Differences in pain, function and coping in Multidimensional Pain Inventory subgroups of chronic back pain: a one-group pretest-posttest study

Contains fulltext : 97819.pdf (publisher's version ) (Open Access)BACKGROUND: Patients with non-specific back pain are not a homogeneous group but heterogeneous with regard to their bio-psycho-social impairments. This study examined a sample of 173 highly disabled patients with chronic back pain to find out how the three subgroups based on the Multidimensional Pain Inventory (MPI) differed in their response to an inpatient pain management program. METHODS: Subgroup classification was conducted by cluster analysis using MPI subscale scores at entry into the program. At program entry and at discharge after four weeks, participants completed the MPI, the MOS Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and the Coping Strategies Questionnaire (CSQ). Pairwise analyses of the score changes of the mentioned outcomes of the three MPI subgroups were performed using the Mann-Whitney-U-test for significance. RESULTS: Cluster analysis identified three MPI subgroups in this highly disabled sample: a dysfunctional, interpersonally distressed and an adaptive copers subgroup. The dysfunctional subgroup (29% of the sample) showed the highest level of depression in SF-36 mental health (33.4 +/- 13.9), the interpersonally distressed subgroup (35% of the sample) a modest level of depression (46.8 +/- 20.4), and the adaptive copers subgroup (32% of the sample) the lowest level of depression (57.8 +/- 19.1). Significant differences in pain reduction and improvement of mental health and coping were observed across the three MPI subgroups, i.e. the effect sizes for MPI pain reduction were: 0.84 (0.44-1.24) for the dysfunctional subgroup, 1.22 (0.86-1.58) for the adaptive copers subgroup, and 0.53 (0.24-0.81) for the interpersonally distressed subgroup (p = 0.006 for pairwise comparison). Significant score changes between subgroups concerning activities and physical functioning could not be identified. CONCLUSIONS: MPI subgroup classification showed significant differences in score changes for pain, mental health and coping. These findings underscore the importance of assessing individual differences to understand how patients adjust to chronic back pain

Chronic non-specific low back pain - sub-groups or a single mechanism?

Copyright 2008 Wand and O'Connell; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Low back pain is a substantial health problem and has subsequently attracted a considerable amount of research. Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches. Discussion: Many clinicians challenge the results of clinical trials as they feel that this lack of effectiveness is at odds with their clinical experience of managing patients with back pain. A common explanation for this discrepancy is the perceived heterogeneity of patients with chronic non-specific low back pain. It is felt that the effects of treatment may be diluted by the application of a single intervention to a complex, heterogeneous group with diverse treatment needs. This argument presupposes that current treatment is effective when applied to the correct patient. An alternative perspective is that the clinical trials are correct and current treatments have limited efficacy. Preoccupation with sub-grouping may stifle engagement with this view and it is important that the sub-grouping paradigm is closely examined. This paper argues that there are numerous problems with the sub-grouping approach and that it may not be an important reason for the disappointing results of clinical trials. We propose instead that current treatment may be ineffective because it has been misdirected. Recent evidence that demonstrates changes within the brain in chronic low back pain sufferers raises the possibility that persistent back pain may be a problem of cortical reorganisation and degeneration. This perspective offers interesting insights into the chronic low back pain experience and suggests alternative models of intervention. Summary: The disappointing results of clinical research are commonly explained by the failure of researchers to adequately attend to sub-grouping of the chronic non-specific low back pain population. Alternatively, current approaches may be ineffective and clinicians and researchers may need to radically rethink the nature of the problem and how it should best be managed

Facet joint injections for people with persistent non-specific low back pain (Facet injection study) : A feasibility study for a randomised controlled trial

All NIHR Journals Library reports have been produced under the terms of a commissioning contract issued by the Secretary of State for Health. Reports may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Permission to reproduce material from a published report is covered by the UK government’s non-commercial licence for public sector information. Applications for commercial reproduction should be addressed to the editorial office at: [email protected]: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. Objectives: To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. Design: The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Setting: Five NHS acute trusts in England. Participants: Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with ‘best usual care’ (BUC) or BUC alone. Interventions: All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Main outcome measures: Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Results: Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. Limitations: Poor recruitment was a limiting factor. Conclusions: This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain.Peer reviewe

Cost-effectiveness analysis of open colposuspension versus laparoscopic colposuspension in the treatment of urodynamic stress incontinence

OBJECTIVES To compare the cost effectiveness of laparoscopic versus open colposuspension for the treatment of female urinary stress incontinence. DESIGN Cost utility analysis alongside a randomised controlled trial. SETTING Six gynaecological surgical centres within the UK. POPULATION/SAMPLE Women with proven stress urinary incontinence requiring surgery. METHODS Open abdominal retropubic colposuspension or laparoscopic colposuspension carried out by experienced surgeons. MAIN OUTCOME MEASURES Cost, measured in pounds sterling and generic health-related quality of life, measured using the EQ-5D. The latter was used to estimate patient-specific quality-adjusted life years (QALYs). RESULTS Healthcare resource use over 6-month follow up translated into costs of £1805 for the laparoscopic arm and £1433 for the open arm (differential mean cost £372; 95% credibility interval [CrI]: 274–471). At 6 months, QALYs were slightly higher in the laparoscopic arm relative to the open arm (0.005; 95% CrI: −0.012 to 0.023). Therefore, the cost of each extra QALY in the laparoscopic group (the incremental cost-effectiveness ratio [ICER]) was £74,400 at 6 months. At 24 months, the laparoscopic arm again had a higher mean QALY score compared to the open surgery group. Thus, assuming that beyond 6 months the laparoscopic colposuspension would not lead to any significant additional costs compared with open colposuspension, the ICER was reduced to £9300 at 24 months. Extensive sensitivity analyses were carried out to test assumptions made in the base case scenario. CONCLUSIONS Laparoscopic colposuspension is not cost effective when compared with open colposuspension during the first 6 months following surgery, but it may be cost effective over 24 months

Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults

BACKGROUND: Chronic musculoskeletal pain (CMP) is a major health problem, accounting for approximately one-quarter of general practice (GP) consultations in the United Kingdom (UK). Exercise and physical activity is beneficial for the most common types of CMP, such as back and knee pain. However, poor adherence to exercise and physical activity may limit long-term effectiveness. OBJECTIVES: To assess the effects of interventions to improve adherence to exercise and physical activity for people with chronic musculoskeletal pain. SEARCH STRATEGY: We searched the trials registers of relevant Cochrane Review Groups. In addition, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, Science Citation Index and Social Science Citation Index and reference lists of articles to October 2007. We consulted experts for unpublished trials. SELECTION CRITERIA: Randomised or quasi-randomised trials evaluating interventions that aimed to improve adherence to exercise and physical activity in adults with pain for three months and over in the axial skeleton or large peripheral joints. DATA COLLECTION AND ANALYSIS: Two of the four authors independently assessed the quality of each included trial and extracted data. We contacted study authors for missing information. MAIN RESULTS: We included 42 trials with 8243 participants, mainly with osteoarthritis and spinal pain. Methods used for improving and measuring adherence in the included trials were inconsistent. Two of the 17 trials that compared different types of exercise showed positive effects, suggesting that the type of exercise is not an important factor in improving exercise adherence. Six trials studied different methods of delivering exercise, such as supervising exercise sessions, refresher sessions and audio or videotapes of the exercises to take home. Of these, five trials found interventions improved exercise adherence. Four trials evaluated specific interventions targeting exercise adherence; three of these showed a positive effect on exercise adherence. In eight trials studying self-management programmes, six improved adherence measures. One trial found graded activity was more effective than usual care for improving exercise adherence. Cognitive behavioural therapy was effective in a trial in people with whiplash-associated disorder, but not in trials of people with other CMP. In the trials that showed a positive effect on adherence, association between clinical outcomes and exercise adherence was conflicting. AUTHORS' CONCLUSIONS: Interventions such as supervised or individualised exercise therapy and self-management techniques may enhance exercise adherence. However, high-quality, randomised trials with long-term follow up that explicitly address adherence to exercises and physical activity are needed. A standard validated measure of exercise adherence should be used consistently in future studies

Identifying back pain subgroups: developing and applying approaches using individual patient data collected within clinical trials

Background There is good evidence that therapist-delivered interventions have modest beneficial effects for people with low back pain (LBP). Identification of subgroups of people with LBP who may benefit from these different treatment approaches is an important research priority. Aims and objectives To improve the clinical effectiveness and cost-effectiveness of LBP treatment by providing patients, their clinical advisors and health-service purchasers with better information about which participants are most likely to benefit from which treatment choices. Our objectives were to synthesise what is already known about the validity, reliability and predictive value of possible treatment moderators (patient factors that predict response to treatment) for therapist-delivered interventions; develop a repository of individual participant data from randomised controlled trials (RCTs) testing therapist-delivered interventions for LBP; determine which participant characteristics, if any, predict clinical response to different treatments for LBP; and determine which participant characteristics, if any, predict the most cost-effective treatments for LBP. Achieving these objectives required substantial methodological work, including the development and evaluation of some novel statistical approaches. This programme of work was not designed to analyse the main effect of interventions and no such interpretations should be made. Methods First, we reviewed the literature on treatment moderators and subgroups. We initially invited investigators of trials of therapist-delivered interventions for LBP with &gt;179 participants to share their data with us; some further smaller trials that were offered to us were also included. Using these trials we developed a repository of individual participant data of therapist-delivered interventions for LBP. Using this data set we sought to identify which participant characteristics, if any, predict response to different treatments (moderators) for clinical effectiveness and cost-effectiveness outcomes. We undertook an analysis of covariance to identify potential moderators to apply in our main analyses. Subsequently, we developed and applied three methods of subgroup identification: recursive partitioning (interaction trees and subgroup identification based on a differential effect search); adaptive risk group refinement; and an individual participant data indirect network meta-analysis (NWMA) to identify subgroups defined by multiple parameters. Results We included data from 19 RCTs with 9328 participants (mean age 49 years, 57% females). Our prespecified analyses using recursive partitioning and adaptive risk group refinement performed well and allowed us to identify some subgroups. The differences in the effect size in the different subgroups were typically small and unlikely to be clinically meaningful. Increasing baseline severity on the outcome of interest was the strongest driver of subgroup identification that we identified. Additionally, we explored the application of Bayesian indirect NWMA. This method produced varying probabilities that a particular treatment choice would be most likely to be effective for a specific patient profile. Conclusions These data lack clinical effectiveness or cost-effectiveness justification for the use of baseline characteristics in the development of subgroups for back pain. The methodological developments from this work have the potential to be applied in other clinical areas. The pooled repository database will serve as a valuable resource to the LBP research community.</p