Critical Appraisal Practice Part II Assignment Purpose: Practice appraising the

Critical Appraisal Practice Part II Assignment Purpose: Practice appraising the trustworthiness of quantitative research. Appraising evidence in published literature is a multi-step process. This second part of the appraisal process provides a systematic approach to reading and appraising the methods, results, discussion, and conclusions of a research study. Continue this process with the quantitative research study introduced in Week 2 and used in Week 4 of this course. To prepare for this assignment Reviewed Chapter 4 in the textbook Read Chapter 5 in the textbook Reviewed Week 4 video: Reading a Research Study Reviewed feedback from the Week 4 Critical Appraisal Practice-Part I assignment Checked your knowledge with the Week 5 Quiz Reviewed Tables 5-2, 5-4, 5-5 Accessed the sample research study for this assignment. Instructions: Read the sample research study. Complete the table below based on the information you gather from the research article. In the Rationale sections, be sure to include specific information or examples from the study. Article Section Content Questions Appraisal: Check one box Methods Research Design Is the design selected in alignment with the purpose? Is the design appropriate to reach the stated outcome? Is a control or comparison group used when its use strengthens the validity of the outcome? Are the researchers blind to the assignment of participants (when it makes sense)? Are the participants blind to their assignment (when it makes sense)? Does the design limit the number of extraneous variables? ___ Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Methods Sample Did the authors describe the population that the sample is intended to represent? Was the sampling frame used appropriate for the purpose of the study? Were the inclusion and exclusion criteria clearly described and was it appropriate for the intended outcome? Was the assignment of participants to treatment and control/comparison groups random or nonrandom and was the method appropriate? Was the sample size sufficient to include all applicable variability? Was a sampling calculation discussed? ___ Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Methods Research Protocol Was the protocol for conducting the study described thoroughly and in enough detail? Was the protocol followed appropriate for the purpose? Did the study continue long enough to have valid outcomes? Was the protocol consistently administered to the participants in each group? Did the researchers take steps to control for extraneous variables? Was the protocol ethical and approved by an Institutional Review Board (IRB)? ___ Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Methods Data Collection Were data collection methods appropriate for the intended purpose of the study? Were data collection procedures consistently applied to the participants? Was the validity and reliability of the data collection instrument established at a high enough level? Was the reliability of the data collectors established at a high enough level? ___Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Results Sample Were important demographics of the intervention and control/comparison group similar and if not, did it impact the results? Were treatment and control groups similar at the baseline measurement of the outcome variables and if not, did this difference impact the results? How were eligible participants accounted for throughout the study? Was the discontinuance rate comparable between the treatment and control or comparison group? ___Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Results Data Analysis What did the power analysis indicate? Were data analyzed using an on-protocol or intention to treat analysis or both? If intention to treat analysis was used, what method was used to input missing data? Were the statistical analyses appropriate for the level of data (nominal, ordinal, interval or ratio)? Were the statistical analyses appropriate to test the hypotheses and answer the research questions? ___Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Results Findings Are findings presented relative to each hypothesis and research question? Are findings reported as statistically significant or not significant? When confidence levels are reported, are the upper and lower limits acceptable to implement a change to your practice? Do the findings have practical or clinical significance? ___Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Discussion Did the