Smartphone-based exercise intervention for chronic pain: PainReApp randomized clinical trial protocol.


Journal

Journal of advanced nursing
ISSN: 1365-2648
Titre abrégé: J Adv Nurs
Pays: England
ID NLM: 7609811

Informations de publication

Date de publication:
Feb 2022
Historique:
received: 08 10 2021
accepted: 05 11 2021
pubmed: 27 11 2021
medline: 19 1 2022
entrez: 26 11 2021
Statut: ppublish

Résumé

To evaluate the effectiveness of PainReApp, an mHealth system, based on physical exercise recommendations for patients with chronic pain (low back pain, fibromyalgia and diabetic neuropathic pain) based on pain intensity, quality of life, anxiety and/or depression, and sleep quality. Single-blinded randomized controlled trial. One hundred patients from three different chronic conditions (low back pain, fibromyalgia and neuropathic diabetic pain) will be recruited and randomized into two groups to receive the intervention with a physical activity program guided by the PainReApp system (experimental group) or with the program information in paper format (control group). All patients will attend a first face-to-face session in which the smartphone application usage (experimental group) and exercise execution will be explained (both groups). Data will be collected at baseline, 4, 12 and 24 weeks. Nevertheless, the users of the application will have a daily registry of the exercise performed and the self-perceived difficulty. The primary outcomes of the trial will be the intensity of pain and quality of life. Anxiety and/or depression and sleep quality will be also assessed to evaluate the influence of the physical activity at multiple levels. Physical exercise is becoming one of the leading evidence-based interventions to treat chronic pain. It needs to be adapted to the necessities of each pain condition. One of the major problems is the low adherence to the proposed program. New strategies that empower the patients, such as the m-Health, are reliable and useful tools to ease this end. To the best of our knowledge, this is the first long-term randomized controlled trial researching the impact of an m-health system on chronic pain from different origin. The intervention is based on international physical exercise recommendations and can be performed without specific material, allowing the home-based practice. Australian and New Zealand Clinical Trials Registry (ACTRN12621000783820).

Identifiants

pubmed: 34825739
doi: 10.1111/jan.15095
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

569-576

Subventions

Organisme : Fundación Grünenthal España
Organisme : University of Cádiz
ID : PR2017-038
Organisme : Fundación Española del Dolor (FED)
ID : BF2-19-22
Organisme : The Biomedical Research, and Innovation Institute of Cadiz (INiBICA)
ID : LI19/04IN-CO13

Informations de copyright

© 2021 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.

