Non-inferiority of digitally assisted outpatient rehabilitation in patients with back pain: 12-month follow-up of a randomized controlled trial
DOI:
https://doi.org/10.2340/jrm.v58.44366Keywords:
telerehabilitation, digital health, telemedicine, back pain, randomized controlled trialAbstract
Objective: To examine the non-inferiority of digitally assisted, multimodal rehabilitation that utilizes a digital version of a standardized back school (intervention group) compared with a rehabilitation program applying the back school conventionally in person (control group).
Design: Nonblinded, randomized, controlled, non-inferiority trial with 12-month follow-up after the end of rehabilitation.
Subjects/Patients: Adults aged 18–65 years with back pain.
Methods: The back school was part of a 3-week rehabilitation program along with other treatments in accordance with the therapy standards. Eight outpatient rehabilitation centers conducted the rehabilitation program. Self-reported pain self-efficacy (10–60 points) was the primary outcome. Non-inferiority was established if the lower limit of the one-sided 95% confidence interval was greater than –4 points for pain self-efficacy.
Results: A total of 157 participants (55.3%) completed the 12-month follow-up. Multiple imputation of missing data allowed for inclusion of 270 participants in the analysis (intervention group: n = 127, control group: n = 143). Our primary adjusted intention-
to-treat analysis demonstrated that digitally assisted rehabilitation was non-inferior to conventional rehabilitation at the 12-month follow-up (b = 0.48; 95% CI = –3.09 to ∞).
Conclusion: This study supports the hypothesis that digitally assisted rehabilitation is a viable alternative to in-person rehabilitation for patients with back pain.
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References
Von der Lippe E, Krause L, Porst M, Wengler A, Leddin J, Müller A, et al. Prävalenz von Rücken- und Nackenschmerzen in Deutschland. Ergebnisse der Krankheitslast-Studie BURDEN 2020 J Health Monit 2021; 6: 1–14.
Chen S, Chen M, Wu X, Lin S, Tao C, Cao H, et al. Global, regional and national burden of low back pain 1990–2019: a systematic analysis of the Global Burden of Disease study 2019. J Orthop Translat 2022; 32: 49–58. DOI: https://doi.org/10.1016/j.jot.2021.07.005
Wenig CM, Schmidt CO, Kohlmann T, Schweikert B. Costs of back pain in Germany. Eur J Pain 2009; 13: 280–286. DOI: https://doi.org/10.1016/j.ejpain.2008.04.005
Dorner TE, Alexanderson K, Svedberg P, Ropponen A, Stein KV, Mittendorfer-Rutz E. Sickness absence due to back pain or depressive episode and the risk of all-cause and diagnosis-specific disability pension: a Swedish cohort study of 4,823,069 individuals. Eur J Pain 2015; 19: 1308–1320. DOI: https://doi.org/10.1002/ejp.661
Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ 2015; 350: h444. DOI: https://doi.org/10.1136/bmj.h444
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, et al. What low back pain is and why we need to pay attention. Lancet 2018; 391: 2356–2367. DOI: https://doi.org/10.1016/S0140-6736(18)30480-X
Nicol V, Verdaguer C, Daste C, Bisseriex H, Lapeyre E, Lefevre-Colau MM, et al. Chronic low back pain: a narrative review of recent international guidelines for diagnosis and conservative treatment. J Clin Med 2023; 12. DOI: https://doi.org/10.3390/jcm12041685
Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften. Nicht-spezifischer Kreuzschmerz. Patientenleitlinie zur Nationalen VersorgungsLeitlinie 2017 [accessed Nov 27, 2023]. Available from: https://www.register.awmf.org/de/leitlinien/detail/nvl-007
Hawley-Hague H, Lasrado R, Martinez E, Stanmore E, Tyson S. A scoping review of the feasibility, acceptability, and effects of physiotherapy delivered remotely. Disabil Rehabil 2022; 45: 3961–3977. DOI: https://doi.org/10.1080/09638288.2022.2138574
Toelle TR, Utpadel-Fischler DA, Haas KK, Priebe JA. App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: a randomized controlled trial. NPJ Digit Med 2019; 2: 34. DOI: https://doi.org/10.1038/s41746-019-0109-x
Cui D, Janela D, Costa F, Molinos M, Areias AC, Moulder RG, et al. Randomized-controlled trial assessing a digital care program versus conventional physiotherapy for chronic low back pain. NPJ Digit Med 2023; 6: 121. DOI: https://doi.org/10.1038/s41746-023-00870-3
Norrie J. The importance of long-term follow-up in clinical trials. Lancet Glob Health 2023; 11: e995–e996. DOI: https://doi.org/10.1016/S2214-109X(23)00244-9
Bonekamp NE, Visseren FLJ, Cramer MJ, Dorresteijn JAN, van der Meer MG, Ruigrok YM, et al. Long-term lifestyle change and risk of mortality and type 2 diabetes in patients with cardiovascular disease. Eur J Prev Cardiol 2024; 31: 205–213. DOI: https://doi.org/10.1093/eurjpc/zwad316
Meng K, Seekatz B, Roßband H, Worringen U, Vogel H, Faller H. Intermediate and long-term effects of a standardized back school for inpatient orthopedic rehabilitation on illness knowledge and self-management behaviors: a randomized controlled trial. Clin J Pain 2011; 27: 248–257. DOI: https://doi.org/10.1097/AJP.0b013e3181ffbfaf
Hoppe K, Oehme J, Worringen U. Curriculum Rückenschule. Standardisierte Patientenschulung. Berlin: DRV; 2019.
