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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Enhanced TA; Other: Limited TA; Other: Therapeutic exercise protocol.

• Registration Number: NCT04390932
• Lead Sponsor: Universidad Catolica de Temuco

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.

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 Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-18
• Study Start: 2023-12-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-28
• Study Completion: 2025-03-28
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced TA	Enhanced TA	Therapeutic exercise protocol accompanied by an enhanced TA.
Enhanced TA	Therapeutic exercise protocol.	Therapeutic exercise protocol accompanied by an enhanced TA.
Neutral therapeutic alliance	Limited TA	Therapeutic exercise protocol accompanied by an limited TA
Neutral therapeutic alliance	Therapeutic exercise protocol.	Therapeutic exercise protocol accompanied by an limited TA

Primary Outcome Measures

Name	Time	Method
Pain intensity	48 hours post intervention	Change in numerical pain rating scale (PI-NRS)
Pressure pain thresholds	48 hours post intervention	Change in pressure algometry

Trial Locations

Locations (1)

UC Temuco; 🇨🇱 Temuco, Chile