementation is not more effective than any intervention (including placebo, no intervention, and other conservative/ pharmacological interventions) (continuous pain measures [0–100]: mean difference [MD] = -2.65, 95% confidence interval [CI]: -10.42 to 5.12, P = 0.504, n = 5; self-reported reduction in pain: pooled odds ratio [OR] = 1.07, 95% CI: 0.35 to 3.26, P = 0.906, n = 5) or placebo/no intervention for individuals with LBP (continuous pain measures: MD = 1.29, 95% CI: -3.81 to 6.39, P = 0.620, n = 4; self-reported reduction in pain: pooled OR = 1.53, 95% CI: 0.38 to 6.20, P = 0.550, n = 4), where ‘n’ is the number of studies included in the meta-analysis. These results did not change when we stratified the meta-analyses by the type of vitamin supplementation (vitamin D3 vs. alfacalcidol) or the type of LBP (non-specific vs. LBP resulting from osteoporosis or vertebral fractures). Limitations: The overall quality of evidence was “very low” due to the poor methodological quality and small sample sizes of the included studies. Conclusions: Vitamin D supplementation is not more effective than placebo, no intervention, or other conservative/pharmacological interventions for LBP (based on very low quality evidence). These results are consistent, regardless of the type of LBP or vitamin D supplementation. Until well-designed and adequately powered clinical trials suggest otherwise, the prescription of vitamin D for LBP cannot be recommended. PROSPERO Registration No: CRD42016046874. www.crd.york.ac.uk/PROSPERO/display_record. asp?ID = CRD42016046874 Key words: Vitamin D, low back pain, chronic low back pain, alfacalcidol, osteoporosis, vertebral fractures, serum 25-hydroxyvitamin D, systematic review

scholarly journals The Effect of Cognitive Functional Therapy for Chronic Nonspecific Low Back Pain: A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Takahiro Miki ◽  
Yu Kondo ◽  
Hiroshi Kurakata ◽  
Eva Buzasi ◽  
Tsuneo Takebayashi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Low Back Pain ◽  
Back Pain ◽  
Functional Status ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Low Back ◽  
Functional Therapy

Abstract Background: To apply the Bio-Psych-Social (BPS) model into clinical practice, it is important not to focus on psychosocial domains only since biomedical factors can also contribute to chronic pain conditions. The cognitive functional therapy (CFT) is the management system based on the BPS model for chronic nonspecific low back pain (CNSLBP). Objectives: To compare CFT with the other interventions for CNSLBP regarding pain, disability/functional status, QoL and psychological factors.Design: Systematic review and meta-analysis. Method: Literature Search was conducted in electronic search engines. Enrolled participants included 1) CNSLBP and 2) primary, secondary, or tertiary care patients. CFT was the interventions included. Comparisons were any types of treatment.Results: Three studies met the eligibility criteria. The total number of participants was 336. For pain intensity, MD [95% CIs] was -2.78 [-2.78−0.02] and -1.01 [-1.92−-0.10] at intermediate and long term for two studies, respectively. About disability/functional status, SMD [95% CIs] was -0.76 [-1.46−-0.07]　at the intermediate for three studies and MD [95% CIs] was -0.84 [-11.47−-5.49] at long term for two studies. About fear of physical activity, MD [95% CIs] was -3.01 [-5.14−-0.88] and -3.56 [-6.43−-0.68] at intermediate and long term for two studies, respectively. No studies reported scores associated with QOL. All the quality of the evidence was very low. Conclusions: Three studies were included and the quality of all the evidence was very low. Although the study found statistically significant differences in some measures, the effectiveness of the CFT will need to be re-evaluated in the future.PROSPERO registration number CRD42020158182

scholarly journals Ivermectin for Prophylaxis and Treatment of COVID-19: A Systematic Review and Meta-Analysis

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1645
Author(s):  
Mario Cruciani ◽  
Ilaria Pati ◽  
Francesca Masiello ◽  
Marina Malena ◽  
Simonetta Pupella ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Severe Pneumonia ◽  
Risk Difference ◽  
Serious Adverse Events ◽  
Treatment Protocols ◽  
Quality Of Evidence ◽  
Low Level ◽  
Clinical Trial Registries

