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      Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study

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          Abstract

          Background

          Low back pain is a very prevalent condition in the population and cupping therapy has been presented as a frequently used non-pharmacological treatment in this population. However, there is a lack of well-designed studies that evaluate the effects of this technique. This protocol describes a placebo-controlled, randomised, double-blind study that aims to evaluate the effect of dry cupping therapy on pain, physical function, trunk range of motion, quality of life and psychological symptoms in individuals with non-specific chronic low back pain.

          Methods and analysis

          Ninety individuals with chronic non-specific low back pain, aged from 18 to 59 years, will be randomised into two groups: intervention group, which will be submitted to dry cupping therapy application with two suctions; and placebo group which will undergo placebo dry cupping therapy. Both applications will occur bilaterally in parallel to the vertebrae from L1 to L5. The application will be performed once a week for 8 weeks. The volunteers will be evaluated before the treatment (T0), immediately after the first intervention (T1), after 4 weeks of intervention (T4) and after 8 weeks of intervention (T8). The primary outcome will be pain intensity, and secondary outcomes will be physical function, lumbar range of motion, patient expectation, overall perception of effect, quality of life and psychological factors.

          Ethics and dissemination

          This protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 3639814). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.

          Trial registration number

          NCT03909672.

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          Most cited references48

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          Non-specific low back pain.

          Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management guidelines endorse triage to identify the rare cases of low back pain that are caused by medically serious pathology, and so require diagnostic work-up or specialist referral, or both. Because non-specific low back pain does not have a known pathoanatomical cause, treatment focuses on reducing pain and its consequences. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable, thus many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. The overuse of imaging, opioids, and surgery remains a widespread problem.
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            The association between smoking and low back pain: a meta-analysis.

            To assess the association between smoking and low back pain with meta-analysis. We conducted a systematic search of the MEDLINE and EMBASE databases until February 2009. Eighty-one studies were reviewed and 40 (27 cross-sectional and 13 cohort) studies were included in the meta-analyses. In cross-sectional studies, current smoking was associated with increased prevalence of low back pain in the past month (pooled odds ratio [OR] 1.30, 95% confidence interval [CI], 1.16-1.45), low back pain in the past 12 months (OR 1.33, 95% CI, 1.26-1.41), seeking care for low back pain (OR 1.49, 95% CI, 1.38-1.60), chronic low back pain (OR 1.79, 95% CI, 1.27-2.50) and disabling low back pain (OR 2.14, 95% CI, 1.11-4.13). Former smokers had a higher prevalence of low back pain compared with never smokers, but a lower prevalence of low back pain than current smokers. In cohort studies, both former (OR 1.32, 95% CI, 0.99-1.77) and current (OR 1.31, 95% CI, 1.11-1.55) smokers had an increased incidence of low back pain compared with never smokers. The association between current smoking and the incidence of low back pain was stronger in adolescents (OR 1.82, 95% CI, 1.42-2.33) than in adults (OR 1.16, 95% CI, 1.02-1.32). Our findings indicate that both current and former smokers have a higher prevalence and incidence of low back pain than never smokers, but the association is fairly modest. The association between current smoking and the incidence of low back pain is stronger in adolescents than in adults. Copyright 2010 Elsevier Inc. All rights reserved.
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              Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best?

              Translation, cross-cultural adaptation, and clinimetric testing of self-report outcome measures. The aims of this investigation were to perform the translation and cross-cultural adaptation of the Patient-Specific Functional Scale (PSFS) into Brazilian-Portuguese and to perform a head-to-head comparison of the clinimetric properties of the Brazilian-Portuguese versions of the PSFS, the Roland-Morris Disability Questionnaire (RMDQ) and the Functional Rating Index (FRI). To date, there is no Brazilian-Portuguese version of the PSFS available and no head-to-head comparison of the Brazilian-Portuguese versions of the PSFS, RMDQ, and FRI has been undertaken. The PSFS was translated and adapted into Brazilian-Portuguese. The PSFS, the RMDQ, and the FRI were administered to 99 patients with low back pain to evaluate internal consistency, reproducibility, ceiling and floor effects, construct validity, internal and external responsiveness. To fully test the construct validity and external responsiveness of these measures, it was necessary to cross-culturally adapt the Pain Numerical Rating Scale and the Global Perceived Effect Scale. All measures demonstrated high levels of internal consistency (Cronbach's alpha range = 0.88-0.90) and reproducibility (Intraclass Correlation Coefficient 2,1 range = 0.85-0.94). High correlations among the disability-related measures were observed (Pearson's r ranging from 0.51 to 0.71). No ceiling or floor effects were detected. The PSFS was consistently more responsive than the other measures in both the internal responsiveness and external responsiveness analyses. The results from this study demonstrate that the Brazilian-Portuguese versions of the RMDQ, the FRI and the PSFS have similar clinimetric properties to each other and to the original English versions. Of allthe measures tested in this study the PSFS seems the most responsive. These measures will enable international comparisons to be performed, and encourage researchers to include Portuguese speakers in their clinical trials.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                22 December 2019
                : 9
                : 12
                : e032416
                Affiliations
                [1 ] departmentPostgraduate Program in Rehabilitation Sciences , Universidade Federal do Rio Grande do Norte, Faculdade de Ciências da Saúde do Trairi , Santa Cruz, Rio Grande do Norte, Brazil
                [2 ] departmentMaster’s and Doctoral Programs in Physical Therapy , Universidade Cidade de Sao Paulo , Sao Paulo, Brazil
                Author notes
                [Correspondence to ] Marcelo Cardoso de Souza; marcelocardoso@ 123456facisa.ufrn.br
                Author information
                https://orcid.org/0000-0003-2185-4059
                http://orcid.org/0000-0003-4409-8057
                https://orcid.org/0000-0002-7973-188X
                https://orcid.org/0000-0001-6424-3114
                http://orcid.org/0000-0002-9268-8353
                Article
                bmjopen-2019-032416
                10.1136/bmjopen-2019-032416
                6937004
                31871257
                e10f7a3b-d82b-4d64-a69e-58214a3cb55a
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 01 July 2019
                : 07 November 2019
                : 28 November 2019
                Categories
                Rehabilitation Medicine
                Protocol
                1506
                1727
                Custom metadata
                unlocked

                Medicine
                traditional chinese medicine,cupping therapy,chronic pain
                Medicine
                traditional chinese medicine, cupping therapy, chronic pain

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