Protocolo
Medwave 2021;21(03):e8159 doi: 10.5867/medwave.2021.03.8159
Efectos de la alianza terapéutica en los resultados clínicos en pacientes con osteoartritis de rodilla sintomática sometidos a un programa de ejercicio: protocolo de ensayo clínico aleatorizado
Effects of therapeutic alliance on clinical outcomes in patients with symptomatic knee osteoarthritis undergoing an exercise program: A randomized clinical trial protocol
Iván Cuyul-Vásquez, Jorge Fuentes C.
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Palabras clave: Therapeutic Alliance, Contextual factors, Pain, Osteoarthritis, Exercise Therapy

Resumen

Antecedentes
Evidencia previa ha demostrado que los fisioterapeutas expertos que aplican electroterapia junto con una alianza terapéutica mejorada pueden influir positivamente en los niveles de analgesia de los pacientes con dolor lumbar crónico. Actualmente se desconoce si estos efectos se pueden lograr en personas con artrosis de rodilla sintomática cuando reciben un tratamiento basado en ejercicio terapéutico.

Objetivo
Determinar los efectos de diferentes niveles de alianza terapéutica durante la aplicación de un programa de ejercicio terapéutico sobre la intensidad del dolor y el umbral del dolor a la presión en pacientes con artrosis de rodilla sintomática.

Método
Este será un ensayo clínico aleatorizado, paralelo, de dos brazos. Se aplicará una intervención de tres sesiones de ejercicio terapéutico durante una semana. Participarán personas de 45 a 65 años con diagnóstico clínico y radiográfico de artrosis de rodilla sintomática, con intensidad del dolor entre 4-7 puntos en la escala numérica del dolor con al menos 3 meses de duración. Los participantes serán asignados al azar a un grupo experimental de ejercicio terapéutico con una alianza terapéutica mejorada (por ejemplo, escucha activa, conversación personalizada, empatía) o alianza terapéutica limitada (por ejemplo, verbalización unidireccional, breve interacción). Se capacitará a los fisioterapeutas para brindar estos dos niveles de alianza terapéutica. Los umbrales del dolor a la presión en la rodilla sintomática y la intensidad del dolor se medirán antes y después de la intervención.

Discusión
Los resultados de esta investigación determinarán el impacto de la alianza terapéutica como factor inespecífico durante la aplicación de un programa de ejercicio terapéutico en el tratamiento de pacientes con artrosis de rodilla sintomática.

Número de registro de Ensayos Clínicos
NCT04390932


 

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Background
Previous evidence has shown that seniors physical therapists applying electrotherapy and an enhanced therapeutic alliance in their sessions can positively influence the levels of analgesia of patients with chronic low back pain. It is currently unknown if these effects can be achieved in people with symptomatic knee osteoarthritis when receiving treatment focused on therapeutic exercise.

Aim
To determine the effects of different therapeutic alliance levels during the application of a therapeutic exercise program on pain intensity and pressure pain threshold in patients with symptomatic knee osteoarthritis.

Method
This will be a randomized, parallel, two-arm, clinical trial. An intervention of three sessions of therapeutic exercise will be applied for one week. Patients aged 45 to 65 years old with a clinical and radiographic diagnosis of knee osteoarthritis will participate. Also, patients with a pain intensity of at least three months duration and 3 to 8 points in a numerical rating scale will be included. Patients will be randomly assigned to a therapeutic exercise experimental group with an enhanced therapeutic alliance (e.g., active listening, personalized conversation, empathy) or limited therapeutic alliance (e.g., one-way verbalization, brief interaction). Physical therapists will be trained in delivering these two levels of the therapeutic alliance. The pressure pain thresholds at the symptomatic knee and the pain intensity will be measured before and after the intervention.

Discussion
The results of this research will determine the impact of the therapeutic alliance as a nonspecific relevant factor during the application of a therapeutic exercise program in the treatment of patients with symptomatic knee osteoarthritis.

Clinical trials registration number
NCT04390932

Autores: Iván Cuyul-Vásquez[1], Jorge Fuentes C.[2]

Filiación:
[1] Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Temuco, Chile
[2] Laboratorio de Investigación Clínica, Departamento de Kinesiología, Universidad Católica del Maule, Talca, Chile

E-mail: jorgef@ualberta.ca

Correspondencia a:
[1] Av. San Miguel 3605, Talca,
Chile
Zip code: 3460000

Citación: Cuyul-Vásquez I, Fuentes C. J. Effects of therapeutic alliance on clinical outcomes in patients with symptomatic knee osteoarthritis undergoing an exercise program: A randomized clinical trial protocol. Medwave 2021;21(03):e8159 doi: 10.5867/medwave.2021.03.8159

Fecha de envío: 22/11/2020

Fecha de aceptación: 23/3/2021

Fecha de publicación: 16/4/2021

Origen: No solicitado.

Tipo de revisión: Con revisión por pares externa, por tres árbitros a doble ciego.

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Farrokhi S, Chen YF, Piva SR, Fitzgerald GK, Jeong JH, Kwoh CK. The Influence of Knee Pain Location on Symptoms, Functional Status, and Knee-related Quality of Life in Older Adults With Chronic Knee Pain: Data From the Osteoarthritis Initiative. Clin J Pain. 2016 Jun;32(6):463-70. | CrossRef | PubMed |

GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. | CrossRef | PubMed |

Driban JB, Sitler MR, Barbe MF, Balasubramanian E. Is osteoarthritis a heterogeneous disease that can be stratified into subsets? Clin Rheumatol. 2010 Feb;29(2):123-31. | CrossRef | PubMed |

Bedson J, Croft PR. The discordance between clinical and radiographic knee osteoarthritis: a systematic search and summary of the literature. BMC Musculoskelet Disord. 2008 Sep 2;9:116. | CrossRef | PubMed |

Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. | CrossRef | PubMed |

Calders P, Van Ginckel A. Presence of comorbidities and prognosis of clinical symptoms in knee and/or hip osteoarthritis: A systematic review and meta- analysis. Semin Arthritis Rheum. 2018 Jun;47(6):805-813. | CrossRef | PubMed |

Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, et al. 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis. Ann Rheum Dis. 2018 Sep;77(9):1251-1260. | CrossRef | PubMed |

Uthman OA, van der Windt DA, Jordan JL, Dziedzic KS, Healey EL, Peat GM, et al. Exercise for lower limb osteoarthritis: systematic review incorporating trial sequential analysis and network meta-analysis. BMJ. 2013 Sep 20;347:f5555. | CrossRef | PubMed |

Lun V, Marsh A, Bray R, Lindsay D, Wiley P. Efficacy of Hip Strengthening Exercises Compared With Leg Strengthening Exercises on Knee Pain, Function, and Quality of Life in Patients With Knee Osteoarthritis. Clin J Sport Med. 2015 Nov;25(6):509-17. | CrossRef | PubMed |

Anwer S, Alghadir A. Effect of isometric quadriceps exercise on muscle strength, pain, and function in patients with knee osteoarthritis: a randomized controlled study. J Phys Ther Sci. 2014 May;26(5):745-8. | CrossRef | PubMed |

Li Y, Su Y, Chen S, Zhang Y, Zhang Z, Liu C, et al. The effects of resistance exercise in patients with knee osteoarthritis: a systematic review and meta-analysis. Clin Rehabil. 2016 Oct;30(10):947-959. | CrossRef | PubMed |

Tanaka R, Ozawa J, Kito N, Moriyama H. Efficacy of strengthening or aerobic exercise on pain relief in people with knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2013 Dec;27(12):1059-71. | CrossRef | PubMed |

Kabiri S, Halabchi F, Angoorani H, Yekaninejad S. Comparison of three modes of aerobic exercise combined with resistance training on the pain and function of patients with knee osteoarthritis: A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:22-28. | CrossRef | PubMed |

Rossettini G, Camerone EM, Carlino E, Benedetti F, Testa M. Context matters: the psychoneurobiological determinants of placebo, nocebo and context-related effects in physiotherapy. Arch Physiother. 2020 Jun 11;10:11. | CrossRef | PubMed |

Nicolson PJA, Bennell KL, Dobson FL, Van Ginckel A, Holden MA, Hinman RS. Interventions to increase adherence to therapeutic exercise in older adults with low back pain and/or hip/knee osteoarthritis: a systematic review and meta- analysis. Br J Sports Med. 2017 May;51(10):791-799. | CrossRef | PubMed |

Kuru Çolak T, Kavlak B, Aydoğdu O, Şahin E, Acar G, Demirbüken İ, et al. The effects of therapeutic exercises on pain, muscle strength, functional capacity, balance and hemodynamic parameters in knee osteoarthritis patients: a randomized controlled study of supervised versus home exercises. Rheumatol Int. 2017 Mar;37(3):399-407. | CrossRef | PubMed |

Babatunde F, MacDermid J, MacIntyre N. Characteristics of therapeutic alliance in musculoskeletal physiotherapy and occupational therapy practice: a scoping review of the literature. BMC Health Serv Res. 2017 May 30;17(1):375. | CrossRef | PubMed |

Ferreira PH, Ferreira ML, Maher CG, Refshauge KM, Latimer J, Adams RD. The therapeutic alliance between clinicians and patients predicts outcome in chronic low back pain. Phys Ther. 2013 Apr;93(4):470-8. | CrossRef | PubMed |

Wright BJ, Galtieri NJ, Fell M. Non-adherence to prescribed home rehabilitation exercises for musculoskeletal injuries: the role of the patient- practitioner relationship. J Rehabil Med. 2014 Feb;46(2):153-8. | CrossRef | PubMed |

Kinney M, Seider J, Beaty AF, Coughlin K, Dyal M, Clewley D. The impact of therapeutic alliance in physical therapy for chronic musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2020 Aug;36(8):886-898. | CrossRef | PubMed |

Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren- Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. | CrossRef | PubMed |

Kapstad H, Hanestad BR, Langeland N, Rustøen T, Stavem K. Cutpoints for mild, moderate and severe pain in patients with osteoarthritis of the hip or knee ready for joint replacement surgery. BMC Musculoskelet Disord. 2008 Apr 21;9:55. | CrossRef | PubMed |

Fuentes J, Armijo-Olivo S, Funabashi M, Miciak M, Dick B, Warren S, et al. Enhanced therapeutic alliance modulates pain intensity and muscle pain sensitivity in patients with chronic low back pain: an experimental controlled study. Phys Ther. 2014 Apr;94(4):477-89. | CrossRef | PubMed |

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