Références

Allen, R. P., Kosinski, M., Hill-Zabala, C. E., & Calloway, M. O. (2009). Psychometric evaluation and tests of validity of the Medical Outcomes Study 12-item Sleep Scale (MOS sleep). Sleep Medicine, 10(5), 531-539. https://doi.org/10.1016/j.sleep.2008.06.003
Ambrose, K. R., & Golightly, Y. M. (2015). Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Practice & Research Clinical Rheumatology, 29(1), 120-130. https://doi.org/10.1016/j.berh.2015.04.022
American College of Sports Medicine. (2018). ACSM’s guidelines for exercise testing and prescription (10th ed.). Wolters Kluwer.
Bjelland, I., Dahl, A. A., Haug, T. T., & Neckelmann, D. (2002). The validity of the Hospital Anxiety and Depression Scale: An updated literature review. Journal of Psychosomatic Research, 52(2), 69-77. https://doi.org/10.1016/S0022-3999(01)00296-3
Chan, A. W., Tetzlaff, J. M., Gøtzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hróbjartsson, A., Schulz, K. F., Parulekar, W. R., Krleza-Jeric, K., Laupacis, A., & Moher, D. (2013). SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. BMJ, 346, e7586. https://doi.org/10.1136/bmj.e7586
Cohen, S. P., Vase, L., & Hooten, W. M. (2021). Chronic pain: An update on burden, best practices, and new advances. The Lancet, 397(10289), 2082-2097. https://doi.org/10.1016/S0140-6736(21)00393-7
Finan, P. H., & Smith, M. T. (2013). The comorbidity of insomnia, chronic pain, and depression: Dopamine as a putative mechanism. In Sleep Medicine Reviews, 17(3), 173-183. https://doi.org/10.1016/j.smrv.2012.03.003
Gao, & Lee (2019). Emerging technology in promoting physical activity and health: Challenges and opportunities. Journal of Clinical Medicine, 8(11). https://doi.org/10.3390/jcm8111830
Geneen, L., Moore, R., Clarke, C., Martin, D., Colvin, L., & Smith, B. (2017). Physical activity and exercise for chronic pain in adults: An overview of Cochrane Reviews. Cochrane Database of Systematic Reviews, 1, CD011279. https://doi.org/10.1002/14651858.CD011279.pub2.www.cochranelibrary.com
Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011). Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF). Arthritis Care and Research, 63(Suppl. 11), S240-S252. https://doi.org/10.1002/acr.20543
Hayes, C., Bhandari, N., Kathe, N., & Payakachat, N. (2017). Reliability and validity of the medical outcomes study short form-12 version 2 (SF-12v2) in adults with non-cancer pain. Healthcare, , 5(2), 22. https://doi.org/10.3390/healthcare5020022
Iversen, V. M., Vasseljen, O., Mork, P. J., Berthelsen, I. R., Børke, J. B. B., Berheussen, G. F., Tveter, A. T., Salvesen, Ø., & Fimland, M. S. (2017). Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol. Contemporary Clinical Trials Communications, 6, 115-121. https://doi.org/10.1016/j.conctc.2017.04.001
Kristensen, J., & Franklyn-Miller, A. (2012). Resistance training in musculoskeletal rehabilitation: A systematic review. British Journal of Sports Medicine, 46(10), 719-726. https://doi.org/10.1136/bjsm.2010.079376
Lee, J. S., Ahn, S., Lee, K. H., Kim, J. H., Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. Italian Journal of Public Health. https://doi.org/10.4178/epih/e2014029
Lee, P. H., Macfarlane, D. J., Lam, T., & Stewart, S. M. (2011). Validity of the international physical activity questionnaire short form (IPAQ-SF): A systematic review. International Journal of Behavioral Nutrition and Physical Activity, 8(1), 115. https://doi.org/10.1186/1479-5868-8-115
Mayer, J., Mooney, V., & Dagenais, S. (2008). Evidence-informed management of chronic low back pain with lumbar extensor strengthening exercises. The Spine Journal, 8(1), 96-113. https://doi.org/10.1016/j.spinee.2007.09.008
Messier, S. P., Mihalko, S. L., Legault, C., Miller, G. D., Nicklas, B. J., DeVita, P., Beavers, D. P., Hunter, D. J., Lyles, M. F., Eckstein, F., Williamson, J. D., Carr, J. J., Guermazi, A., & Loeser, R. F. (2013). Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: The IDEA randomized clinical trial. JAMA, 310(12), 1263-1273. https://doi.org/10.1001/jama.2013.277669
Moman, R. N., Dvorkin, J., Pollard, E. M., Wanderman, R., Murad, M. H., Warner, D. O., & Hooten, W. M. (2019). A systematic review and meta-analysis of unguided electronic and mobile health technologies for chronic pain-Is it time to start prescribing electronic health applications? Pain Medicine, 20(11), 2238-2255. https://doi.org/10.1093/pm/pnz164
Moral-Munoz, J. A., Zhang, W., Cobo, M. J., Herrera-Viedma, E., & Kaber, D. B. (2019). Smartphone-based systems for physical rehabilitation applications: A systematic review. Assistive Technology, 33(4), 223-236. https://doi.org/10.1080/10400435.2019.1611676
Newman-Beinart, N. A., Norton, S., Dowling, D., Gavriloff, D., Vari, C., Weinman, J. A., & Godfrey, E. L. (2017). The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: The Exercise Adherence Rating Scale (EARS). Physiotherapy, 103(2), 180-185. https://doi.org/10.1016/j.physio.2016.11.001
Okely, A. D., Kontsevaya, A., Ng, J., & Abdeta, C. (2021). 2020 WHO guidelines on physical activity and sedentary behavior. Sports Medicine and Health Science, 3(2), 115-118. https://doi.org/10.1016/j.smhs.2021.05.001
Parker, S. L., Adogwa, O., Mendenhall, S. K., Shau, D. N., Anderson, W. N., Cheng, J. S., Devin, C. J., & McGirt, M. J. (2012). Determination of minimum clinically important difference (MCID) in pain, disability, and quality of life after revision fusion for symptomatic pseudoarthrosis. The Spine Journal, 12(12), 1122-1128. https://doi.org/10.1016/j.spinee.2012.10.006
Pollock, A. S., Durward, B. R., Rowe, P. J., & Paul, J. P. (2000). What is balance? Clinical Rehabilitation, 14(4), 402-406. https://doi.org/10.1191/0269215500cr342oa
Portelli, P., & Eldred, C. (2016). A quality review of smartphone applications for the management of pain. British Journal of Pain, 10(3), 135-140. https://doi.org/10.1177/2049463716638700
Powers, J. R., Goodger, B., & Byles, J. E. (2004). Assessment of the abbreviated Duke Social Support Index in a cohort of older Australian women. Australasian Journal on Ageing, 23(2), 71-76. https://doi.org/10.1111/j.1741-6612.2004.00008.x
Rikli, R. E., & Jones, C. J. (1999). Development and validation of a functional fitness test for community-residing older adults. Journal of Aging and Physical Activity, 7(2), 129-161. https://doi.org/10.1123/japa.7.2.129
Rosser, B., & Eccleston, C. (2011). Smartphone applications for pain management. Journal of Telemedicine and Telecare, 17(6), 308-312. https://doi.org/10.1258/jtt.2011.101102
Salazar, A., de Sola, H., Failde, I., & Moral-Munoz, J. A. (2018). Measuring the quality of mobile apps for the management of pain: Systematic search and evaluation using the mobile app rating scale. JMIR mHealth and uHealth, 6(10), e10718. https://doi.org/10.2196/10718
Slattery, B. W., Haugh, S., O’Connor, L., Francis, K., Dwyer, C. P., O’Higgins, S., Egan, J., & McGuire, B. E. (2019). An evaluation of the effectiveness of the modalities used to deliver electronic health interventions for chronic pain: Systematic review with network meta-analysis. Journal of Medical Internet Research, 21(7), e11086. https://doi.org/10.2196/11086
Stagg, N. J., Mata, H. P., Ibrahim, M. M., Henriksen, E. J., Porreca, F., Vanderah, T. W., & Philip Malan, T. (2011). Regular exercise reverses sensory hypersensitivity in a rat neuropathic pain model. Anesthesiology, 114(4), 940-948. https://doi.org/10.1097/ALN.0b013e318210f880
Steffen, T. M., Hacker, T. A., & Mollinger, L. (2002). Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Physical Therapy. https://doi.org/10.1093/ptj/82.2.128
Steinhubl, S. R., Muse, E. D., & Topol, E. J. (2015). The emerging field of mobile health. Science Translational Medicine, 7(283), 283rv3. https://doi.org/10.1126/scitranslmed.aaa3487
TechNavio. (2020). Global telerehabilitation systems market 2020-2024.
Waddell, G. (1987). 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine, 12(7), 632-644. http://www.ncbi.nlm.nih.gov/pubmed/2961080
Wallace, L. S., & Dhingra, L. K. (2014). A systematic review of smartphone applications for chronic pain available for download in the United States. Journal of Opioid Management, 10(1), 63-68. https://doi.org/10.5055/jom.2014.0193
World Health Organization. (2021). Physical activity. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/physical-activity

