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      Does touch massage facilitate recovery after stroke? A study protocol of a randomized controlled trial

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          Abstract

          Background

          Despite high quality stroke care, decreased sensorimotor function, anxiety and pain often remain one year after stroke which can lead to impaired health and dependence, as well as higher healthcare costs. Touch massage (TM) has been proven to decrease anxiety and pain, and improve quality of health in other conditions of reduced health, where reduced anxiety seems to be the most pronounced benefit. Thus there are reasons to believe that TM may also reduce anxiety and pain, and improve quality of life after stroke. Further, several studies indicate that somatosensory stimulation can increase sensorimotor function, and it seems feasible to believe that TM could increase independence after stroke. In this study we will evaluate effects of TM after stroke compared to sham treatment.

          Methods

          This is a prospective randomized open-labelled control trial with blinded evaluation (PROBE-design). Fifty patients with stroke admitted to stroke units will be randomized (1:1) to either a TM intervention or a non-active transcutaneous electrical nerve stimulation (non-TENS) control group. Ten sessions of 30 min treatments (TM or control) will be administered during two weeks. Assessment of status according to the International Classification of Functioning, Disability and Health (ICF), including body function, activity, and participation. Assessment of body function will include anxiety, pain, and stress response (heart rate variability and salivary cortisol), where anxiety is the primary outcome. Activity will be assessed by means of sensorimotor function and disability, and participation by means of health-related quality of life. Assessments will be made at baseline, after one week of treatment, after two weeks of treatment, and finally a follow-up after two months. The trial has been approved by the Regional Ethical Review Board.

          Discussion

          TM seems to decrease anxiety and pain, increase health-related quality of life, and improve sensorimotor functions after stroke, but the field is largely unexplored. Considering the documented pleasant effects of massage in general, absence of reported adverse effects, and potential effects in relation to stroke, it is essential to evaluate effects of TM during the sub-acute phase after stroke. The results of this project will hopefully provide important knowledge for evidence-based care.

          Trial registration

          ClinicalTrials.gov: NTC01883947

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          Most cited references52

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          Emotional processing in anterior cingulate and medial prefrontal cortex.

          Negative emotional stimuli activate a broad network of brain regions, including the medial prefrontal (mPFC) and anterior cingulate (ACC) cortices. An early influential view dichotomized these regions into dorsal-caudal cognitive and ventral-rostral affective subdivisions. In this review, we examine a wealth of recent research on negative emotions in animals and humans, using the example of fear or anxiety, and conclude that, contrary to the traditional dichotomy, both subdivisions make key contributions to emotional processing. Specifically, dorsal-caudal regions of the ACC and mPFC are involved in appraisal and expression of negative emotion, whereas ventral-rostral portions of the ACC and mPFC have a regulatory role with respect to limbic regions involved in generating emotional responses. Moreover, this new framework is broadly consistent with emerging data on other negative and positive emotions. Published by Elsevier Ltd.
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            The validation of visual analogue scales as ratio scale measures for chronic and experimental pain.

            Visual analogue scales (VAS) of sensory intensity and affective magnitude were validated as ratio scale measures for both chronic and experimental pain. Chronic pain patients and healthy volunteers made VAS sensory and affective responses to 6 noxious thermal stimuli (43, 45, 47, 48, 49 and 51 degrees C) applied for 5 sec to the forearm by a contact thermode. Sensory VAS and affective VAS responses to these temperatures yielded power functions with exponents 2.1 and 3.8, respectively; these functions were similar for pain patients and for volunteers. The power functions were predictive of estimated ratios of sensation or affect produced by pairs of standard temperatures (e.g. 47 and 49 degrees C), thereby providing direct evidence for ratio scaling properties of VAS. Vas sensory intensity responses to experimental pain, VAS sensory intensity responses to different levels of chronic pain, and direct temperature (experimental pain) matches to 3 levels of chronic pain were all internally consistent, thereby demonstrating the valid use of VAS for the measurement of and comparison between chronic pain and experimental heat pain.
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              Classification and natural history of clinically identifiable subtypes of cerebral infarction.

              We describe the incidence and natural history of four clinically identifiable subgroups of cerebral infarction in a community-based study of 675 patients with first-ever stroke. Of 543 patients with a cerebral infarct, 92 (17%) had large anterior circulation infarcts with both cortical and subcortical involvement (total anterior circulation infarcts, TACI); 185 (34%) had more restricted and predominantly cortical infarcts (partial anterior circulation infarcts, PACI); 129 (24%) had infarcts clearly associated with the vertebrobasilar arterial territory (posterior circulation infarcts, POCI); and 137 (25%) had infarcts confined to the territory of the deep perforating arteries (lacunar infarcts, LACI). There were striking differences in natural history between the groups. The TACI group had a negligible chance of good functional outcome and mortality was high. More than twice as many deaths were due to the complications of immobility than to direct neurological sequelae of the infarct. Patients in the PACI group were much more likely to have an early recurrent stroke than were patients in other groups. Those in the POCI group were at greater risk of a recurrent stroke later in the first year after the index event but had the best chance of a good functional outcome. Despite the small anatomical size of the infarcts in the LACI group, many patients remained substantially handicapped. The findings have important implications for the planning of stroke treatment trials and suggest that various therapies could be directed specifically at the subgroups.
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                Author and article information

                Contributors
                kristina.lamas@umu.se
                charlotte.hager@umu.se
                lenita.lindgren@umu.se
                per.wester@umu.se
                christine.brulin@umu.se
                Journal
                BMC Complement Altern Med
                BMC Complement Altern Med
                BMC Complementary and Alternative Medicine
                BioMed Central (London )
                1472-6882
                4 February 2016
                4 February 2016
                2015
                : 16
                : 50
                Affiliations
                [ ]Department of Nursing, Umeå University, Umeå, Sweden
                [ ]Department of Community Medicine and Rehabilitation, Umeå University, Umeå, Sweden
                [ ]Department of Public Health and Clinical Medicine, Division of Medicine at Umea University, Umea, Sweden
                Author information
                http://orcid.org/0000-0002-5877-3458
                Article
                1029
                10.1186/s12906-016-1029-9
                4743203
                26846253
                fb6fd47e-3fe9-4702-9687-8a9cec8ab676
                © Lämås et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 9 December 2015
                : 27 January 2016
                Funding
                Funded by: Ekhagastiftelsen
                Award ID: 2013-31
                Award Recipient :
                Funded by: the Swedish Stroke Foundation
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Complementary & Alternative medicine
                Complementary & Alternative medicine

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