Dataset Information

Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

ABSTRACT: INTRODUCTION:Low back pain (LBP) is one of the largest and most frequent public health problems worldwide. Photobiomodulation therapy (PBMT) is a frequently used non-pharmacological therapy for the treatment of musculoskeletal disorders. However, there is little high-quality scientific evidence that demonstrates the effectiveness of PBMT in the treatment of patients with chronic LBP in the short, medium and long term. Therefore, the objective of this clinical trial is to evaluate the effects of PBMT in patients with chronic non-specific LBP in the short, medium and long term. METHODS AND ANALYSES:This is a prospectively registered, two-arm randomised placebo-controlled trial with blinded patients, assessors and treatment providers. One hundred and forty-eight patients with chronic non-specific LBP will be recruited. Treatment sessions will be provided three times a week for 4 weeks (totaling 12 sessions) with patients receiving either placebo or active PBMT. For ethical reasons, all patients, regardless of treatment allocation, will also receive an information booklet based on 'The Back Book'. Clinical outcomes will be measured at baseline, at the end of treatment, as well as 3, 6 and 12 months after randomisation. The primary outcomes will be pain intensity and disability measured after 12 sessions of treatment. The secondary outcomes will be pain intensity and disability measured at 3, 6 and 12 months after randomisation, in addition to specific disability and global perceived effect in all time points. ETHICS AND DISSEMINATION:The study was approved by the Research Ethics Committee of Universidade Cidade de São Paulo. The results will be disseminated through scientific publications and presentations at national and international scientific meetings. TRIAL REGISTRATION NUMBER:NCT03089424.

SUBMITTER: Tomazoni SS

PROVIDER: S-EPMC5665327 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

Tomazoni Shaiane Silva SS Costa Lucíola da Cunha Menezes LDCM Guimarães Layana de Souza LS Araujo Amanda Costa AC Nascimento Dafne Port DP Medeiros Flávia Cordeiro de FC Avanzi Marina Athayde MA Costa Leonardo Oliveira Pena LOP

BMJ open 20171024 10

<h4>Introduction</h4>Low back pain (LBP) is one of the largest and most frequent public health problems worldwide. Photobiomodulation therapy (PBMT) is a frequently used non-pharmacological therapy for the treatment of musculoskeletal disorders. However, there is little high-quality scientific evidence that demonstrates the effectiveness of PBMT in the treatment of patients with chronic LBP in the short, medium and long term. Therefore, the objective of this clinical trial is to evaluate the eff ...[more]

PMID: 29070637

Similar Datasets

Project description:Sensorimotor training (SMT) is popularly applied as a preventive or rehabilitative exercise method in various sports and rehabilitation settings. Yet, there is only low-quality evidence on its effect on pain and function. This randomised controlled trial will investigate the effects of a theory-based SMT in rehabilitation of chronic (>3 months) non-specific low back pain (CNLBP) patients.A pilot study with a parallel, single-blinded, randomised controlled design. Twenty adult patients referred to the clinic for CNLBP treatment will be included, randomised, and allocated to one of two groups. Each group will receive 9 x 30 minutes of standard physiotherapy (PT) treatment. The experimental group will receive an added 15 minutes of SMT. For SMT, proprioceptive postural exercises are performed on a labile platform with adjustable oscillation to provoke training effects on different entry levels. The active comparator group will perform 15 minutes of added sub-effective low-intensity endurance training. Outcomes are assessed on 4 time-points by a treatment blinded tester: eligibility assessment at baseline (BL) 2-4 days prior to intervention, pre-intervention assessment (T0), post-intervention assessment (T1), and at 4 weeks follow-up (FU). At BL, an additional healthy control group (n?=?20) will be assessed to allow cross-sectional comparison with symptom-free participants. The main outcomes are self-reported pain (Visual Analogue Scale) and functional status (Oswestry Disability Index). For secondary analysis, postural control variables after an externally perturbed stance on a labile platform are analysed using a video-based marker tracking system and a pressure plate (sagittal joint-angle variability and centre of pressure confidence ellipse). Proprioception is measured as relative cervical joint repositioning error during a head-rotation task. Effect sizes and mixed-model MANOVA (2 groups?×?4 measurements for 5 dependent variables) will be calculated.This is the first attempt to systematically investigate effects of a theory-based sensorimotor training in patients with CNLBP. It will provide analysis of several postural segments during a dynamic task for quantitative analysis of quality and change of the task performance in relation to changes in pain and functional status.Trial registry number on cliniclatrials.gov is NCT02304120 , first registered on 17 November 2014.