Background. Ivermectin has received particular attention as a potential treatment for COVID-19. However, the evidence to support its clinical efficacy is controversial. Objectives. We undertook a new systematic review of ivermectin for the treatment and prophylaxis of COVID-19, including new primary studies, outcomes other than mortality, and grading the quality of the available evidence following the Cochrane guidance for methodology. Methods. We searched electronic databases, repository databases, and clinical trial registries (up to June 2021). The measure of treatment effect was risk difference (RD) with 95% confidence intervals (CIs). The GRADE system was used to assess the certainty of the evidence. Results. The review includes 11 RCTs (2436 participants). The certainty of the available evidence was quite low or very low due to risk of bias, inconsistency, and imprecision. When the analysis was limited to patients with baseline mild or moderate disease (8 reports, 1283 patients), there were no differences in mortality between ivermectin and control groups (low level of certainty); in patients with baseline severe diseases (3 reports, 304 patients), the use of ivermectin significantly decreased mortality compared to the controls (RD −0.17; 95% CIs, −0.24/−0.10; p = 0.00001; low level of certainty). In terms of disease progression (to severe pneumonia, admission to intensive care unit, and/or mechanical ventilation), the results were much the same. At day 14, the rate of patients with a negative RT-PCR test was 21% higher (from 5 to 36% higher) for ivermectin recipients than it was for the controls (low quality of evidence). Three studies (736 subjects) indicated that prophylaxis with ivermectin increased the likelihood of preventing COVID-19 compared to controls (low quality of evidence). Serious adverse events were rarely reported. Conclusions. There is limited evidence for the benefit of ivermectin for COVID-19 treatment and prophylaxis, and most of this evidence is of low quality. Further evidence is needed to fine-tune potential indications and optimal treatment protocols for ivermectin as a treatment for COVID-19.

scholarly journals Long-Term Effectiveness and Tolerability of Pain Treatment with Tapentadol Prolonged Release

2020 ◽  
Vol 1;24 (1;1) ◽  
pp. E75-E85
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Neuropathic Pain ◽  
Knee Pain ◽  
Prolonged Release ◽  
Low Back ◽  
State Of Health ◽  
Open Label

BACKGROUND: The central analgesic tapentadol prolonged release (PR) has proven effective and generally well tolerated in a broad range of chronic pain conditions. Long-term data of its use are still scarce. OBJECTIVES: To evaluate long-term effectiveness, tolerability, and safety of tapentadol PR in patients with severe chronic osteoarthritis (OA) knee pain or low back pain (LBP) who responded to tapentadol in 1 of 4 preceding 12-week phase 3b clinical trials. STUDY DESIGN: Open-label, uncontrolled, observational extension study of up to 72 weeks. SETTING: Fourteen centers in Spain. Protocol approval by the reference ethics committee for all the participating centers. METHODS: Eligible patients started the extension trial on the tapentadol PR dosage optimized for them in the preceding trial; dose adjustments were permitted throughout the extension. Treatment effectiveness outcomes included changes in pain intensity, sleep, state of health, quality of life, patient and clinician global impression of change, and patients’ satisfaction with treatment. Patients with OA knee pain also answered the Western Ontario and McMaster Universities OA index, and patients with LBP with a possible neuropathic pain component completed neuropathic pain-related questionnaires. RESULTS: Eighty-three patients were enrolled: 40 with OA knee pain, 43 with LBP. The full analysis set consisted of 81 patients. Mean pain intensity remained relatively stable over the 72-week extension period with mean increases from baseline of 0.44 (95% confidence interval [CI], -0.1,1.0; Numeric Rating Scale) for all patients, 0.2 (95% CI, -0.5, 0.9) for patients with OA, and 0.68 (95% CI, -0.2, 1.6) for patients with LBP. State of health and quality of life baseline ratings were maintained; overall impression of change was “improved.” Most patients (88.9%) reported at least good treatment satisfaction at the end of treatment. Mean daily tapentadol PR doses slightly increased from 313.3 ± 139.5 mg at baseline to 315.7 ± 140.1 mg at end of study. Uptitration was required for 8.4% of the patients, 4.8% had a dose reduction during the trial. Adverse events considered probably/likely or certainly related to tapentadol PR treatment by the investigator were documented for 18.1% of all patients, most commonly constipation (7.2%). Seven patients (8.4%) experienced adverse events leading to premature discontinuation. LIMITATIONS: An open-label design, stable concomitant analgesics (World Health Organization step I), and dose adjustments were allowed during the study. All patients had benefitted from tapentadol PR in preceding trials. CONCLUSIONS: Sustained pain relief and quality of life for up to 72 treatment weeks under relatively stable dosing, as well as the good safety profile, indicate the usefulness of tapentadol PR for patients who suffer from severe chronic OA knee pain and LBP with limited risk for tolerance development. KEY WORDS: Tapentadol prolonged release, extension study, long-term, chronic pain, osteoarthritis, low back pain, efficacy, safety

Sign in / Sign up

Export Citation Format

Share Document