The cost-effectiveness of a treatment-based classification system for low back pain: design of a randomised controlled trial and economic evaluation

Abstract

BackgroundSystematic reviews have shown that exercise therapy and spinal manipulation are both more effective for low back pain (LBP) than no treatment at all. However, the effects are at best modest. To enhance the clinical outcomes, recommendations are to improve the patient selection process, and to identify relevant subgroups to guide clinical decision-making. One of the systems that has potentials to improve clinical decision-making is a treatment-based classification system that is intended to identify those patients who are most likely to respond to direction-specific exercises, manipulation, or stabilisation exercises.Methods/DesignThe primary aim of this randomised controlled trial will be to assess the effectiveness of a classification-based system. A sample of 150 patients with subacute and chronic LBP who attend a private physical therapy clinic for treatment will be recruited. At baseline, all participants will undergo a standard evaluation by trained research physical therapists and will be classified into one of the following subgroups: direction-specific exercises, manipulation, or stabilisation. The patient will not be informed about the results of the examination. Patients will be randomly assigned to classification-based treatment or usual care according to the Dutch LBP guidelines, and will complete questionnaires at baseline, and 8, 26, and 52 weeks after the start of the treatment. The primary outcomes will be general perceived recovery, functional status, and pain intensity. Alongside this trial, an economic evaluation of cost-effectiveness and cost-utility will be conducted from a societal perspective.DiscussionThe present study will contribute to our knowledge about the effectiveness and cost-effectiveness of classification-based treatment in patients with LBP.Trial registrationTrial registration number: NTR1176

Inter-rater reliability of a modified version of Delitto et al.’s classification-based system for low back pain: a pilot study

“…The experience in using Delitto et al's system 5 of the principal investigator and second rater was designated as 'expert' due to their participation in research involving the system and having used the system clinically. This designation is consistent with that in the study of Fritz et al 7 Relevant research experience involved the development of a randomized controlled trial 13 to assess the effectiveness of Delitto et al's system. 5 In the conduct of the randomized controlled trial, 8 the first rater (AA) assessed 150 patients according to the system and discussed the outcomes regularly with the second rater (HvH) who had used the system in clinical care for 2 years.…”

“…6,9,12 This has led to the suggestion that physical therapists who are familiar with the system can obtain a moderate level of inter-rater reliability. 13 However, this suggestion must be interpreted with caution, because these studies used small patient samples (30-45 patients) with consequently large 95% confidence intervals (CIs). Another issue that needs further evaluation is the finding of Stanton et al 6 that the inter-rater reliability may be lower for patients with an 'unclear classification' (i.e.…”

Impact of physical exercise on quality of life of older adults with depression or Alzheimer's disease: a systematic review

“…Among them, the quality-adjusted life years (QALY) index estimates quality years earned, whereas the disability-adjusted life years (DALY) index calculates years lost due to disability. 8,9 QoL, a ubiquitous concept, is associated with social, psychological, and functional factors. Therefore, an increased prevalence of depression and AD among the elderly may lead to lower QoL.…”

Analysis of Patient Outcomes Using the MyoKinesthetic System for the Treatment of Low Back Pain: A Case Series

“…More than 1000 randomized controlled trials of various interventions used for the management of LBP have been conducted, but the evidence from these trials is contradictory and inconclusive. [1][2][3] The lack of a gold standard for LBP diagnosis further complicates the problem. Advanced imaging detects many abnormalities in both asymptomatic and symptomatic individuals, which indicates that pathoanatomic structures may not always be responsible for symptoms.…”

“…5 Because of a complicated etiology, approximately 85% of LBP patients receive the vague diagnosis of nonspecific LBP. 2,3,[6][7][8][9] Many LBP studies lack favorable outcomes because of a heterogeneous population of nonspecific LBP patients and the focus on 1 intervention benefiting everyone. 2 In an effort to rectify this problem, classification systems were developed to match patients to an appropriate treatment based on criteria discovered during a triage process of clinical evaluation.…”