Project description:IntroductionChronic low back pain (CLBP) is a highly prevalent and disabling condition. Identifying subgroups of patients afflicted with CLBP is a current research priority, for which a classification system based on pain mechanisms was proposed. Spinal manipulative therapy (SMT) is recommended for the management of CLBP. Yet, little data are available regarding its mechanisms of action, making it difficult to match this intervention to the patients who may benefit the most. It was suggested that SMT may influence mechanisms associated with central sensitisation. Therefore, classifying patients with CLBP according to central sensitisation mechanisms may help predict their response to SMT.Methods and analysisThis protocol describes a randomised placebo-controlled trial aiming to examine which variables linked to central sensitisation may help predict the clinical response to SMT in a cohort of patients with CLBP. One hundred patients with chronic primary low back pain will be randomised to receive 12 sessions of SMT or placebo SMT over a 4-week period. Pain intensity and disability will be assessed as primary outcomes after completing the 4-week treatment (primary endpoint), and at 4-week and 12-week follow-ups. Baseline values of two pain questionnaires, lumbar pressure pain thresholds, concentrations of an inflammatory cytokine and expectations of pain relief will be entered as predictors of the response to SMT in a multiple regression model. Changes in these variables after treatment will be used in a second multiple regression model. The reference values of these predictors will be measured from 50 age and sex-matched healthy controls to allow interpretation of values in patients. Mixed analyses of variance will also be conducted to compare the primary outcomes and the predictors between groups (SMT vs placebo) over time (baseline vs post-treatment).Ethics and disseminationEthical approval was granted by the Fundación Jiménez Díaz Clinical Research Ethics Committee.Trial registration numberNCT05162924.

Project description:IntroductionLow back pain (LBP) is one of the most highly prevalent pain both in developed countries and low-income and middle-income countries. Despite increasing healthcare resources and numerous treatment methods for LBP, the efficacy of these therapeutic strategies is still uncertain. Recently, core stability exercise (CSE) is popularly applied as a preventive or rehabilitative method in the treatment of LBP. However, the adequate activation of the local muscle systems of CSE needs further optimisation and quantification. This trial aims to investigate the feasibility and efficacy of CSE monitored by real-time ultrasound image (RUSI) on LBP individuals.Methods and analysisForty subjects with chronic non-specific LBP (CNLBP), aged from 20 to 50 years, will be randomly allocated into two groups using sealed, consecutively numbered opaque envelopes: (1) study group (SG): CSE monitored by RUSI and (2) control group (CG): identical CSE without monitoring. Interventions will last 30 mins, two times a week for 8 weeks. The primary outcomes include pain intensity, disability and quality of life, and the secondary outcomes will be the postural control static stability, onset timing of trunk muscles activation, ultrasound images of muscle thickness and surface electromyography (sEMG) signal of muscle activities. Outcome measures will be collected at baseline, 4 and 8 weeks during training, and at 6 months follow-up. Data will be collected and analysed by an assessor blinded to group allocation. Effect sizes and mixed-model repeated measures analysis of variance (2 groups×4 time points) will be calculated.Ethics and disseminationThis protocol and informed consent has been approved by the Institutional Research Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University (Approval number: [2020] 254-1). The findings of this study will be disseminated to participants through social networks and will be submitted to peer-reviewed journals and scientific conferences.Trial registration numberChinese Clinical Trial Registry (ChiCTR2000034498).

Dataset Information

Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

Publications

Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets