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Comparative Study
. 2017 Dec 22;18(1):613.
doi: 10.1186/s13063-017-2351-3.

Effectiveness, costs and cost-effectiveness of chiropractic care and physiotherapy compared with information and advice in the treatment of non-specific chronic low back pain: study protocol for a randomised controlled trial

Filip Gedin  1 , Martin Skeppholm  1   2 , Kristina Burström  3   4   5 , Vibeke Sparring  6 , Mesfin Tessma  7 , Niklas Zethraeus  8
Affiliations
Comparative Study

Effectiveness, costs and cost-effectiveness of chiropractic care and physiotherapy compared with information and advice in the treatment of non-specific chronic low back pain: study protocol for a randomised controlled trial

Filip Gedin et al. Trials. .

Abstract

Background: Low back pain is a global public health problem and a leading cause of disability all over the world. The lifetime prevalence of low back pain is 70-80% and a significant proportion of people affected develop chronic low back pain (CLBP). Besides a severe negative impact on people's health and health-related quality of life, CLBP is associated with substantial costs for society. Medical costs for the management of CLBP and costs for production losses due to absenteeism from work are sizeable. Pharmaceuticals, physical activity, manipulation, and multidisciplinary rehabilitation interventions are examples of widely used treatments for CLBP. However, the scientific basis to recommend the use of one treatment over another is limited and more research is needed to study the effects, costs and cost-effectiveness of treatments for CLBP in clinical practice. The aim of the study is to evaluate the effectiveness (back pain-related functional limitation, back pain intensity, general health, health-related quality of life, and working status), costs (medical costs and costs for production losses) and cost-effectiveness of chiropractic care and physiotherapy when added to information and advice in the treatment of patients with non-specific CLBP in Sweden.

Methods/design: This is a pragmatic randomised controlled trial, where participants are recruited through six primary care rehabilitation units (PCRUs) in Stockholm County Council, Sweden. Individuals with non-specific CLBP are individually randomised to one of four treatment groups: 'information and advice'; 'physiotherapy, and information and advice'; 'chiropractic care, and information and advice'; or 'chiropractic care, physiotherapy, and information and advice'. A sample size of 600 participants will be recruited during a period of 33 months. A computer-based questionnaire is used to collect data on back pain-related functional limitation (Oswestry Disability Index), pain intensity (Numeric Rating Scale), general health (self-rated health), health-related quality of life (EQ-5D-3L), and working status (measured as percentage of full-time work). Data will be collected at baseline, and at 3, 6, and 12 months after baseline.

Discussion: The results from our study should be considered when producing evidence-based guidelines and recommendations on which treatment strategies to use for CLBP.

Trial registration: ISRCTN registry, ID: ISRCTN15830360 . Registered prospectively on 2 February 2017.

Keywords: Chiropractic; Chronic low back pain; Cost; Effectiveness; Exercise; Manipulation; Physiotherapy.

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Conflict of interest statement

Ethics approval and consent to participate

The study is prospectively registered in the ISRCTN registry (2017-02-20: ISRCTN15830360) that will be updated if important protocol modifications are made, and is approved by the Regional Ethical Review Board, Stockholm (Dnr: 2016/1318-31-31).

The following PCRUs are included: ‘Haninge Primärvårdsrehabilitering’, ‘Gustavsbergs Primärvårdsrehabilitering’, ‘Vallentuna Primärvårdsrehabilitering’, ‘Rehab Nordost Täby’, ‘Sundbybergskliniken Primärvårdsrehabilitering’, ‘Nacka RehabCentrum’, and ‘Vallentuna Primärvårdsrehabilitering’. Each PCRU has signed a written certificate to assure that it provides sufficient amount of resources for the completion of the trial. Participation in this study will be voluntary and all information related to the study participants will be confidential. All participants in the study will receive care by a licensed health care professional who is quality assured by the National Board of Health and Welfare in Sweden. The treatment strategies evaluated in this study are commonly and regularly used in primary health care. Potential risks of participating in the study are likely to be small, but minor pain and discomfort is usual after chiropractic care and physiotherapy. These symptoms should disappear after about 3 days.

Only members of the research group will have accesses to the data from this trial. Should someone outside the research group want to use the data, an official request has to be approved by the last author (NZ). All data collected through the computer-based questionnaires will be securely stored on servers at Karolinska Institutet, Stockholm, Sweden, and will be stored for 10 years. The researchers have full authority over the collection of data, management, analysis, interpretation of data, writing of the report, and the decision to submit the report for publication. There is no sponsor or funder to influence the collection of data, management, analysis, interpretation of data, writing of the report, or the decision to submit the report for publication.

Consent for publication

Not applicable

Competing interests

The authors MS, KB, VS, MT, and NZ declare no competing interests. FG is employed part-time by the Scandinavian College of Chiropractic.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study trial profile and randomisation
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

References

    1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010. a systematic analysis for the Global Burden of Disease Study 2010. Lancet (London, England) 2012;380(9859):2163–96. doi: 10.1016/S0140-6736(12)61729-2. - DOI - PMC - PubMed
    1. Ekman M, Johnell O, Lidgren L. The economic cost of low back pain in Sweden in 2001. Acta Orthop. 2005;76(2):275–84. doi: 10.1080/00016470510030698. - DOI - PubMed
    1. Hubertsson J, Englund M, Hallgarde U, Lidwall U, Lofvendahl S, Petersson IF. Sick leave patterns in common musculoskeletal disorders—a study of doctor prescribed sick leave. BMC Musculoskelet Disord. 2014;15:176. doi: 10.1186/1471-2474-15-176. - DOI - PMC - PubMed
    1. Andersson GBJ. Epidemiological features of chronic low-back pain. Lancet. 1999;354(9178):581–5. doi: 10.1016/S0140-6736(99)01312-4. - DOI - PubMed
    1. Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379(9814):482–91. doi: 10.1016/S0140-6736(11)60610-7. - DOI - PubMed

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