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Completed

NCT Number: NCT04390932

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Temuco

Temuco, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pain intensity

    Time frame: 48 hours post intervention

    Change in numerical pain rating scale (PI-NRS)

  2. Pressure pain thresholds

    Time frame: 48 hours post intervention

    Change in pressure algometry

Other outcomes

  1. Lower limb function

    Time frame: Only in the evaluation of the baseline.

    WOMAC physical function section

  2. Therapeutic alliance

    Time frame: 48 hours post intervention

    Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES)

  3. Expectations level

    Time frame: Only in the evaluation of the baseline.

    Credibility and Expectations Questionnaire

  4. Conditioned pain modulation

    Time frame: Only in the evaluation of the baseline.

    Change in pressure algometry after application of cold inmmersion test

  5. Anxiety and depression

    Time frame: Only in the evaluation of the baseline.

    Hospital Anxiety and Depression Scale (HADS)

Sponsors and collaborators

Lead sponsor

Universidad Catolica de Temuco

Other

Registry information

Official study title

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

Acronym: ALLIANCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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