researchers thoroughly explain their interpretation of the findings? Were the explanations logical? Did the researchers compare their findings to the findings of previous studies and provide a rationale on why they differ? Do the researchers thoroughly identify and discuss the limitations? What are the implications for practice? What future research recommendations are made? ___Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Conclusions Is a conclusion provided for the intended purpose of the study? Do the conclusions logically follow from the findings and interpretation? ___Strength ___Limitation ___Not Evident ___Not Applicable Rationale: Article Randomized study of the impact of a therapeutic education program on patients suffering from chronic low-back pain who are treated with transcutaneous electrical nerve stimulation Thomas Garaud, MDa , Christine Gervais, CRNAb , Barbara Szekely, MDa,b, Mireille Michel-Cherqui, MDa,b, Jean-François Dreyfus, MDc , Marc Fischler, MDa,∗ Abstract Background: Transcutaneous electrical nerve stimulation (TENS) is often used for the treatment of low-back pain (LBP). However, its effectiveness is controversial. Objective: To determine the efficacy of TENS in the treatment LBP when associated to a therapeutic education program (TEP). Design: Open randomized monocentric study. Setting: University hospital between 2010 and 2014. Patients: A total of 97 patients suffering from LBP. Interventions: Routine care (TENS group) or routine care plus a therapeutic education program (TENS-TEP group) based on consultation support by a pain resource nurse. Main outcome measures: EIFEL and Dallas Pain Questionnaire scores. Results: Twenty-two patients (44%) were still assessable at the end-of-study visit, whereas 33 (70%) were assessable at the same time point in the TENS-TEP group (P=.013). The EIFEL score and the Dallas score had a similar evolution over time between groups (P=.18 and P=.50 respectively). Similarly, there were no significant differences between the groups with respect to resting pain scores (P=.94 for back pain and P=.16 for leg pain) and movement pain scores (P=.52 for back pain and P=.56 for leg pain). At Month 6, there was no significant difference between the groups (P=.85) with regard to analgesics and social impact. Two patients presented a serious adverse event during the study (one in each group) but non-attributable to the treatment studied. Conclusion: This study does not support the use of TENS in the treatment of patients with chronic LBP even though patients benefited from a therapeutic education program by a pain resource nurse. However, the higher number of premature withdrawals in the TENS group may be due to early withdrawal of patients who did not experience improvement of their symptoms. Abbreviations: LBP = low-back pain, TENS = transcutaneous electrical nerve stimulation, TEP = therapeutic education program. Keywords: back pain, therapeutic education program, transcutaneous electrical nerve stimulation Editor: Devrimsel Harika Ertem. Funding source: Funding was provided by the Nursing and Paramedical Hospital Research Program of the French Ministry of Health (PHRIP 2010) and by Hôpital Foch, Suresnes, France. Registration of the study in a public registry: Clinical.trial.gov site (NCT02564185). Implication Statement: The overall results of this study do not support the use of transcutaneous electrical nerve stimulation (TENS) in the treatment of patients with chronic low-back pain (LBP) even when patients benefit from a therapeutic education program (TEP) performed by a pain resource nurse. Supplemental Digital Content is available for this article. Financial support and sponsorship: Funding was provided by the Nursing and Paramedical Hospital Research Program of the French Ministry of Health (PHRIP 2010) and by Hôpital Foch, Suresnes, France. The authors have no conflicts of interest to disclose. aDepartment of Anesthesiology, Hôpital Foch, Suresnes, France and Université Versailles Saint-Quentin en Yvelines, b Pain Management Unit, Hôpital Foch, cClinical Research Unit, Hôpital Foch, Suresnes, France. ∗ Correspondence: Marc Fischler, Service d’Anesthésie, Hôpital Foch, 40 rue Worth, Suresnes 92151, France (e-mail: m..r@hopital-foch.org). Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Medicine (2018) 97:52(e13782) Received: 25 April 2018 / Accepted: 30 November 2018 http://dx.doi.org/10.1097/MD.0000000000013782 Clinical Trial/Experimental Study Medicine® OPEN 1 1. Introduction Gunnar BJ Andersson specified the epidemiological features of chronic low-back pain (LBP) in 1999, and this work remains valid.