The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis.

NCT04390932 | Completed

• 1 other identifier: RCTKINE2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Therapeutic Alliance; Professional-Patient Relations; Pain; Osteoarthritis; Exercise Therapy.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Lower limb function

  Only in the evaluation of the baseline.

• Therapeutic alliance

  48 hours post intervention

• Expectations level

  Only in the evaluation of the baseline.

Study Arms (2)

Enhanced TA

EXPERIMENTAL

Therapeutic exercise protocol accompanied by an enhanced TA.

Other: Enhanced TA; Other: Therapeutic exercise protocol.

Neutral therapeutic alliance

ACTIVE COMPARATOR

Therapeutic exercise protocol accompanied by an limited TA

Other: Limited TA; Other: Therapeutic exercise protocol.

Interventions

Enhanced TA OTHER

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.

Enhanced TA

Limited TA OTHER

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.

Neutral therapeutic alliance

Therapeutic exercise protocol. OTHER

Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.

Enhanced TA; Neutral therapeutic alliance

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Universidad Catolica de Temuco: lead

Study Sites (1)

UC Temuco

Temuco, Chile

Location

Related Publications (1)

• 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.

  PMID: 33956775 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iván A Cuyul-Vásquez

  Universidad Catolica de Temuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: December 1, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)