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      Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial

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          Abstract

          Background

          Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear.

          Methods

          We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4–12) and long-term (week 4–52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration.

          Results

          241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone.

          Conclusions

          Adding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain, but did enhance satisfaction with care.

          Trial registration

          NCT00269321.

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          Most cited references27

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          Interval estimation for the difference between independent proportions: comparison of eleven methods

          Several existing unconditional methods for setting confidence intervals for the difference between binomial proportions are evaluated. Computationally simpler methods are prone to a variety of aberrations and poor coverage properties. The closely interrelated methods of Mee and Miettinen and Nurminen perform well but require a computer program. Two new approaches which also avoid aberrations are developed and evaluated. A tail area profile likelihood based method produces the best coverage properties, but is difficult to calculate for large denominators. A method combining Wilson score intervals for the two proportions to be compared also performs well, and is readily implemented irrespective of sample size.
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            Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations.

            An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case basis, and are ideally informed by patients and their significant others, clinicians, researchers, statisticians, and representatives of society at large.
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              Assessing health-related quality of life in patients with sciatica.

              This study analyzed health-related quality-of-life measures and other clinical and questionnaire data obtained from the Maine Lumbar Spine Study, a prospective cohort study of persons with low back problems. For persons with sciatica, back pain-specific and general measures of health-related quality-of-life were compared with regard to internal consistency, construct validity, reproducibility, and responsiveness in detecting small changes over a 3-month period. Data were collected from 427 participants with sciatica. Baseline in-person interviews were conducted with surgical and medical patients before treatment and by mail at 3 months. Health-related quality-of-life measures included symptoms (frequency and bothersomeness of pain and sciatica) functional status and well-being (modified back pain-specific Roland scale and Medical Outcomes Study 36-item Short Form Health Survey (SF-36), and disability (bed rest, work loss, and restricted activity days). Internal consistency of measures was high. Reproducibility was moderate, as expected after a 3-month interval. The SF-36 bodily pain item and the modified Roland measure demonstrated the greatest amount of change and were the most highly associated with self-rated improvement. The specific and generic measures changed in the expected direction, except for general health perceptions, which declined slightly. A high correlation between clinical findings or symptoms and the modified Roland measure, SF-36, and disability days indicated a high degree of construct validity. These measures performed well in measuring the health-related quality-of-life of patients with sciatica. The modified Roland and the physical dimension of the SF-36 were the measures most responsive to change over time, suggesting their use in prospective evaluation. Disability day measures, although valuable for assessing the societal impact of dysfunction, were less responsive to changes over this short-term follow-up of 3 months.
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                Author and article information

                Contributors
                schu1385@umn.edu
                evans972@umn.edu
                mmaiers@nwhealth.edu
                kschulz@hhrinstitute.org
                lein0122@umn.edu
                bronf003@umn.edu
                Journal
                Chiropr Man Therap
                Chiropr Man Therap
                Chiropractic & Manual Therapies
                BioMed Central (London )
                2045-709X
                15 May 2019
                15 May 2019
                2019
                : 27
                : 21
                Affiliations
                [1 ]ISNI 0000000419368657, GRID grid.17635.36, University of Minnesota, ; Mayo Building C504, 420 Delaware Street SE, Minneapolis, MN 55455 USA
                [2 ]ISNI 0000 0001 0098 0932, GRID grid.283086.7, Northwestern Health Sciences University, ; 2501 W. 84th Street, Bloomington, MN 55431 USA
                [3 ]Hennepin Healthcare Research Institute, 914 South 8th Street S3.116, Minneapolis, MN 55404 USA
                Author information
                http://orcid.org/0000-0001-6314-9425
                Article
                243
                10.1186/s12998-019-0243-1
                6518769
                31114673
                c69be616-1fc6-4055-9d21-d6beb09882e5
                © The Author(s). 2019

                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
                : 2 November 2018
                : 5 March 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000102, Health Resources and Services Administration;
                Award ID: R18HP01425
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000064, National Center for Complementary and Alternative Medicine;
                Award ID: K01AT008965
                Award Recipient :
                Categories
                Research
                Custom metadata
                © The Author(s) 2019

                Complementary & Alternative medicine
                Complementary & Alternative medicine

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