The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis. (ALLIANCE)

The Impact of Therapeutic Alliance on Clinical Outcomes in Patients With Symptomatic Knee Osteoarthritis. A Randomized Clinical Trial Protocol.

The therapeutic alliance (TA) is the working relationship or positive social bond between the patient and the therapist. TA is based on collaboration, communication, empathy of the therapist and mutual respect. Fostering an enhanced therapeutic alliance is a low-cost, therapist-dependent strategy that can accompany any clinical intervention. Growing evidence suggests that the TA plays a pivotal role in clinical outcomes in psychotherapy, medicine and physiotherapy interventions for chronic low back pain. On the other hand, therapeutic exercise is an economic, accessible and simple intervention strategy that has proven to be effective and safe to decrease pain and improve physical function in people with knee osteoarthritis (OA). To date, the role of TA in the management of knee OA is unknown. We hypothesized that a therapeutic exercise protocol accompanied by an enhanced TA could reduce the severity of symptoms and improve function in patients with symptomatic knee OA.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Enhanced TA; Other: Therapeutic exercise protocol.; Other: Limited TA

Detailed Description

The objective of this randomized clinical trial will be to determine the effects of different levels of TA during the application of a therapeutic exercise program on pain intensity, pressure pain thresholds and function in patients with symptomatic knee OA.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iván A Cuyul-Vásquez; Phone Number: +56990914987; Email: ivancuyul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- People aged 45 to 65 years with a clinical and radiographic diagnosis of knee osteoarthritis (grade I-III according to Kellgren and Lawrance), symptomatic with pain intensity between 3 and 8 points in the PI-NRS with at least 3 months duration, resulting in a mild to moderate level of disability (WOMAC).

Exclusion Criteria:

- People with other musculoskeletal, neurological, or immune conditions that cause pain or functional limitation in the lower extremities (hip osteoarthritis, patellar tendinopathy, sprains, radiculopathies, rheumatoid arthritis, systemic lupus erythematosus), history of trauma less than a year ago ( knee fractures, meniscal or ligament tears) or surgery of any kind on the lower extremity. Knee mobility less than 90º flexion. People in treatment with oral or intra-articular corticosteroids, antibiotics or exogenous opioids of any kind, with unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow physical exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced TA; Therapeutic exercise protocol accompanied by an enhanced TA.	Other: Enhanced TA; The enhanced TA is characterized by the personalization of the conversation, the verbalization of a joint participation in the process, the full presence of the therapist in the development of the exercise protocol, and the inclusion of behaviors such as active listening, empathy, and encouragement. In addition, therapist's body language transmits confidence, security, and attention.; Other: Therapeutic exercise protocol.; Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.
Active Comparator: Neutral therapeutic alliance; Therapeutic exercise protocol accompanied by an limited TA	Other: Therapeutic exercise protocol.; Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.; Other: Limited TA; The limited TA does not consider the personalization of the conversation, uses a unidirectional verbalization and is imperative about the instructions provided to the participant, the therapist is intermittently absent during the therapeutic exercise sessions and uses a neutral or negative nonverbal language cues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Change in numerical pain rating scale (PI-NRS)	48 hours post intervention
Pressure pain thresholds	Change in pressure algometry	48 hours post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb function	WOMAC physical function section	Only in the evaluation of the baseline.
Therapeutic alliance	Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES)	48 hours post intervention
Expectations level	Credibility and Expectations Questionnaire	Only in the evaluation of the baseline.
Conditioned pain modulation	Change in pressure algometry after application of cold inmmersion test	Only in the evaluation of the baseline.
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	Only in the evaluation of the baseline.

Collaborators and Investigators

• Sponsor: Universidad Catolica de Temuco
• Investigators: Principal Investigator: Iván A Cuyul-Vásquez, Universidad Catolica de Temuco

Publications and helpful links

General Publications

• Cuyul-Vasquez 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 Apr 16;21(3):e8160. doi: 10.5867/medwave.2021.03.8159.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Professional-Patient Relations; Therapeutic Alliance; Exercise Therapy.
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RCTKINE2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No