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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274439
• Other study ID #: 02892918.0.0000.8084
• Secondary ID: 2016/24217-7
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2020
• Source: Universidade Cidade de Sao Paulo
• Contact: Iuri Fioratti, PhD Student
• Phone: 55 11 970127143
• Email: iurifioratti[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic pain is a major burden on the individual and society. It is estimated that about one third of the adult population worldwide suffer from chronic pain, with higher prevalence rates reported for low-income countries. Internet-based self-management programs have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic musculoskeletal pain, especially in low and mid-income countries. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 10, 2022
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Rua Cesário Galeno, 448/475	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (19)

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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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Lundell S, Holmner Å, 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. Review. — View Citation

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. — View Citation

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. — View Citation

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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. Epub 2007 Mar 13. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's Expectancy for Improvement at Baseline	Expectancy of Improvement Numerical Scale.	The outcome will be evaluated at the baseline
Primary	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	Pain intensity at 6 months and 12 months follow-up	TMeasured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.	6 months and 12 months follow-up
Secondary	Function	Measured with the Patient Specific Functional Scale, a self-reported scale specific for the measurement of functionality in musculoskeletal injuries, where the patient classifies his activities from 0 to 10, being 0 the inability to perform that function and 10 the total capacity to perform the 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.
Secondary	Health-Related Quality of Life	Measured with the SF-12, a self-reported questionnaire with 12 questions and classification of 8 different dimensions related to quality of life. Higher scores define better 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.
Secondary	Kinesiophobia	Measured with the Tampa Scale of Kinesiophobia, a self-reported questionnaire with 17 questions, where the patient ranks "totally disagree" statements equivalent to one point, "partially disagree", two points, "partially agree", three points and "totally agree", four points . Higher scores at the end of the questionnaire identify worse results in kinesiophobia outcome;	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.
Secondary	Global Perceived Effect	Measured with the Global Perceived Effect Scale, a self-reported scale, with scores of -5 to 5, where the progression of the patient's condition will be classified from a certain point in time. Scores of -5 indicate a lot of worsening and scores of 5 indicate a lot of improvement.	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.
Secondary	Anxiety and Depression	Measured by the Hospital Anxiety and Depression Scale, a self-reported scale with 14 questions, 7 for depression and 7 for anxiety. Each question has a rating ranging from 0 to 3 according to the patient's response. Scores near 21 indicate the worst results.	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.
Secondary	Pain Catastrophisation	Measured with the Pain Catastrophising Scale, a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 being "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.	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.
Secondary	Pain-related Attitudes and Beliefs	Measured with Orebro Musculoskeletal Pain Questionnaire, a self-reported questionnaire with questions related to musculoskeletal pain classified from 0 to 10 and its score calculated later according to these answers and using an own algorithm of the questionnaire.	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.
Secondary	Self-efficacy	Measured with Pain Self-Efficacy Questionnaire, a questionnaire with 22 questions classified in three domains, with a score of each domain ranging from 10 to 100. A total score close to 300 indicates a greater sense of self-efficacy.	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.
Secondary	Adverse Effects	Measured by recording the number of adverse events during the intervention period.	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.