[1] This work stated that “70 to 85% of all people have back pain at some time in life. The annual prevalence of back pain ranges from 15% to 45%, with point prevalence averaging 30%. In the USA, back pain is the most common cause of activity limitation in people younger than 45 years, the 2nd most frequent reason for visits to the physician, the 5th-ranking cause of admission to hospital, and the 3rd most common cause for surgical procedures. Approximately 2% of the US workforce are compensated for back injuries each year.” The definition of the term, “chronic” is itself disputed and it has been proposed that acute back pain corresponds to a pain lasting less than 6 weeks, subacute to a pain lasting 7 to 12 weeks, and chronic pain to a pain ≥ 3 months.[2] Many treatments have been proposed, starting with non-steroidal anti-inflammatory drugs and opioids alone or in association with paracetamol.[3] The American College of Physicians and the American Pain Society recommend the use of non-drug therapies for patients who do not improve with conventional treatments. These therapies include intensive rehabilitation, physical exercise, acupuncture, massage therapy, spinal manipulation, yoga, and cognitive-behavioral therapy.[4] Transcutaneous electrical nerve stimulation (TENS) is one of the oldest techniques for the treatment of LBP,[5] particularly chronic LBP.[6] However, its effectiveness is controversial. A systematic review of the Cochrane database published in 2005 concluded that “There is inconsistent evidence to support the use of TENS as a single treatment in the management of chronic LBP”. [7] In addition, another Cochrane review published by the same authors 3 years later concluded that “the small number of placebo-controlled trials does not uphold the use of TENS in the management of chronic low-back pain.[8] This latter review, which included 4 randomized clinical trials involving 585 patients, did not find robust evidence of TENS efficacy with respect to pain, functional status or occupational status. Some of the failures of TENS could be explained by the lack of training of patients who are often left alone with the device after a brief explanation of its use and therapeutic benefits. Thus, a specialized nurse consultation could improve the clinical benefit provided by TENS, as suggested by Gladwell et al who report a short series of nine patients who benefited from training in the use of equipment (electrode placement and TENS settings).[9] The objective of this open randomized trial in patients with chronic LBP was to compare the efficacy of TENS alone and TENS in combination with a therapeutic education program (TEP) performed by a pain resource nurse. The hypothesis was that TENS in combination with TEP provides a better quality of life and functional status than TENS alone. 2. Methods This open randomized, monocentric trial was approved by the Ethical Committee Ile-de-France VIII (8/01/2010) and published on the Clinical.trial.gov site (NCT02564185). Eligible patients were included after reading an information sheet detailing the protocol and being given the opportunity to clarify remaining issues with the clinician. After written informed consent was obtained, each patient was assigned to either the Control group (TENS group) or the experimental group (TENS-TEP group) according to a randomization list generated by a computer and delivered by means of sealed envelopes. Randomization was balanced 1:1 between the 2 groups for blocks of size 2, 4 or 8 patients in a random sequence. 2.1. Study Population Patients ages from 18 to 75 years, covered by a national health insurance policy, who had consulted the pain center for persistent chronic LBP (pain lasting for at least 3 months), with or without radicular pain, were included in this study if they required TENS despite receiving appropriate medical treatment. Patients were ineligible for the study if they had a contraindication to TENS (epilepsy, pregnancy, wearing a pacemaker, an allodynia area, electrode allergy); if they had used TENS before their enrolment; if they had a mental, sensory or cognitive disorder; if they lacked autonomy or were living alone without home help; and if they were involved in other pain management research. Patients were excluded from the study in the following cases: nonresponse to the telephone survey, absence from more than one consultation, and nonresponse to at least 3 out of 5 questionnaires in the study. 