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

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

Affiliation:
[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

Author address:
[1] Av. San Miguel 3605, Talca,
Chile
Zip code: 3460000

Citation: 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

Submission date: 22/11/2020

Acceptance date: 23/3/2021

Publication date: 16/4/2021

Origin: Not commissioned.

Type of review: Externally peer-reviewed by three reviewers, double-blind.

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1. 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 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
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16. 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 |
17. 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 |
18. 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 |
19. 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 |
20. 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 |
21. 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 |
22. 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 |
23. 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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28. Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, et al. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part three: aerobic exercise programs. Clin Rehabil. 2017 May;31(5):612-624. | CrossRef | PubMed |
29. Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. | CrossRef | PubMed |
30. Lima YL, Ferreira VMLM, de Paula Lima PO, Bezerra MA, de Oliveira RR, Almeida GPL. The association of ankle dorsiflexion and dynamic knee valgus: A systematic review and meta-analysis. Phys Ther Sport. 2018 Jan;29:61-69. | CrossRef | PubMed |
31. Fingleton C, Smart KM, Doody CM. Exercise-induced Hypoalgesia in People With Knee Osteoarthritis With Normal and Abnormal Conditioned Pain Modulation. Clin J Pain. 2017 May;33(5):395-404. | CrossRef | PubMed |
32. 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 |
33. Raghava Neelapala YV, Bhagat M, Shah P. Hip Muscle Strengthening for Knee Osteoarthritis: A Systematic Review of Literature. J Geriatr Phys Ther. 2020 Apr/Jun;43(2):89-98. | CrossRef | PubMed |
34. Hislop AC, Collins NJ, Tucker K, Deasy M, Semciw AI. Does adding hip exercises to quadriceps exercises result in superior outcomes in pain, function and quality of life for people with knee osteoarthritis? A systematic review and meta-analysis. Br J Sports Med. 2020 Mar;54(5):263-271. | CrossRef | PubMed |
35. Morishita S, Tsubaki A, Nakamura M, Nashimoto S, Fu JB, Onishi H. Rating of perceived exertion on resistance training in elderly subjects. Expert Rev Cardiovasc Ther. 2019 Feb;17(2):135-142. | CrossRef | PubMed |
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39. Srimurugan Pratheep N, Madeleine P, Arendt-Nielsen L. Relative and absolute test-retest reliabilities of pressure pain threshold in patients with knee osteoarthritis. Scand J Pain. 2018 Apr 25;18(2):229-236. | CrossRef | PubMed |
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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 |

Vong SK, Cheing GL, Chan F, So EM, Chan CC. Motivational enhancement therapy in addition to physical therapy improves motivational factors and treatment outcomes in people with low back pain: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):176-83. | CrossRef | PubMed |

Ruben MA, Blanch-Hartigan D, Hall JA. Nonverbal Communication as a Pain Reliever: The Impact of Physician Supportive Nonverbal Behavior on Experimentally Induced Pain. Health Commun. 2017 Aug;32(8):970-976. | CrossRef | PubMed |

Cuyul-Vásquez I, Barría JA, Perez NF, et al. The influence of verbal suggestions in the management of musculoskeletal pain: a narrative review. Phys Ther Rev Published Online First: 2019. | CrossRef |

Juhl C, Christensen R, Roos EM, Zhang W, Lund H. Impact of exercise type and dose on pain and disability in knee osteoarthritis: a systematic review and meta-regression analysis of randomized controlled trials. Arthritis Rheumatol. 2014 Mar;66(3):622-36. | CrossRef | PubMed |

Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, et al. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part three: aerobic exercise programs. Clin Rehabil. 2017 May;31(5):612-624. | CrossRef | PubMed |

Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. | CrossRef | PubMed |

Lima YL, Ferreira VMLM, de Paula Lima PO, Bezerra MA, de Oliveira RR, Almeida GPL. The association of ankle dorsiflexion and dynamic knee valgus: A systematic review and meta-analysis. Phys Ther Sport. 2018 Jan;29:61-69. | CrossRef | PubMed |

Fingleton C, Smart KM, Doody CM. Exercise-induced Hypoalgesia in People With Knee Osteoarthritis With Normal and Abnormal Conditioned Pain Modulation. Clin J Pain. 2017 May;33(5):395-404. | 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 |

Raghava Neelapala YV, Bhagat M, Shah P. Hip Muscle Strengthening for Knee Osteoarthritis: A Systematic Review of Literature. J Geriatr Phys Ther. 2020 Apr/Jun;43(2):89-98. | CrossRef | PubMed |

Hislop AC, Collins NJ, Tucker K, Deasy M, Semciw AI. Does adding hip exercises to quadriceps exercises result in superior outcomes in pain, function and quality of life for people with knee osteoarthritis? A systematic review and meta-analysis. Br J Sports Med. 2020 Mar;54(5):263-271. | CrossRef | PubMed |

Morishita S, Tsubaki A, Nakamura M, Nashimoto S, Fu JB, Onishi H. Rating of perceived exertion on resistance training in elderly subjects. Expert Rev Cardiovasc Ther. 2019 Feb;17(2):135-142. | CrossRef | PubMed |

Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. | CrossRef | PubMed |

Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. | CrossRef | PubMed |

Stauffer ME, Taylor SD, Watson DJ, Peloso PM, Morrison A. Definition of nonresponse to analgesic treatment of arthritic pain: an analytical literature review of the smallest detectable difference, the minimal detectable change, and the minimal clinically important difference on the pain visual analog scale. Int J Inflam. 2011;2011:231926. | CrossRef | PubMed |

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