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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.
Trials. 2017 Dec 22; 18(1):613.T

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.

Authors+Show Affiliations

Karolinska Institutet, Department of Learning, Informatics, Management and Ethics (LIME), Medical Management Centre, Health Economics and Economic Evaluation Research Group, Tomtebodavägen 18A, 17177, Stockholm, Sweden.Karolinska Institutet, Department of Learning, Informatics, Management and Ethics (LIME), Medical Management Centre, Health Economics and Economic Evaluation Research Group, Tomtebodavägen 18A, 17177, Stockholm, Sweden. Ryggkirurgiskt Centrum Stockholm AB, Sophiahemmets sjukhus, Box 5605, 11485, Stockholm, Sweden.Karolinska Institutet, Department of Learning, Informatics, Management and Ethics (LIME), Stockholm Centre for Healthcare Ethics, Health Outcomes and Economic Evaluation Research Group, Tomtebodavägen 18A, 17177, Stockholm, Sweden. Karolinska Institutet, Department of Public Health Sciences, Equity and Health Policy Research Group, Tomtebodavägen 18A, 17177, Stockholm, Sweden. Stockholm County Council, Health Care Services, Tomtebodavägen 18A, 17177, Stockholm, Sweden.Karolinska Institutet, Department of Learning, Informatics, Management and Ethics (LIME), Medical Management Centre, Tomtebodavägen 18A, 17177, Stockholm, Sweden.Karolinska Institutet, Department of Learning, Informatics, Management and Ethics (LIME), Medical Statistics Unit, Tomtebodavägen 18A, 17177, Stockholm, Sweden.Karolinska Institutet, Department of Learning, Informatics, Management and Ethics (LIME), Medical Management Centre, Health Economics and Economic Evaluation Research Group, Tomtebodavägen 18A, 17177, Stockholm, Sweden. niklas.zethraeus@ki.se.

Pub Type(s)

Clinical Trial Protocol
Comparative Study
Journal Article

Language

eng

PubMed ID

29273083

Citation

Gedin, Filip, et al. "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." Trials, vol. 18, no. 1, 2017, p. 613.
Gedin F, Skeppholm M, Burström K, et al. 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. Trials. 2017;18(1):613.
Gedin, F., Skeppholm, M., Burström, K., Sparring, V., Tessma, M., & Zethraeus, N. (2017). 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. Trials, 18(1), 613. https://doi.org/10.1186/s13063-017-2351-3
Gedin F, et al. 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. Trials. 2017 Dec 22;18(1):613. PubMed PMID: 29273083.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Gedin,Filip, AU - Skeppholm,Martin, AU - Burström,Kristina, AU - Sparring,Vibeke, AU - Tessma,Mesfin, AU - Zethraeus,Niklas, Y1 - 2017/12/22/ PY - 2017/07/09/received PY - 2017/11/20/accepted PY - 2017/12/24/entrez PY - 2017/12/24/pubmed PY - 2019/3/21/medline KW - Chiropractic KW - Chronic low back pain KW - Cost KW - Effectiveness KW - Exercise KW - Manipulation KW - Physiotherapy SP - 613 EP - 613 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29273083/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2351-3 DB - PRIME DP - Unbound Medicine ER -