2.2. Study protocol Table 1 summarizes the study protocol, especially the time points at which the outcome measures were assessed. In both the groups, patients underwent a medical consultation by a pain physician and an initial 1-h nursing consultation to Table 1 Study protocol. Inclusion M1 M3 M6 Groups TENS PRN X Pain physician X X X X TENS-TEP PRN X X X X Pain physician X X X X Measures EIFEL score X X X X Dallas Pain Questionnaire X X X X Pain scores X X X X DN4 X X X X Therapeutics X X Social impact X X Evaluation of the PRN’s intervention X Safety XXX DN4=neuropathic pain score, M1, M3, and M6: 1st, 3rd, and 6th month of treatment, respectively, PRN=pain resource nurse, TENS=group of patients treated with transcutaneous electrical nerve stimulation, TENS-TEP=group of patients treated with transcutaneous electrical nerve stimulation in combination with a therapeutic education program Garaud et al. Medicine (2018) 97:52 Medicine 2 establish a therapeutic plan. This consultation included the following points: clear, understandable and appropriate information that was provided in a progressive manner; a structured interview to explore the patient’s socioprofessional, cognitive and psychoaffective dimensions; a description of the mechanisms of pain, TENS technique and practical aspects of TENS use (choice of programs, number, location, and positioning of the electrodes, number of sessions per day, session duration, intensity, maintenance of the device, and the action to be taken in the event of an allergy); and a test session during which the most suitable program for treating pain was presented to the patient, with an explanation of the different possible adjustments: placement of the electrodes, session duration, intensity adjustment, and types of program (3 to 4 daily sessions of 1 to 2 h, continuous application in cases of incessant pain, preventive application before movements likely to cause pain). On the day of study enrolment, the patient’s demographic data, clinical history, and ongoing analgesic, co-analgesic and other medication were recorded. The patient independently completed a self-evaluation questionnaire, including the EIFEL scale of functional disability (RolandMorris questionnaire), and the Dallas pain self-questionnaire. The EIFEL scale has been validated for the evaluation of patients suffering from acute and chronic LBP. The scale assesses the effects of lumbar pain on the following activities of everyday life: locomotion, domestic activities, physical comfort, and social or psychological repercussions. A score of 0 refers to the absence of disability, and the maximum score of 24 corresponds to a major disability.[10] The Dallas self-questionnaire explores the impact of pain in 4 dimensions: daily activities, work and leisure activities, anxiety and depression, and social interest.[11] The DN4 Neuropathic Pain Diagnostic Questionnaire was also completed on the day of inclusion,[12] and the levels of back and leg pain at rest and during mobilization during the week preceding the consultation were recorded using a simple numerical scale ranging from 0 (absence of pain) to 10 (maximum imaginable pain). The patient was given a personal diary which contained detailed instructions on self-administering the TENS treatment, including an electrode location diagram depicting the correct placement of the electrodes. 2.3. TENS apparatus and procedure Two rectangular 90 x 45-mm electrodes were placed on healthy skin on each side of the painful area, and 2 additional electrodes were placed on the trajectory of the troncular nerve involved in the radiculopathy if present. The TENS (Primo Pro, Cefar Medical Ab, Malmo, Sweden) was administered using a conventional program (‘gate control’) characterized by continuous stimulation at high frequencies (80-100Hz) with wave durations of 50 to 100ms and low intensities, potentially achieving painless paresthesia in the part of the body that was treated. A ‘Burst’ TENS program (acupuncture-like TENS), characterized by discontinuous stimulation at low frequencies (1- 4Hz) with wave durations of 100 to 400ms and high intensities to induce weak muscle twitches, could be used during the test phase. 