Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain
NCT ID: NCT04274439
Last Updated: 2020-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2020-03-03
2022-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Internet-Based Pain Education and Exercise
Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis et al (2017), which includes nine main features: (1) acceptance, (2 and 3) education about pain, (4) sleep hygiene, (5) recognizing stress and negative emotions, (6) increasing positive coping in lifestyle, (7) exercises, (8) communication and (9) relapse prevention. The exercise component will include general exercises aiming to improve strength, flexibility, control and coordination.
Patients in this group will also receive weekly text messages and a health coaching over the telephone. The text messages will include information on the benefits of exercises, motivation, and positive messages about dealing with pain.
Internet-Based Pain Education and Exercise
Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.
Online Booklet
The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. They will also receive one phone call at week 4 and text messages once a week during the study period.
Online Booklet
An online booklet containing information about chronic pain and suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.
Interventions
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Internet-Based Pain Education and Exercise
Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.
Online Booklet
An online booklet containing information about chronic pain and suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Seeking treatment for any chronic musculoskeletal pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
* Able to read and understand Portuguese
* With internet access.
* Chronic Pain will be defined as pain lasting more than 12 weeks.
Exclusion Criteria
* Present serious spinal pathologies (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases)
* Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes)
* Recent orthopaedic surgery (over the last 12 months)
* Scheduled to undergo surgery in the next 6 months, or pregnancy
* If have any contraindication to exercise
* We will perform a pre-screening for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version to rule out any contraindication to participate in physical activity.
18 Years
60 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Universidade Cidade de Sao Paulo
OTHER
Responsible Party
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Dr Bruno Saragiotto
Assistant Professor
Principal Investigators
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Bruno T Saragiotto, PostDoc
Role: PRINCIPAL_INVESTIGATOR
Universidade Cidade de Sao Paulo
Locations
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Rua Cesário Galeno, 448/475
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Elzahaf RA, Tashani OA, Unsworth BA, Johnson MI. The prevalence of chronic pain with an analysis of countries with a Human Development Index less than 0.9: a systematic review without meta-analysis. Curr Med Res Opin. 2012 Jul;28(7):1221-9. doi: 10.1185/03007995.2012.703132. Epub 2012 Jul 2.
Fayaz A, Croft P, Langford RM, Donaldson LJ, Jones GT. Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies. BMJ Open. 2016 Jun 20;6(6):e010364. doi: 10.1136/bmjopen-2015-010364.
Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.
Chen B, Li L, Donovan C, Gao Y, Ali G, Jiang Y, Xu T, Shan G, Sun W. Prevalence and characteristics of chronic body pain in China: a national study. Springerplus. 2016 Jun 30;5(1):938. doi: 10.1186/s40064-016-2581-y. eCollection 2016.
Park PW, Dryer RD, Hegeman-Dingle R, Mardekian J, Zlateva G, Wolff GG, Lamerato LE. Cost Burden of Chronic Pain Patients in a Large Integrated Delivery System in the United States. Pain Pract. 2016 Nov;16(8):1001-1011. doi: 10.1111/papr.12357. Epub 2015 Oct 7.
Woby SR, Roach NK, Urmston M, Watson PJ. The relation between cognitive factors and levels of pain and disability in chronic low back pain patients presenting for physiotherapy. Eur J Pain. 2007 Nov;11(8):869-77. doi: 10.1016/j.ejpain.2007.01.005. Epub 2007 Mar 13.
Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the relation between pain-related fear and outcome in chronic low back pain patients. Eur J Pain. 2007 Oct;11(7):711-8. doi: 10.1016/j.ejpain.2006.10.009. Epub 2007 Jan 10.
Foster NE, Thomas E, Bishop A, Dunn KM, Main CJ. Distinctiveness of psychological obstacles to recovery in low back pain patients in primary care. Pain. 2010 Mar;148(3):398-406. doi: 10.1016/j.pain.2009.11.002. Epub 2009 Dec 22.
Truchon M. Determinants of chronic disability related to low back pain: towards an integrative biopsychosocial model. Disabil Rehabil. 2001 Nov 20;23(17):758-67. doi: 10.1080/09638280110061744.
Lotze M, Moseley GL. Theoretical Considerations for Chronic Pain Rehabilitation. Phys Ther. 2015 Sep;95(9):1316-20. doi: 10.2522/ptj.20140581. Epub 2015 Apr 16.
Ballantyne JC, Sullivan MD. Intensity of Chronic Pain--The Wrong Metric? N Engl J Med. 2015 Nov 26;373(22):2098-9. doi: 10.1056/NEJMp1507136. No abstract available.
Dear BF, Titov N, Perry KN, Johnston L, Wootton BM, Terides MD, Rapee RM, Hudson JL. The Pain Course: a randomised controlled trial of a clinician-guided Internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional well-being. Pain. 2013 Jun;154(6):942-50. doi: 10.1016/j.pain.2013.03.005.
Lundell S, Holmner A, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27.
Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):625-638. doi: 10.1177/0269215516645148. Epub 2016 May 2.
Khan F, Amatya B, Kesselring J, Galea MP. Telerehabilitation for persons with multiple sclerosis. A Cochrane review. Eur J Phys Rehabil Med. 2015 Jun;51(3):311-25. Epub 2015 May 6.
de Boer MJ, Versteegen GJ, Vermeulen KM, Sanderman R, Struys MM. A randomized controlled trial of an Internet-based cognitive-behavioural intervention for non-specific chronic pain: an effectiveness and cost-effectiveness study. Eur J Pain. 2014 Nov;18(10):1440-51. doi: 10.1002/ejp.509. Epub 2014 Apr 29.
Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132.
Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
Reis FJJ, Bengaly AGC, Valentim JCP, Santos LC, Martins EF, O'Keeffe M, Meziat-Filho N, Nogueira LC. An E-Pain intervention to spread modern pain education in Brazil. Braz J Phys Ther. 2017 Sep-Oct;21(5):305-306. doi: 10.1016/j.bjpt.2017.06.020. Epub 2017 Aug 19. No abstract available.
Fioratti I, Miyamoto GC, Fandim JV, Ribeiro CPP, Batista GD, Freitas GE, Palomo AS, Reis FJJD, Costa LOP, Maher CG, Saragiotto BT. Feasibility, Usability, and Implementation Context of an Internet-Based Pain Education and Exercise Program for Chronic Musculoskeletal Pain: Pilot Trial of the ReabilitaDOR Program. JMIR Form Res. 2022 Aug 30;6(8):e35743. doi: 10.2196/35743.
Fioratti I, Saragiotto BT, Reis FJJ, Miyamoto GC, Lee H, Yamato TP, Fandim JV, Dear B, Maher CG, Costa LOP. Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation. BMC Musculoskelet Disord. 2020 Jun 26;21(1):404. doi: 10.1186/s12891-020-03423-x.
Other Identifiers
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2016/24217-7
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
02892918.0.0000.8084
Identifier Type: -
Identifier Source: org_study_id
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