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      Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial

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          Abstract

          Background

          About 69% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments—some carrying a risk for opioid addiction—highlighting an urgent need for new treatments. In this study, we will test our hypothesis that Spring Forest Qigong™ will reduce SCI-related neuropathic pain by improving body awareness. We will determine whether remotely delivered Qigong is feasible and we will collect data on neuropathic pain, and other reported associations with pain such as spasms frequency and/or severity, functional performance, mood, and body awareness.

          Methods

          In this quasi-experimental pilot clinical trial study, adults with SCI will practice Qigong at home with a 45-min video, at least 3 × /week for 12 weeks. The Qigong practice includes movements with guided breathing and is individualized based on functional abilities, i.e., the participants follow along with the Qigong movements to the level of their ability, with guided breathing, and perform kinesthetic imagery by focusing on the feeling in the whole body as if doing the whole-body Qigong movement while standing. The highest, average, and lowest neuropathic pain ratings perceived in the prior week will be recorded weekly until the 6-week follow-up. The other outcomes will be collected at 5 time points: at baseline, midway during the Qigong intervention (6 weeks), after the Qigong intervention (12 weeks), after a 6-week and 1-year follow-up. Rate parameters for the feasibility markers will be estimated based on the participants who achieved each benchmark.

          Discussion

          The University of Minnesota (UMN)’s Institutional Review Board (IRB) approved the study (IRB #STUDY00011997). All participants will sign electronic informed consent on the secure UMN REDCap platform. The results will be presented at academic conferences and published in peer-reviewed publications.

          Trial registration

          ClinicalTrial.gov registration number: NCT04917107, (this protocol paper refers to the substudy), first registered 6/8/2021.

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          Most cited references61

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          The PHQ-9: validity of a brief depression severity measure.

          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research

            Despite the prevalence of sleep complaints among psychiatric patients, few questionnaires have been specifically designed to measure sleep quality in clinical populations. The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period with "good" sleepers (healthy subjects, n = 52) and "poor" sleepers (depressed patients, n = 54; sleep-disorder patients, n = 62). Acceptable measures of internal homogeneity, consistency (test-retest reliability), and validity were obtained. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers. The clinimetric and clinical properties of the PSQI suggest its utility both in psychiatric clinical practice and research activities.
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              "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician.

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                Author and article information

                Contributors
                avandewi@umn.edu
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                22 August 2023
                22 August 2023
                2023
                : 9
                : 145
                Affiliations
                [1 ]GRID grid.17635.36, ISNI 0000000419368657, Division of Physical Therapy, Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, , University of Minnesota, ; 420 Delaware St SE (MMC 388), Rm 311, Minneapolis, 55455 USA
                [2 ]GRID grid.17635.36, ISNI 0000000419368657, Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, , University of Minnesota, ; Minneapolis, USA
                [3 ]GRID grid.17635.36, ISNI 0000000419368657, Division of Biostatistics, School of Public Health, , University of Minnesota, ; Minneapolis, USA
                [4 ]GRID grid.17635.36, ISNI 0000000419368657, Department of Rehabilitation Medicine, Medical School, , University of Minnesota, ; Minneapolis, USA
                Author information
                http://orcid.org/0000-0001-8400-3177
                http://orcid.org/0000-0003-2398-085X
                http://orcid.org/0000-0002-7933-389X
                http://orcid.org/0000-0002-0003-6084
                http://orcid.org/0000-0002-0272-1763
                http://orcid.org/0000-0002-7426-6341
                Article
                1374
                10.1186/s40814-023-01374-3
                10464017
                37608389
                b3302203-d032-4641-b9b2-ba73aaf91868
                © BioMed Central Ltd., part of Springer Nature 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 16 October 2022
                : 3 August 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100007249, University of Minnesota;
                Award ID: Internal Funding
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100006108, National Center for Advancing Translational Sciences;
                Award ID: UL1TR002494
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2023

                spinal cord injury,neurological pain,spasms,function,qigong,body awareness

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