2.4. Outcome measures The primary study objectives were to evaluate the efficacy of the TEP in terms of quality of life and functional status assessed using the EIFEL score and the Dallas Pain Questionnaire. The secondary outcomes were the pain scores and DN4 score, the modification of treatments, the evaluation of the social impact, and the patient’s satisfaction with the intervention of the nurses which explores four subdomains: knowledge, practical issues, adaptation, and assessment of the program content. Since the number of completed questionnaires was limited, when some items were missing, the response was interpolated based on the majority rule for the available answers of the patient for the relevant subdomain. Finally, the potential adverse effects of TENS were recorded. 2.5. Statistical analysis Based on a cursory analysis of the literature, we hypothesized that the coefficient of variation for the EIFEL score was approximately 0.33. We hypothetized that compared with TENS alone, adding TEP to TENS would improve the EIFEL score at 6 months by approximately 20%. On this basis with an alpha risk of 5%, it was calculated that 50 patients per treatment group would be needed to achieve an 80% power to detect the expected difference between the groups using a t test. Given that a mixed model could be used if valid and is more powerful than a t test, the sample was expected to accommodate common levels of attrition. Categorical variables are presented as counts and percentages. Fisher’s exact test, which was generalized if needed to a 2n matrix, was used for between-group comparisons. Continuous variables are displayed as means±standard deviations or medians with interquartile ranges, depending on the normality or non-normality of distributions. Between-group comparisons of continuous variables were performed with a mixed model for repeated measures. The model included 2 fixed factors (Randomization group and Time), 1 covariable (Pretreatment value, since there were some beweengroup initial differences) and an interaction term (Group Time), which allows for the assessment of a difference in evolution. The variance-covariance matrix was assumed to be diagonal. The model provides means that are adjusted at the covariate means. An analog model was used to analyze secondary outcomes. For the medication and social status data, the PERMANOVA methodology (Primer, Version 7, Quest Research Ltd, Auckland, NZ) was used to test between-group differences based on discrete variable evolution. A between-case multivariate resemblance coefficient (c) for all types of medications or social statuses was used. Such coefficients carry a variance that may be partitioned according to the chosen model. An interaction term was used to assess differences in evolution across time. This partitioning may be tested by randomly permuting data across factors, which provides a probability of finding values that are more extreme than the values actually recorded. Ten thousand permutations were performed, which guarantees the validity of the probability at least to its 2nd decimal. Such a method does not require testing for sphericity, as changes in variance across time are treated as a treatment-related effect.[13] All analyses were performed using the intent-to-treat paradigm (i.e., patients were analyzed according to the group to which they were allocated by randomization). There was no attempt to impute data for patients lost to follow-up. Bilateral P < .05 were considered statistically significant. Analyses were performed with the statistical packages NCSS Garaud et al. Medicine (2018) 97:52 www.md-journal.com 3 (version 11), SPSS (version 20), Primer (version 7) and R (version 3.2.1). The dataset analyzed during the present study is available in the Dryad repository (https://datadryad.org/). 3. Results A total of 97 patients were included in the trial from Sept. 28, 2010, to Nov. 6, 2014. In the TENS group (Control), 50 patients started the study, and 22 (44%) were still assessable at the 4th (end-of-study) visit. In the TENS-TEP group, 47 patients started the trial, and 33 (70%) were assessable at the 4th visit (P=.013, Fig. 1). The main characteristics of the study patients are presented in Table 2. The EIFEL score had a similar evolution over time between groups (P=.18, Fig. 2). At Month 6, the median EIFEL score was 7.0 [4.010.2] in the TENS group and 8.0 [6.511.5] in the TENS-TEP group (P=.12). At the same time point, a decrease of 5 points in the EIFEL score, which is considered to indicate functional improvement,[14] was noted in 59.1% of the patients in the TENS group versus 48.5% of the patients in the TENS-TEP group (P=.58). The evolution of the global Dallas score did not differ significantly between groups (P=.50, Fig. 3). At Month 6, the median global Dallas score was 28.6 [22.454.5] in the TENS group compared with 30.2 [18.746.0] in the TENS-TEP group (P=.30). No significant between-group differences