Dataset Information

Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant).

ABSTRACT: INTRODUCTION:Chronic neck pain is a common musculoskeletal disorder that is associated with functional disability and decreased of quality of life. Electrophysical agents are commonly used to relieve pain, however the effects of combined use of these agents are little studied. The objective is to investigate the efficacy of photobiomodulation and electrical stimulation to relieve pain, both in isolation and combined. MATERIALS AND METHODS:This a 4-arm randomized placebo-controlled trial with patient and evaluator blinded. This study will be performed in Department of Physical Therapy at Federal University of São Carlos, São Carlos/SP, Brazil. One hundred and forty-four patients with chronic neck pain will be randomized into 4 groups: active photobiomodulation therapy with active electrical stimulation, active photobiomodulation therapy, active electrical stimulation, or placebo treatment. They will receive 10 sessions of treatment. PRIMARY OUTCOME:pain intensity (measured by pain numerical rating scale) posttreatment. SECONDARY OUTCOMES:pain during movement, neck disability, range of motion, pressure pain threshold, temporal summation, conditioned pain modulation, depressive symptoms, pain catastrophizing, quality of life, analgesic intake, and global perceived effect at posttreatment (10 sessions). Pain intensity and global perceived effect will also be measured after 6 weeks randomization. DISCUSSION:The findings of this study might clarify the importance of using the photobiomodulation therapy and transcutaneous electrical nerve stimulation for patients with chronic neck pain. TRIAL REGISTRATION:NCT04020861. https://clinicaltrials.gov/ct2/show/NCT04020861?term=NCT04020861&draw=2&rank=1.

SUBMITTER: Rampazo EP

PROVIDER: S-EPMC7034724 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant).

Rampazo Érika Patrícia ÉP de Andrade Ana Laura Martins ALM da Silva Viviane Ribeiro VR Back Cláudio Gregório Nuernberg CGN Liebano Richard Eloin RE

Medicine 20200201 8

<h4>Introduction</h4>Chronic neck pain is a common musculoskeletal disorder that is associated with functional disability and decreased of quality of life. Electrophysical agents are commonly used to relieve pain, however the effects of combined use of these agents are little studied. The objective is to investigate the efficacy of photobiomodulation and electrical stimulation to relieve pain, both in isolation and combined.<h4>Materials and methods</h4>This a 4-arm randomized placebo-controlled ...[more]

PMID: 32080103

Similar Datasets

Project description:Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapeutic intervention that is typically used for many years to treat chronic pain in patients who are refractory to pain medications. However, evidence of the efficacy of TENS treatment for neuropathic pain is lacking in humans. To further understand the efficacy of TENS under various intervention conditions and illuminate the current circumstance and future research directions, we systematically reviewed animal studies investigating the efficacy of TENS in relieving pain in neuropathic pain rodent models. We searched the Cochrane Library, EMBASE, MEDLINE (via PubMed), and Web of Science and identified 11 studies. Two meta-analyses were performed. The first meta-analysis showed that a single TENS treatment was capable of temporarily ameliorating neuropathic pain when compared to control groups with a significant effect (standardized mean difference: 1.54; 95% CI: 0.65, 2.42; p = 0.0007; I 2 = 58%). Significant temporary alleviation in neuropathic pain intensity was also observed in the meta-analysis of repetitive TENS (standardized mean difference: 0.85; 95% CI: 0.31, 1.40; p = 0.002; I 2 = 75%). Subgroup analysis showed no effect of the timing of the application of TENS (test for subgroup difference, p = 0.47). Leave-one-out sensitivity analyses suggested that no single study had an outsized effect on the pooled estimates, which may partly prove the robustness of these findings. Other stratified analyses were prevented by the insufficient number of included studies. Overall, current data suggest that TENS might be a promising therapy to ameliorate neuropathic pain. However, the high risk of bias in the included studies suggests that cautions must be considered when interpreting these findings and it is not reasonable to directly generalize the results obtained from animal studies to clinical practice. Future studies should pay more attention to improving the quality of study design and reporting, thereby facilitating the understanding of mechanisms underlying TENS treatment, reducing more potentially unsuccessful clinical trials, and optimizing the efficacy of TENS for people with neuropathic pain.

Project description:ObjectiveFibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.MethodsParticipants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.ResultsAfter 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.ConclusionAmong women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.

Dataset Information

Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant).

Publications

Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets