The classification-based system used in this study was not effective for improving physical therapy care outcomes in a population of patients with subacute and chronic low back pain.
The results indicate that a course of TESIs followed by MDT may be able to avoid surgery in a substantial proportion of candidates for herniated lumbar disc surgery.
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
Study design: Observational inter-rater reliability study. Objectives: To examine: (1) the inter-rater reliability of a modified version of Delitto et al.'s classificationbased algorithm for patients with low back pain; (2) the influence of different levels of familiarity with the system; and (3) the inter-rater reliability of algorithm decisions in patients who clearly fit into a subgroup (clear classifications) and those who do not (unclear classifications). Methods: Patients were examined twice on the same day by two of three participating physical therapists with different levels of familiarity with the system. Patients were classified into one of four classification groups. Raters were blind to the others' classification decision. In order to quantify the inter-rater reliability, percentages of agreement and Cohen's Kappa were calculated. Results: A total of 36 patients were included (clear classification n523; unclear classification n513). The overall rate of agreement was 53% and the Kappa value was 0.34 [95% confidence interval (CI): 0.11-0.57], which indicated only fair inter-rater reliability. Inter-rater reliability for patients with a clear classification (agreement 52%, Kappa value 0.29) was not higher than for patients with an unclear classification (agreement 54%, Kappa value 0.33). Familiarity with the system (i.e. trained with written instructions and previous research experience with the algorithm) did not improve the inter-rater reliability. Conclusion: Our pilot study challenges the inter-rater reliability of the classification procedure in clinical practice. Therefore, more knowledge is needed about factors that affect the inter-rater reliability, in order to improve the clinical applicability of the classification scheme.
ObjectivesThe general consensus is that surgical treatment is advised when conservative methods fail in patients with lumbosacral radicular syndrome (LRS). Preliminary evidence from our pilot study indicates that combination therapy (mechanical diagnosis therapy and transforaminal epidural injections) can prevent surgical treatment in patients on the waiting list for surgery. The pilot study lacked a control group, and therefore, firm conclusions pertaining to effects could not be made. This study aims to determine if combination therapy, performed while being on the waiting list for lumbar herniated disc surgery, is effective and cost‐effective compared with usual care (i.e., no intervention while being on the waiting list) among patients with a magnetic resonance imaging (MRI)‐confirmed indication for a lumbar herniated disc surgery.MethodsA randomized controlled trial will be conducted with an economic evaluation. Patients aged 18 and above with incapacitating LRS, with leg pain and an MRI confirmed indication for lumbar disc hernia surgery, will be recruited from seven Dutch hospitals. While being on the waiting list for lumbar herniated disc surgery, patients will be randomized to either the combination therapy or usual care group. The primary outcome measure is the number of patients undergoing lumbar disc surgery during 12‐month follow‐up. Secondary outcomes include back and leg pain intensity (numeric pain rating scale), physical functioning (Roland Morris Disability Questionnaires‐23), self‐perceived recovery (global perceived effect), and health‐related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ‐5D‐5L) and 12‐Item Short Form Health Survey (SF‐12)). For the economic evaluation, societal and health care costs will be measured. Measurements moments are baseline, 1, 2, 4, 6, 9, and 12 months. Data will be analysed according to the intention‐to‐treat principle.ConclusionNo randomized controlled trials have evaluated the effectiveness and cost‐effectiveness of combination therapy compared with usual care in patients with an indication for lumbar herniated disc surgery, which emphasizes the importance of this study.
Abstract. STUDY DESIGN: Prospective cohort study. BACKGROUND: Although lumbar radiculopathy is regarded as a specific diagnosis, the most effective treatment strategy is unclear. Commonly used treatments include transforaminal epidural steroid injections (TESIs) and Mechanical Diagnosis & Therapy (MDT), but no studies have investigated the effectiveness of this combination. MDT differentiates pain centralization (C) from non-centralization (NC), which indicates good vs. poor prognostic validity respectively. OBJECTIVE: The main aims were 1) to determine changes in Mechanical Diagnosis and Therapy (MDT) pain response classifications after transforaminal epidural steroid injections (TESIs) in candidates for lumbar herniated disc surgery and 2) to evaluate differences in short and long term outcomes for patients with different pain response classifications. METHODS: Candidates for lumbar herniated disc surgery were assessed with a MDT protocol and their pain response classified as centralizing or peripheralizing. For this study,only patients were eligible who showed a peripheralizing pain response at intake. All patients then received TESIs and were reassessed and classified using the MDT protocol, into groups according to pain response (resolved, centralizing, peripheralizing with less pain and peripheralising with severe pain). After receiving targeted treatment based on pain response after TESIs, ranging from advice, MDT or surgery, follow-up assessments were completed at discharge and at 12 months. The primary outcomes were disability (Roland-Morris Disability Questionnaire [RMDQ] for Sciatica), pain severity in leg (visual analogue scale [VAS], 0-100) and global perceived effect (GPE). Linear mixed-models were used to determine between-groups differences in outcome. RESULTS: A total of 77 patients with lumbar disc herniation and peripheralizing symptoms were included. Patients received an average of 2 (SD 0.7) TESIs. After TESIs, 17 patients (22%) were classified as peripheralizing with continuing severe pain.
H. van Helvoirt et al. / Transforaminal epidural steroid injections influence MDT pain response classificationThese patients underwent surgery and were not further evaluated. Eleven (14%) patients were classified as resolved, 37 (48%) as centralizing with significant less pain, and 12 (16%) as peripheralizing with significant less pain. None of these patients underwent surgery. Resolved and centralizer subgroups had better outcomes in terms of VAS and RMDQ than the non-operated peripheralizers at discharge and at 12 months. The succes rates (GPE) for the resolved, centralizing, and peripheralizing with less pain patients were 100%, 100% and 33% respectively at short term, and 100%, 92% and 50% respectively at long term. CONCLUSION: After TESIs, a peripheralizing pain pattern changed to resolved or centralizing in 62% of the patients. For the non-operated patients, those with a centralising pattern after TESIs reported better pain and disability outcomes than those with peripheralizing pattern at short ...
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