were noted in the four sub-scores of the Dallas Pain Questionnaire at 6 months (Table 3). Regarding evolution of pain during the period of the study, there were no significant differences between the groups with respect to resting pain scores (P=.94 for back pain and P=.16 for leg pain) and movement pain scores (P=.52 for back pain and P=.56 for leg pain) (Fig. 3). No significant differences in the DN4 score were noted between the TENS and the TENS-TEP groups (P=.95). At Month 6, there was no significant difference between the groups (P=.85) for analgesics (i.e., paracetamol, non-steroidal anti-inflammatory drugs, antidepressants, antiepileptic agents, myorelaxant agents and weak opioid drugs) and other treatment, such as 5% lidocaine plaster. At Month 6, there was no significant difference between the groups (P=.59) for social impact (full-time work, part-time work, sick leave, unable to work, retired, and unemployed). Thirty-six patients answered the questionnaire evaluating the intervention of the nurses (13 patients in the TENS Group and 23 in the TENS-TEP group). None of the results for each subdomain were statistically significant: knowledge (betweengroup: P=.98; between visits: P=.07); practical issues (between-group: P=.47; between visits: p=.19); adaptation (between-group: P=.80; between visits: p=.021); assessment of the program content (between-group: P=.52; between visits: P=.12). None of the interaction terms were significant. Two patients presented a serious adverse event during the study (one in each group). None of these events were attributable to the treatment studied. Skin irritation was observed in 2 patients in the TENS-TEP group. Finally, there is no significant difference in any characteristic when patients included in the study are compared to those who completed the study except for the intensity of low back pain while moving as assessed by physician (P=.04) while this difference was not present for the nurse assessment of the same parameter. A Supplementaryfile contains the statistical analysis used for this comparison and the Table of results. http://links.lww.com/MD/C713 4. Discussion Our negative results suggest the ineffectiveness of TENS in our population; in such a situation, adding therapeutic education did Between September 28, 2010, and November 6, 2014 Assessed for eligibility (n=100) Excluded (n=3) Analysis for the main outcome (n=33) Analysis for the main outcome (n=22) Randomized (n=100) TENS TENS-TEP Inclusion visit 1-month visit 3-month visit 6-month visit 50 patients 41 patients 33 patients 22 patients 47 patients 46 patients 39 patients 33 patients Figure 1. Flow chart, TENS: Group of patients treated with transcutaneous electrical nerve stimulation, TENS-TEP: Group of patients treated with transcutaneous electrical nerve stimulation in combination with a therapeutic education program. Garaud et al. Medicine (2018) 97:52 Medicine 4 not lead to a beneficial effect. As the analysis was impacted by the large number of patients lost to follow-up, it is important to note the significant difference in the number of patients who completed the study between the groups. Since TENS was not shown to be effective, we can assume that the patients of the TENS group who were dissatisfied with the device left the study earlier than the TENS-TEP group patients who remained in the study because they had a coaching relationship with a nurse. Chronic LBP is a classic indication for TENS. The Swedish Council on Health Assessment in Health Care (SBU) report included 4 randomized trials comparing TENS with placebo, 3 of which were of good quality.[15] These studies included the study by Deyo et al. who reported similar analgesic and functional efficacy,[16] and that by Marchand et al, who concluded that TENS was more effective in treating pain but only in the short term.[17] A new meta-analysis of 13 studies and 267 patients with an average follow-up of 7 weeks was recently published. The study reports a significant but transient improvement in LBP, but the effect is not evident after the 5th week of treatment.[18] Gladwell et al[9] described the problems with TENS use reported by experienced TENS users as follows: connectivity (pad adhesion, wires), fitting the TENS device (reaching to fit the pads and clothing), availability (portability and accessibility), sensation and settings (sensation of TENS and the controls), and visibility (device or wires visible to other people). A TEP, i.e., pain resource nurse consultations, could enhance any potential benefits of TENS or at least minimize any obstacles to its use. From this point of view, our pain resource nurse focused on the questions assessing the use of the device and not on providing better information on chronic LBP. Therapeutic education is now recognized as an essential part of the management of patients with a chronic pathology. The World Health Organization (WHO) defined therapeutic education in its report published in 1996 (Therapeutic Patient Education— Continuing Education Programs for Health Care Providers in the field of Chronic Disease) as follows: "therapeutic education aims to help patients acquire or maintain the skills they need to manage their lives with a chronic illness". Although the implementation of TEPs is very different, a literature review of Table 2 Patients characteristics at inclusion. TENS group n=50 TENS-TEP group n=47 Sex ratio (men/women) 9/41 (18.0) 16/31 (34.0) Age (years) 44 [40-54] 53 [44-60] Description of pathology Low-back pain 20 (40) 14 (30) Radicular pain 3 (6) 5 (11) Low-back and radicular pain 27 (54) 28 (60) Failed back surgery syndrome 24 (48) 17 (36) Interval between symptom onset and randomization (weeks) 104 [48-173] 84 [52-264] Characteristic of pain Maximal pain (last 24 ) 7 [6-9] 7 [6-8] Minimal pain (last 24 ) 4 [3-6] 3 [2-5] Current pain 6 [5-7] 4 [3-6] In case of low-back pain At rest (numerical scale) 5 [4-6] 3 [2-6] During movement (numerical scale) 8 [6-9] 6 [5-7] In case of radicular pain At rest (numerical scale) 6 [4-8] 7 [4-8] During movement (numerical scale) 8 [6-9] 7 [6-9] In case of low-back and radicular pain At rest (numerical scale) 6 [4-7] 6 [4-7] During movement (numerical scale) 8 [6-9] 8 [6-9] DN4 ≥ 4 points 19 (38.0) 25 (53.2) EIFEL score 13 [10-17] 14 [11-17] Dallas Pain Questionnaire score 59 [46-70] 52 [42-62] Score for everyday activities 75 [62.25-84] 72 [63-78] Score for professional and leisure activities 70 [49-81] 55 [40-80] Score for anxiety and depression 55 [25-75] 45 [25-65] Score for sociability 40 [20-60] 25 [15-50] Description of treatment At least one analgesic medication per day∗ 45 (90.0) 46 (97.9) Use of class 2 analgesic drug 26 (52.0) 27 (57.4) Non-pharmacological treatment 16 (32.0) 11 (23.4) Professional status Sick leave 17 (34.0) 14 (29.8) Full-time work 22 (44.0) 18 (38.3) Part-time work 8 (16.0) 3 (6.4) Retirement 4 (8.0) 7 (14.9) Results are presented as numbers (percentages) or medians [interquartile ranges]. ∗ This item includes paracetamol, non-steroidal anti-inflammatory drugs, antidepressants, antiepileptic agents, myorelaxant agents, and weak opioid drugs. DN4=neuropathic pain score, TENS=group of patients treated with transcutaneous electrical nerve stimulation, TENS-TEP=group of patients treated with transcutaneous electrical nerve stimulation in combination with a therapeutic education program Garaud et al. Medicine (2018) 97:52 www.md-journal.com 5 0 20 40 60 80 100 Dallas Pain Questionnaire (p = 0.50) 0 5 10 15 20 25 EIFEL score (p = 0.18) Inclusion M1 M3 M6 Inclusion M1 M3 M6 TENS TENS-TEP Figure 2. Evolution of EIFEL score and Dallas Pain Questionnaire, TENS: Group of patients treated with transcutaneous electrical nerve stimulation, TENS-TEP: Group of patients treated with transcutaneous electrical nerve stimulation in combination with a therapeutic education program, PRN: Pain resource nurse, M1, M3, and M6: 1st, 3rd, and 6th month of treatment, respectively. PRN = pain resource nurse. 0 2 4 6 8 10 0 2 4 6 8 10 0 2 4 6 8 10 0 2 4 6 8 10 Rest Movement Inclusion M1 M3 M6 Inclusion M1 M3 M6 Inclusion M1 M3 M6 Inclusion M1 M3 M6 TENS TENS-TEP Lumbar pain Radicular pain p = 0.94 p = 0.52 Rest Movement p = 0.16 p = 0.56 Figure 3. Evolution of pain scores, TENS: Group of patients treated with transcutaneous electrical nerve stimulation, TENS-TEP: Group of patients treated with transcutaneous electrical nerve stimulation in combination with a therapeutic education program, PRN: Pain resource nurse, M1, M3, and M6: 1st, 3rd, and 6th month of treatment, respectively. PRN = pain resource nurse. Garaud et al. Medicine (2018) 97:52 Medicine 6 more than 500 studies and 54,000 patients with a dozen chronic conditions revealed patients' improvement in 58% of studies.[19] Studies of patients with chronic LBP have reported divergent results, namely, favorable effects on certain objective and subjective parameters (Roland-Morris, SOPA-Survey of Pain Attitudes) and on the perception of pain and physical performance,[20] reductions in functional disability and pain with

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