Deutsche Rentenversicherung. Reha-Therapiestandards Chronischer Rückenschmerz. Berlin: DRV; 2020.
Albers R, Lemke S, Fauser D, Knapp S, Krischak G, Bethge M. Non-inferiority of hybrid outpatient telerehabilitation: 3-month follow-up of a randomized controlled trial. Eur J Phys Rehabil Med 2024: 1009–1018. DOI: https://doi.org/10.23736/S1973-9087.24.08458-2
Albers R, Lemke S, Knapp S, Krischak G, Bethge M. Non-inferiority of a hybrid outpatient rehabilitation: a randomized controlled trial (HIRE, DRKS00028770). BMC Digit Health 2023; 1: 1–13. DOI: https://doi.org/10.1186/s44247-023-00013-4
Wellek S, Blettner M. Establishing equivalence or non-inferiority in clinical trials: part 20 of a series on evaluation of scientific publications. Dtsch Arztebl Int 2012; 109: 674–679. DOI: https://doi.org/10.3238/arztebl.2012.0674
Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, Group C. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295: 1152–1160. DOI: https://doi.org/10.1001/jama.295.10.1152
Meng K, Seekatz B, Roßband H, Worringen U, Faller H, Vogel H. Entwicklung eines standardisierten Rückenschulungsprogramms für die orthopädische Rehabilitation. Rehabilitation 2009; 48: 335–344. DOI: https://doi.org/10.1055/s-0029-1239575
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014; 348: g1687. DOI: https://doi.org/10.1136/bmj.g1687
Rhon DI, Fritz JM, Kerns RD, McGeary DD, Coleman BC, Farrokhi S, et al. TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials – unique considerations for the template for the intervention description and replication (TIDieR) checklist. BMC Med Res Methodol 2022; 22: 161. DOI: https://doi.org/10.1186/s12874-022-01640-7
Mangels M, Schwarz S, Sohr G, Holme M, Rief W. Der Fragebogen zur Erfassung der schmerzspezifischen Selbstwirksamkeit (FESS). Diagnostica 2009; 55: 84–93. DOI: https://doi.org/10.1026/0012-1924.55.2.84
Nicholas MK. The pain self-efficacy questionnaire: taking pain into account. Eur J Pain 2007; 11: 153–163. DOI: https://doi.org/10.1016/j.ejpain.2005.12.008
Nübling M, Stößel U, Hasselhorn H-M, Michaelis M, Hofmann F. Methoden zur Erfassung psychischer Belastungen. BAuA; 2005.
Wirtz M, Farin E, Bengel J, Jäckel W, Hämmerer D, Gerdes N. IRES-24 Patientenfragebogen. Entwicklung der Kurzformeines Assessmentinstrumentes in der Rehabilitationmittels der Mixed-Rasch-Analyse. Diagnostica 2005; 51: 75–87. DOI: https://doi.org/10.1026/0012-1924.51.2.75
Geissner E. Verarbeitung chronischer Schmerzen – Skalen zur Erfassung der Schmerzbewältigung und der schmerzbedingten psychischen Beeinträchtigung. Z Klin Psychol Psychother. 1999; 28: 280–290. DOI: https://doi.org/10.1026//0084-5345.28.4.280
Norman CD, Skinner HA. eHEALS: the ehealth literacy scale. J Med Internet Res 2006; 8: e27. DOI: https://doi.org/10.2196/jmir.8.4.e27
Ilmarinen J. The work ability index (WAI). Occup Med 2007; 57: 160. DOI: https://doi.org/10.1093/occmed/kqm008
Bethge M, Spanier K, Neugebauer T, Mohnberg I, Radoschewski FM. Self-reported poor work ability – an indicator of need for rehabilitation? A cross-sectional study of a sample of German employees. Am J Phys Med Rehabil 2015; 94: 958–966. DOI: https://doi.org/10.1097/PHM.0000000000000281
Fauser D, Zeuner AK, Zimmer JM, Golla A, Schmitt N, Mau W, et al. Work ability score as predictor of rehabilitation, disability pensions and death? A German cohort study among employees with back pain. Work 2022; 73: 719–728. DOI: https://doi.org/10.3233/WOR-210987
El Fassi M, Bocquet V, Majery N, Lair ML, Couffignal S, Mairiaux P. Work ability assessment in a worker population: comparison and determinants of work ability index and work ability score. BMC Public Health 2013; 13: 305. DOI: https://doi.org/10.1186/1471-2458-13-305
Brooke J. SUS: a retrospective. J Usability Stud 2013; 8: 29–40
Bangor A, Kortum P, Miller J. An empirical evaluation of the system usability scale. Int J Hum-Comput Int 2008; 24: 574–594. DOI: https://doi.org/10.1080/10447310802205776
Thielsch M, Salaschek M. Toolbox zur kontinuierlichen Website-Evaluation und Qualitätssicherung. Cologne: BZgA; 2017.
Dube MO, Langevin P, Roy JS. Measurement properties of the pain self-efficacy questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep 2021; 6: e972. DOI: https://doi.org/10.1097/PR9.0000000000000972
Dasgupta A, Lawson KA, Wilson JP. Evaluating equivalence and noninferiority trials. Am J Health Syst Pharm 2010; 67: 1337–1343. DOI: https://doi.org/10.2146/ajhp090507
White IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med 2011; 30: 377–399. DOI: https://doi.org/10.1002/sim.4067
Royston P, White IR. Multiple imputation by chained equations (MICE): implementation in Stata. J Stat Softw 2011; 45: 1–20. DOI: https://doi.org/10.18637/jss.v045.i04
Little R, Rubin D. Statistical analysis with missing data. Hoboken: Wiley; 2002. DOI: https://doi.org/10.1002/9781119013563
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332. DOI: https://doi.org/10.1136/bmj.c332
Giustiniani A, Danesin L, Pezzetta R, Masina F, Oliva G, Arcara G, et al. Use of telemedicine to improve cognitive functions and psychological well-being in patients with breast cancer: a systematic review of the current literature. Cancers 2023; 15. DOI: https://doi.org/10.3390/cancers15041353
Toonders SAJ, van der Meer HA, van Bruxvoort T, Veenhof C, Speksnijder CM. Effectiveness of remote physiotherapeutic e-Health interventions on pain in patients with musculoskeletal disorders: a systematic review. Disabil Rehabil 2023; 45: 3620–3638. DOI: https://doi.org/10.1080/09638288.2022.2135775
Leon-Salas B, Gonzalez-Hernandez Y, Infante-Ventura D, de Armas-Castellano A, Garcia-Garcia J, Garcia-Hernandez M, et al. Telemedicine for neurological diseases: a systematic review and meta-analysis. Eur J Neurol 2023; 30: 241–254. DOI: https://doi.org/10.1111/ene.15599
Pescaru CC, Crisan AF, Marc M, Trusculescu AA, Maritescu A, Pescaru A, et al. A systematic review of telemedicine-driven pulmonary rehabilitation after the acute phase of COVID-19. J Clin Med 2023; 12: 4854. DOI: https://doi.org/10.3390/jcm12144854
Dawson R, Oliveira JS, Kwok WS, Bratland M, Rajendran IM, Srinivasan A, et al. Exercise interventions delivered through telehealth to improve physical functioning for older adults with frailty, cognitive, or mobility disability: a systematic review and meta-analysis. Telemed J E Health 2024; 30: 940–950. DOI: https://doi.org/10.1089/tmj.2023.0177
Moreno-Ligero M, Moral-Munoz JA, Salazar A, Failde I. mHealth intervention for improving pain, quality of life, and functional disability in patients with chronic pain: systematic review. JMIR Mhealth Uhealth 2023; 11: e40844. DOI: https://doi.org/10.2196/40844
Martinez-Pozas O, Corbellini C, Cuenca-Zaldivar JN, Melendez-Oliva E, Sinatti P, Sanchez Romero EA. Effectiveness of telerehabilitation versus face-to-face pulmonary rehabilitation on physical function and quality of life in people with post COVID-19 condition: a systematic review and network meta-analysis. Eur J Phys Rehabil Med 2024; 60: 868–877. DOI: https://doi.org/10.23736/S1973-9087.24.08540-X
McLaughlin KH, Fritz JM, Minick KI, Brennan GP, McGee T, Lane E, et al. Examining the relationship between individual patient factors and substantial clinical benefit from telerehabilitation among patients with chronic low back pain. Phys Ther 2024; 104: pzad180. DOI: https://doi.org/10.1093/ptj/pzad180
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