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Immediate changes in electroencephalography activity in individuals with nonspecific chronic low back pain after cranial osteopathic manipulative treatment: study protocol of a randomized, controlled crossover trial.

ABSTRACT: Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue mobility/ motility dysfunctions in general, using different approaches (depending on the target tissue) known as osteopathic manipulative treatment. Among the available techniques those ones addressed to the cranial field are the most questioned because of the lack of scientific evidence; but the compression of the 4th ventricle technique has been largely studied in clinical trials. Studies have shown that the technique may affect both central and autonomous nervous system, modulating some reflexes (Traube-Hering baro signal), and modifying brain cortex electrical activity through central sensitization in subjects with chronic low back pain. Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak alpha frequency (eletroencephalographic assessment) and promote physical relaxation in subjects in vigil.A randomized, controlled crossover trial with blinded assessor was designed to test the hypothesis. A total of 81 participants will be assigned to three treatment conditions, with seven days of washout: (I) compression of the 4th ventricle; (II) sham compression of the fourth ventricle; (III) control (no intervention). The (I) power amplitude and the (II) frequencies of the dominant peak in the alpha band will be the primary outcome measures of the study. All participants will be recruited at the Outpatient Rehabilitation Service of the University Hospital of Brasília-University of Brasília. All the electroencephalographic exams will be conducted by a blinded assessor.The investigators hypothesize that patients with chronic low back pain submitted to the technique would have the peak alpha frequency modulated and, thus, would experience physical relaxation.NCT02111382.

SUBMITTER: Martins WR

PROVIDER: S-EPMC4499448 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Immediate changes in electroencephalography activity in individuals with nonspecific chronic low back pain after cranial osteopathic manipulative treatment: study protocol of a randomized, controlled crossover trial.

Martins Wagner Rodrigues WR Diniz Leonardo Rios LR Blasczyk Juscelino Castro JC Lagoa Karina Ferreira KF Thomaz Sérgio S Rodrigues Marcia Elisabeth ME de Oliveira Ricardo Jacó RJ Bonini-Rocha Ana Clara AC

BMC complementary and alternative medicine 20150713

<h4>Background</h4>Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue mobility/ motility dysfunctions in general, using different approaches (depending on the target tissue) known as osteopathic manipulative treatment. Among the available techniques those ones addressed to the cranial field are the most questioned because of the lack of scientific evidence; but the compression of the 4th ventricle technique has been largely studied in clinical trials. Studies ha ...[more]

PMID: 26165865

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Project description:Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 - -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Project description:BACKGROUND:According to the American Physical Therapy Association, there is strong evidence to show that vertebral mobilization and manipulation procedures can be used to improve spinal and hip mobility and reduce pain and incapacity in low back pain patients that fit the clinical prediction rule. OBJECTIVES:To evaluate the immediate effects of high-velocity low-amplitude (HVLA) manipulation on pain and postural control parameters in individuals with nonspecific low back pain. METHODS:This study used a participant-blinded and assessor-blinded randomized controlled clinical trial involving a single session, in which 24 participants were randomly distributed into control (simulated manipulation) and intervention (HVLA lumbar manipulation) groups. The primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity) were evaluated before and after the session using a numerical pain scale, algometer, and a force platform. For all outcomes, multiple mixed 2 (group) × 2 (time) ANOVAs were performed. RESULTS:For the subjective pain intensity, only time was significant as a main effect, where pre-intervention presented a greater value then post-intervention (F [1.44]?=?4.377; p =?0.042; r =?0.30). For the pressure pain threshold no significant effect was found. For the postural control parameters, as a main effect, only the ellipse area was significantly greater in the control group (F [1.44]?=?6.760; p =?0.013; effect size?=?0.36). CONCLUSIONS:There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure. No effect of HVLA lumbar manipulation was identified for postural control variables in either the intervention or control groups. TRIAL REGISTRATION:The study was registered at ClinicalTrials.gov under the number NCT02312778, registered at 14 September 2014.

Project description:BackgroundCurrent evidence suggests that spinal manipulative therapy (SMT) is effective in the treatment of people with low back pain (LBP); however, the corresponding mechanisms are unknown. Hypoalgesia is associated with SMT and is suggestive of specific mechanisms.ObjectiveThe primary purpose of this study was to assess the immediate effects of SMT on thermal pain perception in people with LBP. A secondary purpose was to determine whether the resulting hypoalgesia was a local effect and whether psychological influences were associated with changes in pain perception.DesignThis study was a randomized controlled trial.SettingA sample of convenience was recruited from community and outpatient clinics.ParticipantsThirty-six people (10 men, 26 women) currently experiencing LBP participated in the study. The average age of the participants was 32.39 (SD=12.63) years, and the average duration of LBP was 221.79 (SD=365.37) weeks.Intervention and measurementsBaseline demographic and psychological measurements were obtained, followed by quantitative sensory testing to assess temporal summation and Adelta fiber-mediated pain perception. Next, participants were randomly assigned to ride a stationary bicycle, perform low back extension exercises, or receive SMT. Finally, the same quantitative sensory testing protocol was reassessed to determine the immediate effects of each intervention on thermal pain sensitivity.ResultsHypoalgesia to Adelta fiber-mediated pain perception was not observed. Group-dependent hypoalgesia of temporal summation specific to the lumbar innervated region was observed. Pair-wise comparisons indicated significant hypoalgesia in participants who received SMT, but not in those who rode a stationary bicycle or performed low back extension exercises. Psychological factors did not significantly correlate with changes in temporal summation in participants who received SMT.LimitationsOnly immediate effects of SMT were measured, so the authors are unable to comment on whether the inhibition of temporal summation is a lasting effect. Furthermore, the authors are unable to comment on the relationship between their findings and changes in clinical pain.ConclusionsInhibition of Adelta fiber-mediated pain perception was similar for all groups. However, inhibition of temporal summation was observed only in participants receiving SMT, suggesting a modulation of dorsal horn excitability that was observed primarily in the lumbar innervated area.

Project description:BackgroundRecent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms.Methods/designA three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique.DiscussionThe present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol.Trial registrationThe protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.

Dataset Information

Immediate changes in electroencephalography activity in individuals with nonspecific chronic low back pain after cranial osteopathic manipulative treatment: study protocol of a randomized, controlled crossover trial.

Publications

Immediate changes in electroencephalography activity in individuals with nonspecific chronic low back pain after cranial osteopathic manipulative treatment: study protocol of a randomized, controlled crossover trial.

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