Study protocol randomised controlled trial comparison of cost-utility and cost-effectiveness of a face-to-face rehabilitation programme versus a telemedicine programme in the treatment of patients with chronic low back pain.

Szczegóły
Abstrakt

Tytuł:: Study protocol randomised controlled trial comparison of cost-utility and cost-effectiveness of a face-to-face rehabilitation programme versus a telemedicine programme in the treatment of patients with chronic low back pain.
Autorzy:: Castro-Sanchez AM; Enfermería, Fisioterapia y Medicina, Universidad de Almeria, Almeria, Spain.
Matarán-Peñarrocha GA; Andalusian Health Service, Family Medicine and Primary Care, Distrito Sanitario Málaga, Málaga, Spain.
Gómez-García S; Clinical Rehabilitation Management Unit, Torrecárdenas University Hospital of Almería, Almería, Spain.
García-López H; Department Physical Therapy, Universidad De Almeria Facultad de Ciencias de la Educacion Enfermeria y Fisioterapia, Almeria, Spain.
Andronis L; Division of Clinical Trials, Warwick Meidical School, University of Warwick, Birmingham and Coventry, UK.
Albornoz-Cabello M; Department of Physiotherapy, University of Seville, Seville, Spain.
Lara Palomo IC; Department Physical Therapy, Universidad De Almeria Facultad de Ciencias de la Educacion Enfermeria y Fisioterapia, Almeria, Spain .
Źródło:: BMJ open [BMJ Open] 2020 Dec 12; Vol. 10 (12), pp. e040633. Date of Electronic Publication: 2020 Dec 12.
Typ publikacji:: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
MeSH Terms:: Chronic Pain*/therapy
Low Back Pain*/therapy
Telemedicine*
Cost-Benefit Analysis ; Europe ; Humans ; Multicenter Studies as Topic ; Quality of Life ; Randomized Controlled Trials as Topic ; Treatment Outcome
References:: JAMA Intern Med. 2016 Feb;176(2):199-208. (PMID: 26752509)
Control Clin Trials. 2001 Jun;22(3):228-37. (PMID: 11384787)
Man Ther. 2012 Jun;17(3):236-40. (PMID: 22342196)
Patient Educ Couns. 2017 Jan;100(1):37-49. (PMID: 27554077)
Spine (Phila Pa 1976). 2002 Mar 15;27(6):596-603. (PMID: 11884907)
Ergonomics. 2000 Jul;43(7):880-902. (PMID: 10929824)
Phys Ther. 1982 Oct;62(10):1431-7. (PMID: 7122701)
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. (PMID: 11124727)
Neuromodulation. 2018 Jan;21(1):1-9. (PMID: 29230905)
Appl Health Econ Health Policy. 2017 Apr;15(2):173-201. (PMID: 27550240)
Value Health. 2018 May;21(5):596-604. (PMID: 29753358)
Medicine (Baltimore). 2017 Sep;96(36):e7991. (PMID: 28885356)
J Physiother. 2017 Apr;63(2):120. (PMID: 28325480)
Surg Technol Int. 2016 Apr;28:296-302. (PMID: 27042787)
Lancet. 2016 Oct 8;388(10053):1545-1602. (PMID: 27733282)
J Spinal Disord. 1992 Dec;5(4):390-6; discussion 397. (PMID: 1490035)
Man Ther. 2003 Feb;8(1):29-36. (PMID: 12586559)
Health Technol Assess. 2009 Jun;13(29):iii, ix-xi, 1-61. (PMID: 19500484)
J Med Internet Res. 2017 May 21;19(5):e179. (PMID: 28550009)
Spine (Phila Pa 1976). 2005 Dec 1;30(23):2657-66. (PMID: 16319752)
Spine J. 2008 Jan-Feb;8(1):1-7. (PMID: 18164448)
Stat Med. 2000 Dec 15;19(23):3219-36. (PMID: 11113956)
J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. (PMID: 22466247)
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. (PMID: 11124729)
Aust J Physiother. 2004;50(4):209-16. (PMID: 15574109)
Cochrane Database Syst Rev. 2016 Jan 08;(1):CD012004. (PMID: 26742533)
Phys Ther. 2009 Jan;89(1):9-25. (PMID: 19056854)
Spine (Phila Pa 1976). 2008 Dec 15;33(26):2923-8. (PMID: 19092626)
J Orthop Sports Phys Ther. 2018 Jun;48(6):476-490. (PMID: 29602304)
Spine (Phila Pa 1976). 2010 Aug 15;35(18):1714-20. (PMID: 21374895)
Reg Anesth Pain Med. 2018 May;43(4):425-433. (PMID: 29394211)
Phys Ther. 2016 Jul;96(7):1039-48. (PMID: 26678446)
J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. (PMID: 1490034)
Spine (Phila Pa 1976). 2000 Apr 15;25(8):989-94. (PMID: 10767813)
Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003008. (PMID: 16034883)
Musculoskelet Sci Pract. 2018 Dec;38:77-82. (PMID: 30317015)
J Med Internet Res. 2015 Feb 24;17(2):e52. (PMID: 25803266)
Med Clin (Barc). 1995 May 27;104(20):771-6. (PMID: 7783470)
Spine (Phila Pa 1976). 2004 Nov 15;29(22):E515-9. (PMID: 15543053)
Value Health. 2008 Sep-Oct;11(5):886-97. (PMID: 18489513)
Health Econ. 2018 Apr;27(4):746-761. (PMID: 29282798)
Spine (Phila Pa 1976). 2011 Oct 1;36(21 Suppl):S19-42. (PMID: 21952188)
BMC Pulm Med. 2016 May 23;16(1):83. (PMID: 27215329)
Eur J Health Econ. 2010 Oct;11(5):513-20. (PMID: 20405159)
Phys Ther. 2016 Oct;96(10):1620-1637. (PMID: 27081203)
Spine J. 2008 Jan-Feb;8(1):8-20. (PMID: 18164449)
Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. (PMID: 23238489)
Spine (Phila Pa 1976). 2006 Apr 20;31(9):E254-62. (PMID: 16641766)
Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. (PMID: 10453772)
Eur J Pain. 2018 Apr;22(4):663-678. (PMID: 29282846)
Spine J. 2013 Dec;13(12):1940-50. (PMID: 24169445)
Spine (Phila Pa 1976). 2004 Dec 1;29(23):2593-602. (PMID: 15564907)
Orthop Clin North Am. 2004 Jan;35(1):57-64. (PMID: 15062718)
Man Ther. 2008 Feb;13(1):75-81. (PMID: 17188547)
BMC Health Serv Res. 2015 Feb 21;15:72. (PMID: 25889230)
J Med Soc N J. 1974 May;71(5):365-7. (PMID: 4545280)
Contributed Indexing:: Keywords: health economics; musculoskeletal disorders; pain management; protocols & guidelines; rehabilitation medicine
Molecular Sequence:: ClinicalTrials.gov NCT04266366
Entry Date(s):: Date Created: 20201214 Date Completed: 20210519 Latest Revision: 20210519
Update Code:: 20240104
PubMed Central ID:: PMC7735081
DOI:: 10.1136/bmjopen-2020-040633
PMID:: 33310802
: Czasopismo naukowe

Full Text Finder

Introduction: Chronic lower back pain is a highly prevalent medical condition in Western countries, which that incurs a considerable social and economic burden. Although prescription exercise at home for chronic pain has become a widely used alternative to reduce healthcare costs, the evidence regarding patient adherence and decreased in costs in European countries is scarce and inconclusive. The objective of this study is to examine the cost-utility and cost-effectiveness in patients with chronic lower back pain treated with the McKenzie Method and electroanalgesia via a telemedicine programme versus a face-to-face programme.
Methods and Analysis: This study reports the protocol for a randomised, two-arm, multicentre, parallel controlled trial. A total of 540 patients with chronic lower back pain (onset time ≥3 months, Roland Morris Disability Questionnaire ≥4) will be recruited in three hospitals in Andalusia. Participants will be assigned to one of two groups (n=270, respectively) to receive electroanalgesia and Mckenzie method exercises through a telemedicine or a face-to-face programme. A total of 24 sessions will be administered three times a week for 8 weeks. Since the study design does not allow participant blinding, the outcome assessor and the statistician will be blinded. Use of helth care resources and costs due to work absenteeism will be captured and analysed. In addition, pain, intensity, fear of movement, quality of life and strength of the core muscle and anteflexion lumbar will be recorded at 2 and 6 months after the start of treatment.
Ethics and Dissemination: Human Research and Local Ethics Committee of the 'Hospital Complex Torrecárdenas of Almeria, University Hospital of Granada and Virgen Macarena de Sevilla Hospital-Andalusian Health Service'. Study ﬁndings will be released to the research, clinical and health service through publication in international journals and conferences.
Trial Registration Number: NCT04266366.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Informacja