Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain

NCT04274439 | Unknown

• 2 other identifiers: 02892918.0.0000.80842016/24217-7
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

Conditions

Chronic Pain

Keywords

Chronic Pain; Telerehabilitation; Telemedicine; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Pain Intensity at post-treatment follow-up

  The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.

  Post-treatment follow-up (8 weeks)

Secondary Outcomes (10)

• Pain intensity at 6 months and 12 months follow-up

  6 months and 12 months follow-up

• Function

  The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.

• Health-Related Quality of Life

  The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.

• Kinesiophobia

  The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.

• Global Perceived Effect

  The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.

Other Outcomes (1)

• Patient's Expectancy for Improvement at Baseline

  The outcome will be evaluated at the baseline

Study Arms (2)

Internet-Based Pain Education and Exercise

EXPERIMENTAL

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.

Other: Internet-Based Pain Education and Exercise

Online Booklet

ACTIVE COMPARATOR

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.

Other: Online Booklet

Interventions

Internet-Based Pain Education and Exercise OTHER

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.

Also known as: Telerehabilitation

Internet-Based Pain Education and Exercise

Online Booklet OTHER

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.

Online Booklet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60 years
• 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.

You may not qualify if:

• Present neurological symptoms (nerve root compromise, or sensation deficits)
• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Rua Cesário Galeno, 448/475

São Paulo, 03071-000, Brazil

RECRUITING

Related Publications (21)

• 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.

  PMID: 22697274 BACKGROUND

• 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.

  PMID: 27324708 BACKGROUND

• 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.

  PMID: 26063472 BACKGROUND

• 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.

  PMID: 27386382 BACKGROUND

• 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.

  PMID: 26443292 BACKGROUND

• 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.

  PMID: 17360202 BACKGROUND

• 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.

  PMID: 17218132 BACKGROUND

• 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.

  PMID: 20022697 BACKGROUND

• 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.

  PMID: 11762878 BACKGROUND

• 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.

  PMID: 25882484 BACKGROUND

• 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.

  PMID: 26605926 BACKGROUND

• 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.

  PMID: 23688830 BACKGROUND

• 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.

  PMID: 25464906 BACKGROUND

• 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.

  PMID: 27141087 BACKGROUND

• 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.

  PMID: 25943744 BACKGROUND

• 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.

  PMID: 24777973 BACKGROUND

• 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.

  PMID: 22665835 BACKGROUND

• 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.

  PMID: 18923324 BACKGROUND

• 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.

  PMID: 28864352 BACKGROUND

• 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.

  PMID: 35776863 DERIVED

• 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.

  PMID: 32590959 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise; Telerehabilitation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Bruno T Saragiotto, PostDoc

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iuri Fioratti, PhD Student

CONTACT

55 11 970127143; iurifioratti@gmail.com

Bruno T Saragiotto, PostDoc

CONTACT

55 11 999105890; bruno.saragiotto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a controlled clinical trial, with the Intervention group performing the 8-week follow-up and access to 8 pain education videos and 8 exercise videos prescribed for patients with chronic pain, and the control group receiving information on chronic pain for one booklet. Randomized through site programming, so that the subject enters his / her login and password and is directed to one of the study groups, with blind evaluator without access to randomization information throughout the course of the study and follow-up of the outcome measures for 3 , 6 and 12 months after randomization.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: February 18, 2020
• Study Start: March 3, 2020
• Primary Completion: September 2, 2021
• Study Completion: March 10, 2022
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)