Auteurs

Jose A Moral-Munoz (JA)

Biomedical Research and Innovation Institute of Cadiz (INiBICA), Cadiz, Spain.
Observatory of Pain, Grünenthal Foundation-University of Cadiz, Cadiz, Spain.
Department of Nursing and Physiotherapy, University of Cadiz, Cadiz, Spain.

Alejandro Salazar (A)

Biomedical Research and Innovation Institute of Cadiz (INiBICA), Cadiz, Spain.
Observatory of Pain, Grünenthal Foundation-University of Cadiz, Cadiz, Spain.
Department of Statistics and Operational Research, University of Cadiz, Puerto Real, Spain.

María Dueñas (M)

Biomedical Research and Innovation Institute of Cadiz (INiBICA), Cadiz, Spain.
Observatory of Pain, Grünenthal Foundation-University of Cadiz, Cadiz, Spain.
Department of Statistics and Operational Research, University of Cadiz, Puerto Real, Spain.

Helena De Sola (H)

Biomedical Research and Innovation Institute of Cadiz (INiBICA), Cadiz, Spain.
Observatory of Pain, Grünenthal Foundation-University of Cadiz, Cadiz, Spain.
Preventive Medicine and Public Health Area, University of Cadiz, Cadiz, Spain.

Inmaculada Failde (I)

Biomedical Research and Innovation Institute of Cadiz (INiBICA), Cadiz, Spain.
Observatory of Pain, Grünenthal Foundation-University of Cadiz, Cadiz, Spain.
Preventive Medicine and Public Health Area, University of Cadiz, Cadiz, Spain.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH