Intensive spa and exercise therapy program for returning to work for low back pain patients: a randomized controlled trial.
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SUBMITTER: Nguyen C
PROVIDER: S-EPMC5738382 | biostudies-literature | 2017 Dec
REPOSITORIES: biostudies-literature
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Intensive spa and exercise therapy program for returning to work for low back pain patients: a randomized controlled trial.
Nguyen Christelle C Boutron Isabelle I Rein Christopher C Baron Gabriel G Sanchez Katherine K Palazzo Clémence C Dupeyron Arnaud A Tessier Jean-Max JM Coudeyre Emmanuel E Eschalier Bénédicte B Forestier Romain R Roques-Latrille Christian-François CF Attal Ygal Y Lefèvre-Colau Marie-Martine MM Rannou François F Poiraudeau Serge S
Scientific reports 20171220 1
We aimed to determine whether a 5-day intensive inpatient spa and exercise therapy and educational program is more effective than usual care in improving the rate of returning to work at 1 year for patients with subacute and chronic low back pain (LBP) on sick leave for 4 to 24 weeks. We conducted a 12-month randomized controlled trial. LBP patients were assigned to 5-day spa (2 hr/day), exercise (30 min/day) and education (45 min/day) or to usual care. The primary outcome was the percentage of ...[more]
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Project description:PurposeThe objective of this study was to evaluate the effects of an exercise program focusing on muscle stretching and endurance training on the 12-month incidence of low back pain (LBP) in office workers.MethodsA 12-month prospective cluster-randomized controlled trial was conducted in healthy office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance. Healthy office workers (n = 563) were randomly assigned at the cluster level into either intervention (n = 282) or control (n = 281) groups. Participants in the intervention group received an exercise program that included daily stretching exercise and twice-a-week muscle endurance training. Those in the control group received no intervention. The 12-month incidence of LBP was the primary outcome. Secondary outcome were pain intensity, disability level, and quality of life and health status. Analyses were performed using the Cox proportional hazard models.ResultsOver the 12-month follow-up, 8.8% of participants in the intervention group and 19.7% in the control group developed incidence of LBP. Hazard rate ratios showed a protective effect of the exercise program for LBP (HR = 0.37, 95% CI 0.22-0.64) after adjusting for biopsychosocial factors. There was no significant difference in pain intensity, disability, and quality of life and health status between those who reported incidence of LBP in the intervention and control groups.ConclusionAn exercise program consisting of muscle stretching and endurance training is an effective intervention to reduce incident LBP for office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance.
| S-EPMC3960439 | biostudies-literature
Project description:IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.
| S-EPMC7818834 | biostudies-literature
Project description:BackgroundLow back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain.MethodsEligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.DiscussionDespite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible.Trial registrationClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.
| S-EPMC7212581 | biostudies-literature
Project description:BackgroundDespite over 2 decades of research, the ability to prevent work-related low back pain (LBP) and disability remains elusive. Recent research suggests that interventions that are focused at the workplace and incorporate the principals of participatory ergonomics and return-to-work (RTW) coordination can improve RTW and reduce disability following a work-related back injury. Workplace interventions or programs to improve RTW are difficult to design and implement given the various individuals and environments involved, each with their own unique circumstances. Intervention mapping provides a framework for designing and implementing complex interventions or programs. The objective of this study is to design a best evidence RTW program for occupational LBP tailored to the Ontario setting using an intervention mapping approach.MethodsWe used a qualitative synthesis based on the intervention mapping methodology. Best evidence from systematic reviews, practice guidelines and key articles on the prognosis and management of LBP and improving RTW was combined with theoretical models for managing LBP and changing behaviour. This was then systematically operationalized into a RTW program using consensus among experts and stakeholders. The RTW Program was further refined following feedback from nine focus groups with various stakeholders.ResultsA detailed five step RTW program was developed. The key features of the program include; having trained personnel coordinate the RTW process, identifying and ranking barriers and solutions to RTW from the perspective of all important stakeholders, mediating practical solutions at the workplace and, empowering the injured worker in RTW decision-making.ConclusionIntervention mapping provided a useful framework to develop a comprehensive RTW program tailored to the Ontario setting.
| S-EPMC2700788 | biostudies-literature
Project description:BackgroundExercise and education is recommended as first-line treatment by evidence-based, international guidelines for low back pain (LBP). Despite consensus regarding the treatment, there is a gap between guidelines and what is offered to patients. Digital LBP treatments are an emerging way of delivering first-line treatment.ObjectiveThe aim of this study is to evaluate outcomes after participation in a 3-month digitally delivered treatment program for individuals with subacute or chronic LBP.MethodsWe analyzed data from 2593 consecutively recruited participants in a digitally delivered treatment program, available via the national health care system in Sweden. The program consists of video-instructed and progressive adaptable exercises, education through text lessons, and a chat and video function connecting participants with a personal physiotherapist. The primary outcome was mean change and proportion reaching a minimal clinically important change (MCIC) for LBP (2 points or 30% decrease) assessed with the numerical rating scale (average pain during the past week, discrete boxes, 0-10, best to worst). Secondary outcomes were mean change and proportion reaching MCIC (10 points or 30%) in disability, assessed with the Oswestry Disability Index (ODI; 0-100, best to worst) and a question on patient acceptable symptom state (PASS).ResultsThe mean participant age was 63 years, 73.85% (1915/2593) were female, 54.72% (1419/2593) had higher education, 50.56% (1311/2593) were retired, and the mean BMI was 26.5 kg/m2. Participants completed on average 84% of the prescribed exercises and lessons, with an adherence of ≥80% in 69.26% (1796/2593) and ≥90% in 50.13% (1300/2593) of the participants. Mean reduction in pain from baseline to 3 months was 1.7 (95% CI -1.8 to -1.6), corresponding to a 35% relative change. MCIC was reached by 58.50% (1517/2593) of participants. ODI decreased 4 points (95% CI -4.5 to -3.7), and 36.48% (946/2593) reached an MCIC. A change from no to yes in PASS was seen in 30.35% (787/2593) of participants. Multivariable analysis showed positive associations between reaching an MCIC in pain and high baseline pain (odds ratio [OR] 1.9, 95% CI 1.6-2.1), adherence (OR 1.5, 95% CI 1.3-1.8), and motivation (OR 1.2, 95% CI 1.0-1.5), while we found negative associations for wish for surgery (OR 0.6, 95% CI 0.5-0.9) and pain in other joints (OR 0.9, 95% CI 0.7-0.9). We found no associations between sociodemographic characteristics and pain reduction.ConclusionsParticipants in this digitally delivered treatment for LBP had reduced pain at 3-month follow-up, and 58.50% (1517/2593) reported an MCIC in pain. Our findings suggest that digital treatment programs can reduce pain at clinically important levels for people with high adherence to treatment but that those with such severe LBP problems that they wish to undergo surgery may benefit from additional support.Trial registrationClinicalTrials.gov NCT05226156; https://clinicaltrials.gov/ct2/show/NCT05226156.
| S-EPMC9257621 | biostudies-literature
Project description:Authors of meta-analyses concluded that exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low back pain (CLBP), particularly in health-care populations. Similar to health-care settings, community organizations provide wellness and lifestyle modification programs. Different versions of the Young Men's Christian Association (YMCA) Y's Way to a Healthy Back program were offered from 1974 to 2004. Champions of the YMCA program and authors of the pilot study designed a Healthy Back Curriculum to update and reintroduce the program. Objective: The research aim of this randomized pilot trial was to investigate the feasibility of a follow-up larger randomized controlled trial on the program's effectiveness for CLBP. The randomized pilot trial addressed subject recruitment, retention, and subject compliance with protocol. Methods: The pilot trial employed a 2-arm parallel group randomized design. Seventy-eight subjects aged 18 to 64 years with low back pain on at least half the days over the previous 6 months were assigned to either (1) a group stretching exercise arm with 12 weekly classes or (2) a self-care book arm. Results: Sixty participants, 30 in each group, completed the study. Out of the 130 members who accepted invitation, 60% were eligible. Retention rate over the 24-week study in the group stretching exercise arm was 30 out of 43 participants (70%). Participants in the group stretching exercise program attended an average of 5 of the 12 classes (42%). Participants completed baseline and follow-up self-report items with no missing data. Conclusion: The pilot study did not prove to be feasible based on the prespecified benchmarks. We suggest that a larger trial should include changes gleaned from the pilot study.
| S-EPMC6495440 | biostudies-literature
Project description:INTRODUCTION:Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS:The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION:This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001288314.
| S-EPMC6731930 | biostudies-literature
Project description:Chronic low back pain it is one of the most common health problems worldwide. Usually is accompanied by a complex set of symptoms and generates significant direct and indirect socioeconomic and health costs. From a therapeutic point of view, there are a wide variety of methods to address the treatment of this pathology, however, these therapies have not been shown definitive efficacy. To investigate the effect of a mixed treatment with exercise and electrical stimulation versus exercise and kinesio taping in patients with non-specific chronic low back pain. A total of 58 patients participated in this single-blinded randomised clinical trial. Participants were assigned to the exercises- kinesio taping group, or exercises- analgesic current group, both received 12 treatment sessions. Disability, fear of movement, anxiety, depression, sleeps quality, pain, lower limb mechanosensitivity and pressure-pain thresholds were recorded at baseline and after 4 weeks of treatment. The 2 × 2 mixed analysis of covariance test showed statistically significant differences between groups for pain (P = 0.046). Pair-wise comparisons with baseline demonstrated significant differences for both groups in pain (P ≤ 0.001), disability (P ≤ 0.001), pressure-pain thresholds (P ≤ 0.044), lower limb mechanosensitivity, (P ≤ 0.047), anxiety (P ≤ 0.001), depression (P ≤ 0.001) and sleep quality (P ≤ 0.010). Patients with chronic low back pain who received a combined treatment of exercises and kinesio taping or analgesic current showed an improvement in pain, disability, anxiety, depression and sleep pattern. Moreover, exercises combined with electrotherapy produces greater improvements over these variables.Trial registration: NCT02812459.
| S-EPMC9259681 | biostudies-literature
Project description:BackgroundThere is strong, internationally confirmed evidence for the short-term effectiveness of multimodal interdisciplinary specific treatment programs for chronic back pain. However, the verification of long-term sustainability of achieved effects is missing so far. For long-term improvement of pain and functional ability high intervention intensity or high volume seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation, purposefully refined aftercare treatments offer the possibility to intensify positive effects or to increase their sustainability. However, quality assured goal-conscious specific aftercare programs for the rehabilitation of chronic back pain are absent.Methods/designThis study aims to examine the efficacy of a specially developed bio-psycho-social chronic back pain specific aftercare intervention (RÜCKGEWINN) in comparison to the current usual aftercare (IRENA) and a control group that is given an educational booklet addressing pain-conditioned functional ability and back pain episodes. Overall rehabilitation effects as well as predictors for compliance to the aftercare programs are analysed. Therefore, a multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation. Aftercare programs are assessed at ten month follow up after dismissal form rehabilitation.DiscussionSpecial methodological and logistic challenges are to be mastered in this trial, which accrue from the interconnection of aftercare interventions to their residential district and the fact that the proportion of patients who take part in aftercare programs is low. The usability of the aftercare program is based on the transference into the routine care and is also reinforced by developed manuals with structured contents, media and material for organisation assistance as well as training manuals for therapists in the aftercare.
| S-EPMC2996344 | biostudies-literature
Project description:Low back pain is highly prevalent among pregnant women, but evidence of an effective treatment are still lacking. Supervised exercise-either land or water based-has shown benefits for low back pain, but no trial has investigated the evidence of an unsupervised water exercise program on low back pain. We aimed to assess the effect of an unsupervised water exercise program on low back pain intensity and days spent on sick leave among healthy pregnant women.In this randomised, controlled, parallel-group trial, 516 healthy pregnant women were randomly assigned to either unsupervised water exercise twice a week for a period of 12 weeks or standard prenatal care. Healthy pregnant women aged 18 years or older, with a single fetus and between 16-17 gestational weeks were eligible. The primary outcome was low back pain intensity measured by the Low Back Pain Rating scale at 32 weeks. The secondary outcomes were self-reported days spent on sick leave, disability due to low back pain (Roland Morris Disability Questionnaire) and self-rated general health (EQ-5D and EQ-VAS).Low back pain intensity was significantly lower in the water exercise group, with a score of 2.01 (95% CI 1.75-2.26) vs. 2.38 in the control group (95% CI 2.12-2.64) (mean difference = 0.38, 95% CI 0.02-0.74 p = 0.04). No difference was found in the number of days spent on sick leave (median 4 vs. 4, p = 0.83), disability due to low back pain nor self-rated general health. There was a trend towards more women in the water exercise group reporting no low back pain at 32 weeks (21% vs. 14%, p = 0.07).Unsupervised water exercise results in a statistically significant lower intensity of low back pain in healthy pregnant women, but the result was most likely not clinically significant. It did not affect the number of days on sick leave, disability due to low back pain nor self-rated health.ClinicalTrials.gov NCT02354430.
| S-EPMC5587299 | biostudies-literature